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Get all SOPs of these all departments. Calibration and operating procedures of all quality control instruments and operating procedures of all production equipment are also provided on the website. All GMP topics are also covered for quality assurance."},"link":[{"rel":"http://schemas.google.com/g/2005#feed","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/posts\/default"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default?alt=json-in-script\u0026orderby=published"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/"},{"rel":"hub","href":"http://pubsubhubbub.appspot.com/"},{"rel":"next","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default?alt=json-in-script\u0026start-index=26\u0026max-results=25\u0026orderby=published"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"generator":{"version":"7.00","uri":"http://www.blogger.com","$t":"Blogger"},"openSearch$totalResults":{"$t":"2264"},"openSearch$startIndex":{"$t":"1"},"openSearch$itemsPerPage":{"$t":"25"},"entry":[{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-4080435784701151080"},"published":{"$t":"2023-12-15T22:38:00.000+05:30"},"updated":{"$t":"2023-12-15T22:38:01.138+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Audit"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GDP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"}],"title":{"type":"text","$t":"Determination of Data Integrity Compliance in Pharmaceuticals"},"content":{"type":"html","$t":"Data integrity is the principle of generating, maintaining and assuring the consistent accuracy and completeness of data in a company or manufacturing plant through the entire life cycle complying with the regulations set within the pharmaceutical industry by the Food and Drug Administration (FDA). \u003Ca href=\"https:\/\/www.pharmaguideline.com\/2018\/10\/data-integration-as-per-21-cfr-rules.html\" target=\"_blank\"\u003EData integrity\u003C\/a\u003E compliance is the key issue to be looked into especially in pharmaceuticals because this is the most sensitive sector dealing with individuals health.\u003Cbr\u003E\n\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2019\/03\/determination-of-data-integrity-compliance.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/4080435784701151080\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2019\/03\/determination-of-data-integrity-compliance.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/4080435784701151080"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/4080435784701151080"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2019\/03\/determination-of-data-integrity-compliance.html","title":"Determination of Data Integrity Compliance in Pharmaceuticals"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/3.bp.blogspot.com\/-YHt2Uq0Kyw0\/XIU1gG-zAuI\/AAAAAAAAH7A\/ZHzIronVYs8fPi0lm2WUboSvziDCE4_ywCLcBGAs\/s72-c\/data-integrity-pharma.jpg","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-6172930915696648130"},"published":{"$t":"2023-12-14T23:16:00.000+05:30"},"updated":{"$t":"2023-12-14T23:16:50.717+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Audit"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GLP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"}],"title":{"type":"text","$t":"6 Ways to Reduce Human Errors in Pharmaceuticals"},"content":{"type":"html","$t":"\u003Cdiv style=\"text-align: justify;\"\u003E\nHuman errors have critical effects on pharmaceutical product quality. About 80% of the product quality issues occur due to the human errors. Human errors are traced by the occurrence of the deviations in the process. Most of the root causes of deviations are human errors due to improper communication or failure to follow the written procedure.\u003C\/div\u003E\n\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2016\/05\/6-ways-to-reduce-human-errors-in-pharmaceuticals.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/6172930915696648130\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2016\/05\/6-ways-to-reduce-human-errors-in-pharmaceuticals.html#comment-form","title":"1 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/6172930915696648130"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/6172930915696648130"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2016\/05\/6-ways-to-reduce-human-errors-in-pharmaceuticals.html","title":"6 Ways to Reduce Human Errors in Pharmaceuticals"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/1.bp.blogspot.com\/-D63Nvf4XbY0\/V0svB5q65pI\/AAAAAAAAFZg\/3gU1nA-Bzbw078RSVofxF-yMyXhBYCgTACLcB\/s72-c\/human-error.jpg","height":"72","width":"72"},"thr$total":{"$t":"1"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-840209835181569809"},"published":{"$t":"2023-12-13T23:08:00.001+05:30"},"updated":{"$t":"2023-12-13T23:08:08.742+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Audit"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GDP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"}],"title":{"type":"text","$t":"Key Preposes of Change Control in Pharmaceuticals"},"content":{"type":"html","$t":"Change control is an important part of the pharmaceutical \u003Ca href=\"https:\/\/www.pharmaguideline.com\/2016\/10\/quality-management-system-qms.html\" target=\"_blank\"\u003Equality management system\u003C\/a\u003E. It ensures that all changes are done in a controlled manner and changes made in the system do not have any adverse impact on the product quality. In this article, we will discuss the main purpose of the change control in pharmaceuticals.\u003Cspan\u003E\u003C\/span\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2023\/12\/prepose-of-change-control.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/840209835181569809\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/12\/prepose-of-change-control.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/840209835181569809"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/840209835181569809"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/12\/prepose-of-change-control.html","title":"Key Preposes of Change Control in Pharmaceuticals"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgIG0I71DzbjPfpOdQQkBCEi-g7yLJUc7Loy_skZZJlFBnKkPpTFIBGbfev_JKPcpeC7xnWiAPNFmkZSpGNAi5DjqrNlvUs1FUDb2I_X5Zvv3SYEqWc8PIdgO9yk8MI5BZooR_Rn7KH0LpcIkwT_GY-QtHxiIHoFD0cN6GCK0-8fooixvFLGHWjNlYBR_tu\/s72-w320-h260-c\/change-control.png","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-66120117584555901"},"published":{"$t":"2023-12-12T21:10:00.000+05:30"},"updated":{"$t":"2023-12-12T21:10:02.562+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Audit"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"}],"title":{"type":"text","$t":"How to respond to an FDA 483 observations?"},"content":{"type":"html","$t":"FDA 483s are the observations found during the inspection of a pharmaceutical manufacturing facility. These observations are documented on a form known as form 483. After getting a notice from FDA on form 483 manufacturing facility has to respond to FDA about the actions taken on the observations. It is not a difficult task to respond to FDA if you have a plan.\u003Cspan\u003E\u003C\/span\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2023\/03\/how-to-respond-to-fda-483-observations.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/66120117584555901\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/03\/how-to-respond-to-fda-483-observations.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/66120117584555901"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/66120117584555901"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/03\/how-to-respond-to-fda-483-observations.html","title":"How to respond to an FDA 483 observations?"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEg1JEt0-6ed5csY-aYw_xQsCeO8NJgZPaLgANUTSRuhl2kScPCjVdQ6K93OnSeIhamtubabrPH_mkJ7Mx1EFFBJA0Yzk8U-Vp2xzNQoprEUw4M28g06H4nJdX7SSME_gvmsh7g2tfZ1hpqN9ymw0LwjEwQBNLsYVyl5PauaoRnbE8otBL2gOySJ7XzJCg\/s72-w320-h247-c\/483-observations.png","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-2102017817771318789"},"published":{"$t":"2023-12-10T22:49:00.000+05:30"},"updated":{"$t":"2023-12-10T22:49:06.471+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"GDP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Quality Assurance"}],"title":{"type":"text","$t":"Different Types of Deviations in Pharmaceuticals"},"content":{"type":"html","$t":"Deviation management is an important part of pharmaceutical documentation. A lot of FDA warning letters are issued due to the improper handling of the deviations. Deviations are the departure of any process or procedure from a documented or expected value. \u003Ca href=\"https:\/\/www.pharmaguideline.com\/2011\/01\/deviation-control.html\" target=\"_blank\"\u003EDeviation\u003C\/a\u003E may be in the form of value, process, or procedure that is different from the standard or guideline.