Good Automated Manufacturing Practice denoted as GAMP, are guidelines provided for both users of automated pharmaceutical products and manufacturers of these products. GAMP was founded in 1991 by pharmaceutical industry professions in the UK with the aim of addressing the needs of the industry and basically to improve the changing expectations of Europe regulatory agencies and it mainly wanted to provide understanding on how pharmaceutical companies should validate their computer systems.
Mar 19, 2017
Installation Qualification (IQ) is ascertaining that all the important aspects of process equipment together with ancillary system installation follow the approved specification of a manufacturer and what the supplier recommends. An equipment has to be installed by trained personnel according to the drawings and specifications provided. An approved protocol designed by an engineering department is used for performing an IQ. All procedures to do with maintenance, cleaning and calibration are drawn at the installation stage.
Mar 13, 2017
Design qualification is defined as a verification process on the design to meet particular requirements relating to the quality of pharmaceuticals and manufacturing practices. However, the procedure for design qualification in pharmaceuticals is one reason as to why some products do not make it to the shelves in drugstores.
Mar 5, 2017
Your answers to the questions asked in the interview directly affect your selection for the job. Everyone prepares for the job interview and tries to find the question those could be asked in his interview. Some questions are very common those are asked by the interviewers.
Feb 26, 2017
Vendor audits in the pharmaceutical industry may be perceived to be a burden for some vendors and a resource drain for the pharmaceutical companies, they are valuable and necessary processes meant to benefit both. This is especially so when dealing with life-saving medications.
Feb 19, 2017
Telephonic interviews are used by employers as a means to reduce the number of candidates for a face to face interview in order to make sure the best candidates are seen. A number of employers now ask an external agency to carry out this type of interview, especially in the case of graduate recruitment.
Feb 12, 2017
Did you know that it takes an employer a maximum of 7 seconds to go through your Curriculum Vitae? Employers receive numerous CVs for the positions they advertise. For this reason, they do not set aside a lot of time to go through each CV. Therefore, it is very important for you to write a CV that will not only make you stand out within the 7 seconds but also push the employer to contact you. Would you like to know how to write a good CV? If so, below are some tips that will help you write a powerful CV.
Feb 5, 2017
Finding a well-paying job after pursuing a course in pharmaceutical is not easy. There are many people who have tarmacked for years looking for a good job in this field but all has been in vain. If you are among this group then you should ask yourself a number of questions before going for the next interview. Passing a pharmaceuticals interview should not be a nightmare on your part. There are different things you have to do before, during and after the interview if at all you would like to secure a job.
Jan 29, 2017
Good Manufacturing Practice (GMP) is a process that ensures that products that are produced by pharmaceutical companies are of quality standards. The GMP is incorporated in the system of production and this result in the minimization or elimination of risks of the final products produced. GMP is integrated into all sequences of production from the raw materials, the premises design, to the equipment used. Also, the personnel training and hygiene are promoted since it is the principle contributor to GMP. Detailed and documented procedures are vital for the finished pharmaceutical products to be of quality.
Jan 22, 2017
The surprising truth is that there are billions of micro-organisms circulated in the air most of which are bacteria in nature but the biggest problem is one, identifying them seems to be one of the most major mountains to climb. Many of the pharmaceutical laboratories have tried to identify them through air sampling methods, but quite often results have shown that there are other sources of environmental isolates that are contaminated with pharmaceutical products and others microorganisms in water.
Jan 15, 2017
The Bacterial Endotoxins Test is an invitro test that is usually carried out when one is keen to identify whether there are endotoxins. Endotoxins are also commonly known as pyrogens and they are mainly produced by gram negative bacteria. The principle of Bacterial Endotoxin Test makes it the most sensitive test that one can use to detect and quantify endotoxins, toxins that are famously known for causing fever in humans. Pharmaceutical products can be contaminated during purification, production or packaging stages, and the Bacterial Endotoxin Test is used to confirm that the products are not contaminated before they are administered for use in humans.
Jan 8, 2017
One 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 in Pharmaceuticals was established by the United States Food and Drug Administration.The term itself encircles many different regulations in many different fields. The G stands for "Good" and the P stands for "Practice". The 'X' in the middle is a variable that can be substituted with any word that appropriately completes the acronym. For example, 'x' is replaced by 'M' to make it GMP which represents 'Good Manufacturing Practice'. GxP extends to many regulated industries such as cosmetics and food as well besides pharmaceuticals. Regulators for GxP are spread out throughout the World. Some of the popular regulators include FDA in the US, TGA in Australia and HS-SC in Canada.
Jan 1, 2017
Titrimetry, or in more general terms titration is a process which is carried out to analyze an unknown compound in order to determine the concentrations of various substances present in it. It is a well-known method used in laboratories for the sole purpose of quantitative and qualitative estimation of a particular chemical substance.
Dec 25, 2016
The floor coatings of companies manufacturing medicinal drugs should manage to resist most oils, acids, and solvents. Also, the coating must be resistant to abrasion and impact since the plant’s floors could easily be exposed to heavy traffic from hefty tools and machinery. A type of floor coating that can surely offer durable and hard wearing solutions is the epoxy flooring. This type of floor coating can be applied over concrete floors to ensure a high performance as well as an attractive surface.
Dec 18, 2016
To keep the controlled area from being contaminated in pharmaceuticals, two processes namely fumigation and fogging are used. Both the processes are used for the same purpose, but the difference between fumigation and fogging in pharmaceuticals is great. Moreover, fumigation is banned in few pharmaceuticals because of its negative effects while fogging is a safer option than the former.
Dec 11, 2016
Facing FDA inspection is being critical day by day because FDA is inspecting pharmaceutical units at very short notice period. This makes it critical because of having a short period for preparation. FDA is doing this because they want to develop a quality culture in pharmaceutical firms instead of a culture where quality is maintained before inspection.