\u003Cspan\u003E\u003C\/span\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2023\/12\/different-types-of-deviations.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/2102017817771318789\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/12\/different-types-of-deviations.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/2102017817771318789"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/2102017817771318789"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/12\/different-types-of-deviations.html","title":"Different Types of Deviations in Pharmaceuticals"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgsmu7DNl-phPWq9TOcZTfGaRIqw8B7qnQ49kPv24VUudPoR6yirkdcPkLR-9uoxFrbRb1Vu68ZDQGYZzcu_Jxp0w2VhHYKYfNLwPeIc5Qs_IP3-Nj3k6rT7ie6YSKtM6vVU2ZlAm5r5YZ0By5zlo79I3xt8Yecpz4TgZnfzDFfuthY5-w-Kxm-fBbIc7Nv\/s72-c\/deviation.jpeg","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-8781736001353249726"},"published":{"$t":"2023-12-07T21:58:00.002+05:30"},"updated":{"$t":"2023-12-10T23:12:17.408+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Data Integrity"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Production"}],"title":{"type":"text","$t":"Different Ways to Improve Pharmaceutical Productivity and Product Quality"},"content":{"type":"html","$t":"Every business owner wants to produce more products to achieve the new milestones in manufacturing. The pharmaceutical field is different from the others in the quality of products. It is a great idea to scale up the production but at the same time, product quality must not be compromised. Following are some proven ways to improve productivity without compromising product quality.\u003Cspan\u003E\u003C\/span\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2023\/12\/different-ways-to-improve-productivity-and-quality.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/8781736001353249726\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/12\/different-ways-to-improve-productivity-and-quality.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/8781736001353249726"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/8781736001353249726"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/12\/different-ways-to-improve-productivity-and-quality.html","title":"Different Ways to Improve Pharmaceutical Productivity and Product Quality"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEhnmYr70j4ol7OEC7VOZWUTxtUyenm2mTohqKrxHC4EkarntM7CKumoDlzOMyNBhYhFv_2g8oTUKhDZmDZfAP4g_ToCZvdqwxj2RiEPJWagYPf491OvTFV9B8NhIDLB5aZadJbVpcSYvFhQ1o9jmjSLx4VThFlxRP4JnliAx65__GHABCRSPWUOK9T4h7Qw\/s72-w320-h254-c\/quality.jpeg","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-989115600101060877"},"published":{"$t":"2023-12-06T19:09:00.000+05:30"},"updated":{"$t":"2023-12-06T19:09:31.449+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Quality Assurance"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Validation"}],"title":{"type":"text","$t":"Procedure for Process Validation in Pharmaceuticals"},"content":{"type":"html","$t":"Process validation is an important part of pharmaceutical industry. It helps to identify and resolve the issues that arise during manufacturing process. Process validation ensures the consistency and reliability of the quality product manufacturing on pharmaceuticals. Following steps are followed during the validation of manufacturing process in pharmaceutical industry.\u003Cspan\u003E\u003C\/span\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2023\/12\/procedure-for-process-validation.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/989115600101060877\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/12\/procedure-for-process-validation.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/989115600101060877"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/989115600101060877"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/12\/procedure-for-process-validation.html","title":"Procedure for Process Validation in Pharmaceuticals"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEiVoYkptpJkDuBQzVq9uk9jsucMMzQbsJsS0SW8fOL5fk9vkOVAcoN3GNUcCB1Wj_tTG-oCXT3eJXgrZzuDQbdGybg8ih2bwOxHxZyAVawxXrzN2Z4415tgfn-rEwuc2f-qruk6eGpZLMdqu5c0fp0sFakQgPvs5Sk9bCp69xSjJ4HWesl9HIW6s36cj5BW\/s72-c\/process-validation.png","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-2988561077344217931"},"published":{"$t":"2023-11-24T21:28:00.000+05:30"},"updated":{"$t":"2023-11-24T21:28:08.647+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Microbiology"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Validation"}],"title":{"type":"text","$t":"What is Disinfectant Validation?"},"content":{"type":"html","$t":"Disinfectant validation is the process of determining whether a disinfectant is effective in cleaning a surface. The purpose of this process is to ensure that the disinfectant is effective and does not cause any harm to the environment or the people using it.\u003Cspan\u003E\u003C\/span\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2022\/07\/what-is-disinfectant-validation.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/2988561077344217931\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2022\/07\/what-is-disinfectant-validation.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/2988561077344217931"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/2988561077344217931"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2022\/07\/what-is-disinfectant-validation.html","title":"What is Disinfectant Validation?"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEhQlZ__-Lfw3CpDeapQNbC2nlcG0mJiJbZaspqUHkiHMd7P5zWWWW4wyqmxKyWGeL32lql7UUk6ec1n9hAl5kpEpAZTgpowJ4a-BkJuflSVvTCFZuIEFdWolA3RpiGpnQmCwizBBG7IaWY3eElIeYOAhyUAgUSbnHNNA6bBCrIAs6xkqv07YzIkO7a-Lg\/s72-w320-h225-c\/disinfectants-validation.png","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-792118200040462938"},"published":{"$t":"2023-11-17T05:26:00.000+05:30"},"updated":{"$t":"2023-11-24T21:31:21.158+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Cleaning Validation"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Validation"}],"title":{"type":"text","$t":"Basics of Cleaning Validation"},"content":{"type":"html","$t":"Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufactured are not contaminated. The removal of the residues of the previous products from manufacturing equipment is known as cleaning. If the whole process of cleaning has been documented, it is referred to as cleaning method validation.\u003Cbr\u003E\n\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2018\/08\/basics-of-cleaning-validation.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/792118200040462938\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2018\/08\/basics-of-cleaning-validation.html#comment-form","title":"11 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/792118200040462938"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/792118200040462938"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2018\/08\/basics-of-cleaning-validation.html","title":"Basics of Cleaning Validation"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/4.bp.blogspot.com\/-nQgrzaAwkK8\/W0HyQfvW-1I\/AAAAAAAAHbw\/qur7dK0IxwAPib-6OS3fbzbWXbMqhZf8wCLcBGAs\/s72-c\/clean-validation.jpg","height":"72","width":"72"},"thr$total":{"$t":"11"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-6515400172299792110"},"published":{"$t":"2023-11-12T19:55:00.000+05:30"},"updated":{"$t":"2023-11-24T21:30:54.542+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Protocol"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Validation"}],"title":{"type":"text","$t":"How to Effectively Execute a Validation Protocol?"},"content":{"type":"html","$t":"\u003Cdiv class=\"MsoNormal\" style=\"margin-bottom: 0.0001pt;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003EProper execution of protocol is an important part of the validation process. Execution of \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2014\/07\/how-to-write-validation-protocol.html\" target=\"_blank\"\u003Evalidation protocol\u003C\/a\u003E affects the validation results. There should be minimum deviations during the validation process.\u003C\/span\u003E\u003C\/div\u003E\n\u003Cbr\u003E\n\u003C\/div\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2014\/07\/how-effectively-execute-validation-protocol.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/6515400172299792110\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2014\/07\/how-effectively-execute-validation-protocol.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/6515400172299792110"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/6515400172299792110"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2014\/07\/how-effectively-execute-validation-protocol.html","title":"How to Effectively Execute a Validation Protocol?"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/4.bp.blogspot.com\/-yPFxc4vjeAQ\/Vx-u2Qe6lRI\/AAAAAAAAFWo\/IemuGbPNu8EKHJN-slu1YvXFpU8R-0jmACLcB\/s72-c\/validation-execution.jpg","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-160208035648424181"},"published":{"$t":"2023-11-08T19:00:00.000+05:30"},"updated":{"$t":"2023-11-08T19:00:29.047+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Quality Assurance"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Regulatory"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Validation"}],"title":{"type":"text","$t":"How to Write a Validation Master Plan?"},"content":{"type":"html","$t":"A Validation Master Plan (also referred to as the VMP) is a document which outlines the principles tied to the qualification of a certain facility, defining the systems and areas which need validation and provides a written guideline on how to achieve and then maintain a qualified facility. VMP is basically a summary of the validation strategy. It is a crucial segment of \u003Ca href=\"https:\/\/www.pharmaguideline.com\/2012\/08\/current-good-manufacturing-practice-cgmp.html\" target=\"_blank\"\u003EGood Manufacturing Practice\u003C\/a\u003E regulated pharmaceutical practice because it supports a structural approach to GMP validation projects.\u003Cbr\u003E\n\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2019\/03\/how-to-write-validation-master-plan.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/160208035648424181\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2019\/03\/how-to-write-validation-master-plan.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/160208035648424181"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/160208035648424181"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2019\/03\/how-to-write-validation-master-plan.html","title":"How to Write a Validation Master Plan?"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/4.bp.blogspot.com\/-bnp5oHv3zgQ\/XHuzfizXomI\/AAAAAAAAH58\/dO55x61ADVMw3pUubF0klZZq6xeLr9qVgCLcBGAs\/s72-c\/VMP.jpg","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-4811465468503454793"},"published":{"$t":"2023-11-06T18:45:00.000+05:30"},"updated":{"$t":"2023-11-06T18:45:39.133+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Article"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Pharmacology"}],"title":{"type":"text","$t":"The Role of Pharmacies in Precision Medicine"},"content":{"type":"html","$t":"Have you wondered how the same medicine is a good fit for different people with different genetic make-ups and lifestyles? It is not; our medication should be aligned with our individual needs and lifestyles to be optimally effective.\u003Cspan\u003E\u003C\/span\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2023\/11\/the-role-of-pharmacies-in-precision-medicine.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/4811465468503454793\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/11\/the-role-of-pharmacies-in-precision-medicine.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/4811465468503454793"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/4811465468503454793"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/11\/the-role-of-pharmacies-in-precision-medicine.html","title":"The Role of Pharmacies in Precision Medicine"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgENdTGQuRtdNfHDXFLU9NiiqVJaAS8gzatQQKn10R_2nuN0goA4OVVtLkKOHjX16QP59u0IwTWL-UMTH61GjbJbLsgTXsZ6zFHLyOeEryaLFJE3_WsM1Wz-SQobiMTRSr5JQw_zhRv5ZsFhasBB-PwAyQkcjwdzBIZNt2IrYC-HV4m_XUKaiRHd_YfxM20\/s72-w640-h427-c\/Precision-Medicines.png","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-2344258421139798915"},"published":{"$t":"2023-09-26T22:51:00.000+05:30"},"updated":{"$t":"2023-09-26T22:51:48.029+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Protocol"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Sterile"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Validation"}],"title":{"type":"text","$t":"Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals"},"content":{"type":"html","$t":"\u003Cdiv dir=\"ltr\" trbidi=\"on\"\u003E\n\u003Ch2\u003E\n1.0 OBJECTIVE\u003C\/h2\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E1.1 \u0026nbsp;To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system\/facility\/equipment.\u003C\/span\u003E\u003Cbr \/\u003E\n\u003Ch2\u003E\n2.0 SCOPE\u003C\/h2\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E2.1 \u0026nbsp;This procedure applies to all aseptically filled sterile products intended for human use.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cbr \/\u003E\n\u003Cga1\u003E\u003C\/ga1\u003E\n\n\u003Ch2\u003E\n3.0 RESPONSIBILITY\u003C\/h2\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E3.1 \u0026nbsp;The Validation personnel coordinate the aseptic filling validation program and write the sterile media aseptic filling processes reports.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E3.2 \u0026nbsp;Manufacturing personnel the sterile media aseptic filling processes and performs the sterile media fills.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cdiv class=\"separator\" style=\"clear: both; text-align: center;\"\u003E\n\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2011\/08\/aseptic-filling-process-media-fill.html\" style=\"clear: right; float: right; margin-bottom: 1em; margin-left: 1em;\"\u003E\u003Cimg alt=\"Media Fill Validation Test for Sterile Manufacturing\" border=\"0\" src=\"https:\/\/1.bp.blogspot.com\/-f45IK4CqRZs\/VpFWiF_l0WI\/AAAAAAAAFEA\/qijJPPRrKkI\/s1600\/media-fill.jpg\" title=\"Media Fill Validation Test for Sterile Manufacturing\" \/\u003E\u003C\/a\u003E\u003C\/div\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E3.3 \u0026nbsp;QA personnel perform the sampling and assist with the IPQA monitoring required for each sterile media fill.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E3.4 \u0026nbsp;QC personnel to perform the testing and assist with the monitoring required for each sterile media fill.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Ch2\u003E\n4.0 ACCOUNTABILITY\u003C\/h2\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E4.1 \u0026nbsp;Manager QA\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Ch2\u003E\n5.0 REFERENCE (S)\u003C\/h2\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E5.1 \u0026nbsp;In- house.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E5.2 \u0026nbsp;\u003C\/span\u003E\u003C\/span\u003E\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2010\/10\/pics-pharmaceutical-inspection.html\" target=\"_blank\"\u003EPharmaceutical Inspection convention Guideline.(PIC)\u003C\/a\u003E\u003C\/div\u003E\n\u003Ch2\u003E\n6.0 PROCEDURE\u003C\/h2\u003E\n\u003Cdiv\u003E\n\u003Ch3\u003E\n6.1 EXIT AND ENTRY PROCEDURE\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.1.1\u0026nbsp;\u0026nbsp;All Operators and Supervisors enter department as per Defined Gowning procedure.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cbr \/\u003E\n\u003Cga2\u003E\u003C\/ga2\u003E\n\n\u003Ch3\u003E\n6.2 AMPOULE FILLING MEDIA\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.1 \u0026nbsp;The media fill run shall be performed for approximately the same duration as required for filling of a normal production batch (approx. 12 hours).\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.2 \u0026nbsp;Batch (Media) manufacturing shall be done in the initial hours of the 1st shifts, followed by other processing steps normally followed.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.3 \u0026nbsp;Nitrogen flushing shall not to be done during media filling.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.4 \u0026nbsp;The filling of media shall be done in the following sequence:-\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E6.2.4.1\u0026nbsp;\u0026nbsp;The media (\u003C\/span\u003E\u003C\/span\u003E\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2011\/02\/culture-media.html\" target=\"_blank\"\u003ESoybean Casien Digest Madium\u003C\/a\u003E\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E) batch shall be manufactured in the manufacturing area. The bulk is then aseptically filtered into a sterile holding tank (under LAF) in the sterile area. The tank containing the filtered solution is then connected sterile silicon pipeline and filling done in\u0026nbsp;\u003C\/span\u003Eampule\u003Cspan style=\"font-family: inherit;\"\u003E\u0026nbsp;without employing the use of on-line cartridge filters\/filter housing on the machine.\u003C\/span\u003E\u003C\/span\u003E\u003Cspan style=\"font-family: inherit;\"\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.4.2\u0026nbsp;\u0026nbsp;Fill volume of media as per the protocol. (The fill volume of media in units need not equal the fill volume of finished product units, the quantity filled shall be sufficient to wet all the inner surfaces of the unit \u0026amp; to enable an inspection to detect positives.)\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.4.3\u0026nbsp;\u0026nbsp;Filling activity is performed in the filling room (especially the filling zone) under LAF.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.4.4\u0026nbsp;\u0026nbsp;\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2013\/08\/three-consecutive-batches-for-validation.html\" target=\"_blank\"\u003EConsecutive first three runs\u003C\/a\u003E will be validated with sterile media solution.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.4.5\u0026nbsp;\u0026nbsp;Simulate the adverse condition testing of the system (details of adverse conditions given separately in step 6.4) after filling approximately 10,000 units.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.4.6 \u0026nbsp;\u0026nbsp;Filling to be planned in a manner such that the operator covers the activities during the shift change over.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003Ch3\u003E\n6.3 VIAL FILLING MEDIA:\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.1 \u0026nbsp;The media fill run shall be performed for approximately the same duration as required for filling of a normal production batch (approx. 12 hours).\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.2 \u0026nbsp;Batch (media) manufacturing shall be done in the initial hours of the 1st shifts, followed by other processing steps normally followed.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.3 \u0026nbsp;Nitrogen flushing shall not be done during media filling.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.4 \u0026nbsp;The filling of the media to be done in the following sequence-\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.4.1\u0026nbsp; The media (Soybean Casien Digest Madium) batch is manufactured in the manufacturing area. The bulk is then aseptically filtered into a sterile holding tank (under LAF) in the sterile area. The tank containing the filtered solution is then connected with is sterile silicon pipeline and filling done in vials without employing the use of on-line cartridge filters\/filter housing on the machine and then dosing of sterile lactose in vials.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E6.3.4.2 \u0026nbsp;Transfer the sterile lactose through material airlock into the sterile area and transfer the sterile lactose aseptically into the previously\u0026nbsp;\u003C\/span\u003Esterilized\u003Cspan style=\"font-family: inherit;\"\u003E\u0026nbsp;hopper of the vial filling machine. Three runs will be validated with 250 mg sterile lactose and 5 ml media solution, 500 mg sterile lactose with 5 ml media solution and 1000 mg sterile lactose with 10 ml media solution to validate the weight range from 250 mg to 1000 mg.\u003C\/span\u003E\u003C\/span\u003E\u003Cspan style=\"font-family: inherit;\"\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.4.3 \u0026nbsp;Fill volume of media or weight of Powder as per the protocol. (The fill volume of media filled units need not equal the fill volume of finished product units, the quantity filled shall be sufficient to wet all the inner surfaces of the unit \u0026amp; to enable an inspection to detect positives.)\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.5 \u0026nbsp;Filling activity is performed in the filling room (especially the filling zone) under LAF.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.6\u0026nbsp;\u0026nbsp;Simulate the adverse condition testing of the system (details of adverse conditions given separately in step 6.4) after filling approximately 10,000 units.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.7 \u0026nbsp;Filling to be planned in a manner such that the operator covers the activities during the shift change over.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cbr \/\u003E\n\u003Cga3\u003E\u003C\/ga3\u003E\n\n\u003Ch3\u003E\n6.4 ADVERSE CONDITIONS: (AMPULE\/ VIAL)\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E6.4.1 \u0026nbsp;Filling machine OFF:\u003C\/span\u003E\u003C\/b\u003E F\u003Cspan lang=\"EN-GB\"\u003Eor 60 minutes (The filtered air supply in the filling zone not to be put off. Imitate maintenance activities that are likely to take place during routine filling process, after restarting approx. 1,000 units to be filled)\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E6.4.2 \u0026nbsp;LAF Filtration OFF:\u003C\/span\u003E\u003C\/b\u003E F\u003Cspan lang=\"EN-GB\"\u003Eor 5 minutes (filling to be done when LAF is OFF)\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E6.4.3 \u0026nbsp;Air Handling Units power OFF:\u003C\/span\u003E\u003C\/b\u003E F\u003Cspan lang=\"EN-GB\"\u003Eor 5 minutes (ALL the AHU’s of the sterile and the adjoining areas to be switched OFF, filling to be done when AHU’s are OFF).\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E6.4.4 \u0026nbsp;Total Power OFF for 2 minutes:\u003C\/span\u003E\u003C\/b\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E(ALL the AHU’s of the sterile and the adjoining areas, filling m\/c, LAF’s etc to be switched OFF, after restarting approx. 1,000 units to be filled)\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E6.4.5 \u0026nbsp;Highest (250\u0026nbsp;\u003C\/span\u003Eampule\u003Cspan style=\"font-family: inherit;\"\u003E\/vial min.) speed of machine:\u003C\/span\u003E\u003C\/span\u003E\u003C\/b\u003E\u003Cspan style=\"font-family: inherit;\"\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003Eapprox. 1,000 units to be filled\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E6.4.6 \u0026nbsp;Change in tubing’s:\u003C\/span\u003E\u003C\/b\u003E A\u003Cspan lang=\"EN-GB\"\u003Epprox. 1,000 units to be filled \u0026nbsp;\u0026nbsp;\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E6.4.7 \u0026nbsp;\u003C\/span\u003EAmpule\u003Cspan style=\"font-family: inherit;\"\u003E\/Vial Sterilizing tunnel OFF:\u003C\/span\u003E\u003C\/span\u003E\u003C\/b\u003E\u003Cspan style=\"font-family: inherit;\"\u003E F\u003C\/span\u003E\u003Cspan lang=\"EN-GB\" style=\"font-family: inherit;\"\u003Eor 5 minutes (total power supply of the tunnel is to be switched OFF, after restarting tunnel all the units from the cooling zone to be filled).\u003C\/span\u003E\u003Cspan style=\"font-family: inherit;\"\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Ch3\u003E\n6.5 STORAGE OF FILLING UNITS (AMPULE\/VIAL)\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.5.1\u0026nbsp; Collect all units in a tray or suitable container, Store in previously maintained temperature defined area or incubator.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.5.2 \u0026nbsp;First Store at temperature 20 -25 ° C for seven days.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.5.3 \u0026nbsp;After that Store at temperature 30 -35 ° C for seven days.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cbr \/\u003E\n\u003Cga4\u003E\u003C\/ga4\u003E\n\n\u003Ch3\u003E\n6.6 RESULT\u003C\/h3\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E1. After the incubation period of the media-filled containers, they are visually examined for microbial growth. Contaminated containers should be examined for evidence of container\/closure damage which might compromise the integrity of the packaging system. Damaged containers should not be included as failures (positives) when evaluating results.\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E2. The number of containers used for media fills should be sufficient to enable a valid evaluation. For small batches, the number of containers for media fills should at least equal the size of the product batch. The target should be zero growth and the following should apply:\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv class=\"MsoNormal\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E•\u0026nbsp; When filling fewer than 5000 units, no contaminated units should be detected.\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E•\u0026nbsp; When filling 5,000 to 10,000 units,\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003Ea) One (1) contaminated unit should result in an investigation, including consideration of a repeat media fill;\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003Eb) Two (2) contaminated units are considered cause for revalidation, following an investigation.\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E•\u0026nbsp; When filling more than 10,000 units:\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003Ea) \u0026nbsp;One (1) contaminated unit should result in an investigation;\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003Eb) \u0026nbsp;Two (2) contaminated units are considered cause for revalidation, following an investigation.\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003EAbstracted from:\u003Cspan class=\"apple-converted-space\"\u003E\u0026nbsp;\u003C\/span\u003EPIC 007-5 dated 01 July 2009\u003Cspan class=\"apple-converted-space\"\u003E\u0026nbsp;\u003C\/span\u003ERecommendation on the Validation of aseptic processes\u003Cb\u003E.\u003C\/b\u003E\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cbr \/\u003E\n\u003Cga5\u003E\u003C\/ga5\u003E\n\n\u003Ch3\u003E\n6.7 DESTRUCTION OF MEDIA:\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.7.1 \u0026nbsp;After 14 days media shall be destructed as per sop or procedure.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Ch3\u003E\n6.8 FREQUENCY OF MEDIA FILLS (AMPULE\/VIAL):\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.8.1 \u0026nbsp;Initial Three consecutive Successful Run(all container size employed for filling on the machine) before start production for qualified area or equipment.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.8.2 \u0026nbsp;Then after once in 6+1 month of Single run any suitable volume for re-qualification of area or equipment.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.8.3 \u0026nbsp;If any change or modification of critical equipment or area then goes for single run media for any suitable volume before starting production.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.8.4 \u0026nbsp;If critical equipment or area is not in use for about one month then go for single run media for any suitable volume before starting production.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E6.8.5 \u0026nbsp;As and when required.\u003C\/span\u003E\u003C\/span\u003E\u003Cspan lang=\"HI\" style=\"font-family: \u0026quot;calibri\u0026quot; , sans-serif;\"\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cbr \/\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003EAlso see:\u0026nbsp;\u003C\/span\u003E\u003C\/span\u003E\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2011\/01\/media-fill-test.html\" target=\"_blank\"\u003EMedia Fill Validation Test in Sterile Pharmaceuticals\u003C\/a\u003E\u003Cbr \/\u003E\n\u003Cbr \/\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/2344258421139798915\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2011\/08\/aseptic-filling-process-media-fill.html#comment-form","title":"18 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/2344258421139798915"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/2344258421139798915"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2011\/08\/aseptic-filling-process-media-fill.html","title":"Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/1.bp.blogspot.com\/-f45IK4CqRZs\/VpFWiF_l0WI\/AAAAAAAAFEA\/qijJPPRrKkI\/s72-c\/media-fill.jpg","height":"72","width":"72"},"thr$total":{"$t":"18"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-8659395280703549295"},"published":{"$t":"2023-09-11T21:48:00.000+05:30"},"updated":{"$t":"2023-09-11T21:48:49.460+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Cleaning Validation"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Validation"}],"title":{"type":"text","$t":"NOEL and MACO Calculations in Cleaning Validation"},"content":{"type":"html","$t":"\u003Cdiv dir=\"ltr\" style=\"text-align: left;\" trbidi=\"on\"\u003E\n\u003Cdiv class=\"MsoNormal\" style=\"margin-bottom: 0.0001pt;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003ENOEL is “No Observed Effect Level” of any pharmaceutical drug. It is determined\nto calculate the MACO (Maximum Allowable Carry Over) in \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2011\/02\/cleaning-validation.html\" target=\"_blank\"\u003Ecleaning validation\u003C\/a\u003E. NOEL\nis the amount of drug in mg that does not have any effect on the human health.\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2015\/01\/NOEL-and-MACO-calculations-in-cleaning-validation.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/8659395280703549295\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2015\/01\/NOEL-and-MACO-calculations-in-cleaning-validation.html#comment-form","title":"13 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/8659395280703549295"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/8659395280703549295"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2015\/01\/NOEL-and-MACO-calculations-in-cleaning-validation.html","title":"NOEL and MACO Calculations in Cleaning Validation"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/1.bp.blogspot.com\/-YNEFp9ksAp8\/VKlx_-XspkI\/AAAAAAAAECI\/UFZM09F5eNw\/s72-c\/cleaning-validation-sampling.jpg","height":"72","width":"72"},"thr$total":{"$t":"13"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-5893323547305077773"},"published":{"$t":"2023-09-03T11:21:00.000+05:30"},"updated":{"$t":"2023-09-03T11:21:54.538+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Validation"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Water"}],"title":{"type":"text","$t":"Purified Water System Validation"},"content":{"type":"html","$t":"\u003Cdiv dir=\"ltr\" trbidi=\"on\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\nWater system validation (generation and distribution) should contain three phases: Phase I: investigation phase; Phase II: short-term control; and Phase III: long-term control.\u003C\/div\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cbr \/\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\nThe objective of pharmaceutical water system validation during these three phases should demonstrate that water system is under control and producing the specified quality of water over a long time period.\u003C\/div\u003E\n\u003Cbr \/\u003E\u003Cga1\u003E\u003C\/ga1\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003ERelated: \u003C\/span\u003E\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2013\/07\/reverse-osmosis-water-purification-system.html\" style=\"font-family: inherit;\" target=\"_blank\"\u003EReverse Osmosis System for Water Purification\u003C\/a\u003E\u003C\/div\u003E\n\u003C\/span\u003E\n\u003Ch2 style=\"text-align: justify;\"\u003E\nCommissioning of purified water system\u003C\/h2\u003E\n\u003Cdiv style=\"mso-layout-grid-align: none;\"\u003E\n\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2012\/07\/purified-water-system-validation.html\" style=\"clear: right; float: right; margin-bottom: 1em; margin-left: 1em; text-align: justify;\"\u003E\u003Cimg alt=\"Water System Qualification\" border=\"0\" height=\"242\" src=\"https:\/\/1.bp.blogspot.com\/-x6Btx3VJjzU\/VpZ7wBj18nI\/AAAAAAAAFGs\/DraOT4m9rLc\/s200\/Water-System.jpg\" title=\"Purified Water System Validation in Pharmaceuticals\" width=\"250\" \/\u003E\u003C\/a\u003E\u003Cspan style=\"font-family: inherit;\"\u003E\u003C\/span\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003EProper documentation of commissioning is an essential part of the successful validation of pharmaceutical water system. Commissioning includes the startup of the water system with documenting the performance of all system parameters.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003Ch2 style=\"text-align: justify;\"\u003E\nQualification\u003C\/h2\u003E\n\u003Cdiv style=\"mso-layout-grid-align: none;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2011\/06\/purified-water-system.html\" target=\"_blank\"\u003EPurified water\u003C\/a\u003E, \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2010\/12\/who-water-for-pharmaceutical-use.html\" target=\"_blank\"\u003Ewater for pharmaceutical use\u003C\/a\u003E, \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2013\/01\/water-for-injection-wfi-system.html\" target=\"_blank\"\u003Ewater for injection\u003C\/a\u003E systems can directly affect the quality of our pharmaceutical products. Hence, it should be validated. Before starting the validation, water system\u0026nbsp;\u003C\/span\u003Equalification\u0026nbsp;\u003Cspan style=\"font-family: inherit;\"\u003Eshould be completed i.e. design qualification (DQ), installation qualification (IQ) and operational qualification (OQ).\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003Cdiv style=\"mso-layout-grid-align: none;\"\u003E\n\u003Ch3 style=\"text-align: justify;\"\u003E\nPhase I:\u003C\/h3\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003EWater sampling and testing should be done for 2 to 4 weeks to monitor the water system. During this phase, water system should operate continuously without failure. Following things should be considered during this phase.\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"text-indent: -0.25in;\"\u003E• \u0026nbsp;\u003C\/span\u003E\u003Cspan style=\"font-family: inherit; text-indent: -0.25in;\"\u003ESampling and testing of the raw water i.e. feed water should be done to monitor its quality.\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"text-indent: -0.25in;\"\u003E• \u0026nbsp;\u003C\/span\u003E\u003Cspan style=\"font-family: inherit; text-indent: -0.25in;\"\u003ESampling after each step should be done daily.\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"text-indent: -0.25in;\"\u003E• \u0026nbsp;\u003C\/span\u003E\u003Cspan style=\"font-family: inherit; text-indent: -0.25in;\"\u003EChemical and microbiological testing should be done as per the approved \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2011\/08\/purified-water-specification-as-per-ip.html\" target=\"_blank\"\u003Especification\u003C\/a\u003E.\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"text-indent: -0.25in;\"\u003E• \u0026nbsp;\u003C\/span\u003E\u003Cspan style=\"font-family: inherit; text-indent: -0.25in;\"\u003EOperating, cleaning, sanitizing and maintenance procedures should be finalized during this phase.\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"text-indent: -0.25in;\"\u003E• \u0026nbsp;\u003C\/span\u003E\u003Cspan style=\"font-family: inherit; text-indent: -0.25in;\"\u003EEnsure the production of the required quantity of water.\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"text-indent: -0.25in;\"\u003E• \u0026nbsp;\u003C\/span\u003E\u003Cspan style=\"font-family: inherit; text-indent: -0.25in;\"\u003EAlert and action limits should be verified after this phase.\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003Cbr \/\u003E\u003Cga2\u003E\u003C\/ga2\u003E\nRelated: \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2013\/07\/pathogenic-bacteria-removal-wfi-purified-water-system.html\"\u003EHow to Remove Pathogenic Bacteria from Water System\u003C\/a\u003E\u003Cdiv style=\"mso-layout-grid-align: none;\"\u003E\n\u003Ch3 style=\"text-align: justify;\"\u003E\nPhase II:\u003C\/h3\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003EA 2 to 4 week testing should\u003Cb style=\"mso-bidi-font-weight: normal;\"\u003E \u003C\/b\u003Ebe done again in phase II to monitor the water system intensively. Sampling frequency shall remain as per the previous phase. Water can be used for manufacturing during this phase of water validation.\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003EThe demonstration should be done that the water system is producing the required quality and quantity of water while operated according to the relevant SOP.\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003Cdiv style=\"mso-layout-grid-align: none;\"\u003E\n\u003Ch3 style=\"text-align: justify;\"\u003E\nPhase III:\u003C\/h3\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003EAfter the successful completion of phase II, phase III runs for one year. We can use water for manufacturing during this phase.\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"text-indent: -0.25in;\"\u003E• \u0026nbsp;\u003C\/span\u003E\u003Cspan style=\"font-family: inherit; text-indent: -0.25in;\"\u003EThe frequency of sampling and testing should be reduced in this phase after successful completion of phase I\u0026amp;II.\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"text-indent: -0.25in;\"\u003E• \u0026nbsp;\u003C\/span\u003E\u003Cspan style=\"font-family: inherit; text-indent: -0.25in;\"\u003ESeasonal variations are observed in this phase of validation i.e. seasonal \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2011\/07\/sop-for-statistical-study-for-trend.html\" target=\"_blank\"\u003Etrending\u003C\/a\u003E shall be done.\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003Cdiv class=\"MsoNormal\" style=\"margin: 0in 0in 0pt;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cbr \/\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\nAlso see:\u0026nbsp;\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2012\/09\/pharmaceutical-water.html\" target=\"_blank\"\u003EPharmaceutical Water\u003C\/a\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\n"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/5893323547305077773\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2012\/07\/purified-water-system-validation.html#comment-form","title":"10 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/5893323547305077773"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/5893323547305077773"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2012\/07\/purified-water-system-validation.html","title":"Purified Water System Validation"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/1.bp.blogspot.com\/-x6Btx3VJjzU\/VpZ7wBj18nI\/AAAAAAAAFGs\/DraOT4m9rLc\/s72-c\/Water-System.jpg","height":"72","width":"72"},"thr$total":{"$t":"10"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-6225246719445608228"},"published":{"$t":"2023-09-01T11:23:00.000+05:30"},"updated":{"$t":"2023-09-03T11:23:25.272+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Validation"}],"title":{"type":"text","$t":"Process Validation in Pharmaceutical Manufacturing"},"content":{"type":"html","$t":"\u003Cdiv dir=\"ltr\" trbidi=\"on\"\u003E\n\u003Cdiv closure_uid_fx5m4r=\"429\"\u003E\n\u003Ch2 style=\"text-align: justify;\"\u003E\n1. Introduction\u003C\/h2\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003EValidation is an essential part of \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2012\/08\/current-good-manufacturing-practice-cgmp.html\" target=\"_blank\"\u003Egood manufacturing practices (GMP)\u003C\/a\u003E. It is, therefore, an element of the quality assurance programme associated with a particular product or process. The basic principles of quality assurance have as their goal the production of products that are fit for their intended use.\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003EThese principles are as follows:\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E• Quality, safety and efficacy must be designed and built into the product.\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E• Quality cannot be inspected or tested into the product.\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E• Each critical step of the manufacturing process must be validated. Other steps in the process must be under control to maximize the probability that the finished product consistently and predictably meets all quality and design specifications.\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cbr\u003E\u003C\/span\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2010\/12\/validation.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/6225246719445608228\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2010\/12\/validation.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/6225246719445608228"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/6225246719445608228"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2010\/12\/validation.html","title":"Process Validation in Pharmaceutical Manufacturing"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/3.bp.blogspot.com\/-fu6ZydTMcqk\/WoLxlrC6sNI\/AAAAAAAAHLs\/klZNSlEVrB0TDU3AmcgfOxn5MNBo16Z1wCLcBGAs\/s72-c\/process-validation.jpg","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-962459546673411667"},"published":{"$t":"2023-08-30T11:22:00.000+05:30"},"updated":{"$t":"2023-09-03T11:22:51.672+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Quality Assurance"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Validation"}],"title":{"type":"text","$t":"Purpose of Process Validation in Pharmaceuticals"},"content":{"type":"html","$t":"\u003Cdiv dir=\"ltr\" trbidi=\"on\"\u003E\n\u003Cdiv style=\"mso-layout-grid-align: none;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003EThe kind of effort expended for \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2010\/12\/validation.html\" target=\"_blank\"\u003EProcess Validation\u003C\/a\u003E is largely determined by organizational structure. Whether Process Validation is managed by a department, a consultant, or a committee, the criteria for the program are still the same. These criteria will be examined by the responsible individuals so that the program will be tailored to the character of the process under study. The following questions are recommended in developing a \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2013\/11\/process-validation-sample-protocol.html\" target=\"_blank\"\u003Esuitable validation protocol\u003C\/a\u003E or plan.\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003Cdiv style=\"mso-layout-grid-align: none;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cbr\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003Cga1\u003E\u003C\/ga1\u003E \n\u003Cb\u003E1. What is being validated?\u003C\/b\u003E\u003Cbr\u003E\n\u003Cdiv style=\"mso-layout-grid-align: none;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003EThe answer to this question is important because it is essential that the objectives of the validation activity be clearly stated. This understanding will enable the responsible group to plan the protocol and the test program needed to carry out the validation program. Quality assurance requires that the total \u003Cspan style=\"mso-bidi-font-weight: bold;\"\u003EProcess Validation\u003C\/span\u003E document include the following:\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2012\/04\/purpose-of-process-validation-in.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/962459546673411667\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2012\/04\/purpose-of-process-validation-in.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/962459546673411667"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/962459546673411667"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2012\/04\/purpose-of-process-validation-in.html","title":"Purpose of Process Validation in Pharmaceuticals"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/2.bp.blogspot.com\/-oxjV6UyhoOg\/U2afLvWbzDI\/AAAAAAAADM0\/Whp1mTj31vQnauc7jz5mE9tDCh57pbV-ACPcBGAYYCw\/s72-c\/validation.jpg","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-1441448716457213773"},"published":{"$t":"2023-08-27T23:09:00.000+05:30"},"updated":{"$t":"2023-08-27T23:09:45.497+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"HPLC"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Quality Control"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Test"}],"title":{"type":"text","$t":"System Suitability in HPLC Analysis"},"content":{"type":"html","$t":"HPLC, short for \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2012\/12\/high-performance-liquid-chromatography.html\" target=\"_blank\"\u003EHigh-performance liquid chromatography\u003C\/a\u003E is a technique used for separating the components in a mixture. In the HPLC technique, a liquid sample is passed over an absorbent material to test its efficacy.\u003Cbr\u003E\nHPLC chromatography technique is used in pharmaceutical industries for research and testing purposes. Most of the pharmaceutical companies follow a three-step approach to check the functioning of their High performance liquid chromatography systems- Initial System Qualification, Method Validation and Suitability Testing (SST).\u003Cbr\u003E\n\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2017\/09\/system-suitability-in-hplc-analysis.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/1441448716457213773\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2017\/09\/system-suitability-in-hplc-analysis.html#comment-form","title":"4 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/1441448716457213773"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/1441448716457213773"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2017\/09\/system-suitability-in-hplc-analysis.html","title":"System Suitability in HPLC Analysis"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/3.bp.blogspot.com\/-q3vbvK3pUx8\/W5ElS-r5NLI\/AAAAAAAAHlg\/M4cRyadNnaY3Pl8TvhzCfQUzYjNSddJhwCLcBGAs\/s72-c\/system-suitability.jpg","height":"72","width":"72"},"thr$total":{"$t":"4"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-3982179477830961465"},"published":{"$t":"2023-08-22T23:30:00.000+05:30"},"updated":{"$t":"2023-08-22T23:30:06.689+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Microbiology"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Sterility"}],"title":{"type":"text","$t":"Difference Between Dynamic and Static Pass Box"},"content":{"type":"html","$t":"In pharmaceutical manufacturing industries, pass boxes are normally used to transfer a particular material between two areas generally of different cleanliness levels. The boxes can be said to transfer the materials from a high level of cleanliness to a lower level of cleanliness or vice-versa. The pass boxes while transferring the material, help to prevent air from flowing from one area to another. Pass boxes are made of stainless steel which is powder coated.\u003Cbr\u003E\n\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2017\/10\/difference-between-dynamic-and-static-passbox.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/3982179477830961465\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2017\/10\/difference-between-dynamic-and-static-passbox.html#comment-form","title":"12 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/3982179477830961465"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/3982179477830961465"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2017\/10\/difference-between-dynamic-and-static-passbox.html","title":"Difference Between Dynamic and Static Pass Box"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/2.bp.blogspot.com\/-3c8q5P_AF-0\/WfXvxskd6CI\/AAAAAAAAG7s\/WSS4DCRLd7wm4PgVPQgLUzkXIpHU4z12wCLcBGAs\/s72-c\/pass-box.jpg","height":"72","width":"72"},"thr$total":{"$t":"12"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-3693519148426198797"},"published":{"$t":"2023-08-17T23:03:00.001+05:30"},"updated":{"$t":"2023-08-18T19:33:31.867+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"HPLC"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Quality Control"}],"title":{"type":"text","$t":"Different Types of HPLC Detectors"},"content":{"type":"html","$t":"\u003Cdiv style=\"text-align: justify;\"\u003E\n\u003Cspan class=\"nanospell-typo-disabled\" data-cke-bogus=\"true\"\u003EHPLC\u003C\/span\u003E detectors are used in the detection of the solute present in the \u003Cspan class=\"nanospell-typo\" data-cke-bogus=\"true\"\u003Eeluent\u003C\/span\u003E coming from the \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2016\/01\/different-types-of-columns-used-in-hplc.html\" target=\"_blank\"\u003E\u003Cspan class=\"nanospell-typo\" data-cke-bogus=\"true\"\u003EHPLC\u003C\/span\u003E column\u003C\/a\u003E. They are capable of determining the identity and concentration of \u003Cspan class=\"nanospell-typo\" data-cke-bogus=\"true\"\u003Eeluting\u003C\/span\u003E compounds in the \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2011\/07\/guideline-for-preparation-of-mobile.html\" target=\"_blank\"\u003Emobile phase\u003C\/a\u003E. There are specific detectors which respond to a specific compound and their response is not dependent on mobile phase composition.\u003C\/div\u003E\n\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2016\/01\/different-types-of-hplc-detectors.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/3693519148426198797\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2016\/01\/different-types-of-hplc-detectors.html#comment-form","title":"2 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/3693519148426198797"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/3693519148426198797"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2016\/01\/different-types-of-hplc-detectors.html","title":"Different Types of HPLC Detectors"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/4.bp.blogspot.com\/-RJSu6XctCcs\/Vq3GkjR_p4I\/AAAAAAAAFLk\/QbRXS2Rr4rk\/s72-c\/hplc-dectector.jpg","height":"72","width":"72"},"thr$total":{"$t":"2"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-4133961966045345479"},"published":{"$t":"2023-08-08T22:36:00.000+05:30"},"updated":{"$t":"2023-08-08T22:36:51.112+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"GDP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GLP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"}],"title":{"type":"text","$t":"Concept of GxP in Pharmaceuticals"},"content":{"type":"html","$t":"\u003Cdiv style=\"text-align: justify;\"\u003E\nOne of the biggest concerns that the pharmaceutical industry constantly attempts to address is the safety of its products. GxP is a collection of regulations that aim to resolve this matter in a systematic and wholesome manner. The concept of GxP requirements in Pharmaceuticals was established by the United States Food and Drug Administration. The term itself encircles many different regulations in many different fields. What is GxP? The G stands for \u0026quot;Good\u0026quot; and the P stands for \u0026quot;Practice\u0026quot;. The \u0026#39;X\u0026#39; in the middle is a variable that can be substituted with any word that appropriately completes the acronym.\u003Cbr\u003E\n\u003C\/div\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2017\/01\/concept-of-gxp-in-pharmaceuticals.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/4133961966045345479\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2017\/01\/concept-of-gxp-in-pharmaceuticals.html#comment-form","title":"3 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/4133961966045345479"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/4133961966045345479"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2017\/01\/concept-of-gxp-in-pharmaceuticals.html","title":"Concept of GxP in Pharmaceuticals"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/1.bp.blogspot.com\/-GsDfucCdffM\/WGkg2Xtr11I\/AAAAAAAAF0U\/aXIPjPkvuF0xoB6GtB4Ih9ykUJzfDbJQQCLcB\/s72-c\/GxP.jpg","height":"72","width":"72"},"thr$total":{"$t":"3"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-4167202282650972442"},"published":{"$t":"2023-08-01T22:39:00.000+05:30"},"updated":{"$t":"2023-08-01T22:39:21.780+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Engineering"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Microbiology"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Sterile"}],"title":{"type":"text","$t":"Smoke Study in Cleanroom Areas"},"content":{"type":"html","$t":"The smoke study also known as dynamic air visualization study is the key qualification, maintenance and monitoring of facility to ensure the final product is free from \u003Ca href=\"https:\/\/www.pharmaguideline.com\/2018\/06\/prevention-of-microbial-contamination-in-manufacturing.html\" target=\"_blank\"\u003Econtamination\u003C\/a\u003E in a processing company. The smoke study in cleanroom area is conducted to visually confirm unidirectional airflow exiting \u003Ca href=\"https:\/\/www.pharmaguideline.com\/2012\/03\/high-efficiency-particulate-air-hepa.html\" target=\"_blank\"\u003EHigh Efficiency Particulate Air\u003C\/a\u003E (HEPA) or Ultra Low Particulate Air (ULPA) filters in a manufacturing clean room.\u003Cbr\u003E\n\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2018\/09\/smoke-study-in-cleanroom-area.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/4167202282650972442\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2018\/09\/smoke-study-in-cleanroom-area.html#comment-form","title":"1 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/4167202282650972442"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/4167202282650972442"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2018\/09\/smoke-study-in-cleanroom-area.html","title":"Smoke Study in Cleanroom Areas"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/2.bp.blogspot.com\/-TKXUhKJhj8Y\/W5lQqqrom8I\/AAAAAAAAHmc\/V4XjNw4ss1gMYwOoMrdYM-b3TCZKVEnMwCLcBGAs\/s72-c\/smoke-test.jpg","height":"72","width":"72"},"thr$total":{"$t":"1"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-1340965322566948160"},"published":{"$t":"2023-07-24T10:39:00.000+05:30"},"updated":{"$t":"2023-07-24T10:39:54.524+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Engineering"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Production"}],"title":{"type":"text","$t":"Different Types of Stainless Steel for Pharmaceuticals"},"content":{"type":"html","$t":"\u003Cdiv dir=\"ltr\" style=\"text-align: left;\" trbidi=\"on\"\u003E\n\u003Cdiv class=\"MsoNormal\" style=\"margin-bottom: 0.0001pt;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\nThere are different grades of stainless steel according to the composition like 302, 304, 304L, 316, 316L, 410, 430, 440 etc. but all are not used in pharmaceutical. \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2010\/12\/qualification-of-systems-and-equipment.html\" target=\"_blank\"\u003EPharmaceutical equipment\u003C\/a\u003E is made of the material that should not react with the active material or excipients used in pharmaceutical manufacturing.\u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2015\/02\/different-types-of-stainless-steels-in-pharma.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/1340965322566948160\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2015\/02\/different-types-of-stainless-steels-in-pharma.html#comment-form","title":"2 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/1340965322566948160"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/1340965322566948160"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2015\/02\/different-types-of-stainless-steels-in-pharma.html","title":"Different Types of Stainless Steel for Pharmaceuticals"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/2.bp.blogspot.com\/-oxrMJyC3kTA\/VNedidErhyI\/AAAAAAAAEH4\/5JKmYadEBqY\/s72-c\/SS-Scoop.jpg","height":"72","width":"72"},"thr$total":{"$t":"2"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-8777489088704683109"},"published":{"$t":"2023-07-17T09:41:00.000+05:30"},"updated":{"$t":"2023-07-17T09:41:23.492+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Quality Assurance"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Validation"}],"title":{"type":"text","$t":"Hold Time Study in Pharmaceutical Manufacturing"},"content":{"type":"html","$t":"\u003Cdiv dir=\"ltr\" style=\"text-align: left;\" trbidi=\"on\"\u003E\n\u003Cdiv class=\"MsoNormal\" style=\"margin-bottom: 0.0001pt;\"\u003E\n\u003Cdiv style=\"text-align: justify;\"\u003E\nSometimes during manufacturing, the in-process materials need to be held for a period more than usual. Hold time study during manufacturing is the \u003Ca href=\"http:\/\/www.pharmaguideline.com\/2014\/05\/importance-of-validation-in-pharmaceuticals.html\" target=\"_blank\"\u003Evalidation\u003C\/a\u003E of the hold time period of in-process materials. Now hold time study during pharmaceutical manufacturing has more importance because it is now recommended by the World Health Organization (WHO).\u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2015\/06\/hold-time-study-in-pharmaceutical-manufacturing.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/8777489088704683109\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2015\/06\/hold-time-study-in-pharmaceutical-manufacturing.html#comment-form","title":"5 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/8777489088704683109"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/8777489088704683109"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2015\/06\/hold-time-study-in-pharmaceutical-manufacturing.html","title":"Hold Time Study in Pharmaceutical Manufacturing"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/4.bp.blogspot.com\/-N-GgFv8s-0E\/VY_bJ4IFtYI\/AAAAAAAAEaI\/6smTXJsmKZc\/s72-c\/hold-time-sample-containers.jpg","height":"72","width":"72"},"thr$total":{"$t":"5"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-7329410712477867260"},"published":{"$t":"2023-07-07T10:37:00.000+05:30"},"updated":{"$t":"2023-07-07T10:37:22.914+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"GDP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Quality Assurance"}],"title":{"type":"text","$t":"Quality Management System (QMS)"},"content":{"type":"html","$t":"\u003Cspan style=\"background-color: white; color: #333d43; font-family: inherit; font-size: 16px; text-align: justify;\"\u003EOrganizations engaged in the distribution, as well as the storage of materials along with products, should monitor, establish, maintain and implement the aspects of the quality management system that allows the delivery of resources, product and services, and materials with the requisite quality and safety.\u003C\/span\u003E\u003Cbr\u003E\n\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2016\/10\/quality-management-system-qms.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/7329410712477867260\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2016\/10\/quality-management-system-qms.html#comment-form","title":"1 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/7329410712477867260"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/7329410712477867260"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2016\/10\/quality-management-system-qms.html","title":"Quality Management System (QMS)"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/1.bp.blogspot.com\/-SgOokToNL4A\/WBYdgQ2stFI\/AAAAAAAAFnw\/ZVi6o_28R88h6jygHlH4Q4OHRJAQNfQFgCLcB\/s72-c\/QMS.jpg","height":"72","width":"72"},"thr$total":{"$t":"1"}}]}});