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Pharmaceutical Guidelines


Aug 28, 2016

Importance of Blend Uniformity in Manufacturing Process


Blend uniformity is an important factor in pharmaceutical manufacturing. A poor uniformity of the blend can cause the rejection of the product that can lead to the loss of revenue.

Aug 21, 2016

Why Firms Must Avoid FDA 483 and Warning Letters?


FDA has the mandate of ensuring the safety of the public by assuring the safety of drugs and medical devices among others. To this end, FDA officials occasionally visit manufacturing establishments for the purpose of carrying out an inspection to find out whether or not the establishment is in compliance. After an inspection, FDA officials may issue FDA 483 and warning letters. Sometimes, the manufacturer may receive an FDA 483 form without a warning letter.
Aug 14, 2016

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing


Both of these techniques are used to manufacture sterile pharmaceutical products as parenteral (LVP & SVP), infusions, ophthalmic and inhalation products. These are automated techniques to prepare sterile products.
Aug 7, 2016

Requirements for Good Documentation Practice (GDP)


Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document.
Jul 31, 2016

Acceptable Quality Level (AQL) in Pharmaceuticals


Acceptable Quality Level is a sampling plan according to the batch size and inspection levels. Some buyers have this requirement to follow the AQL therefore some manufacturing units have started following this concept in pharmaceuticals.
Jul 24, 2016

Procedure for Sampling in Process Validation


Sampling plays a major role in achieving the accurate results of analysis. Sampling plan and procedure must be defined in validation protocols and training should be provided to the concerned staff before the validation activity starts.

Jul 17, 2016

Preparation of MFR for Pharmaceuticals


Master formula record (MFR) is a master document for any pharmaceutical product. It contains all information about the manufacturing process for the product. MFR is prepared by the research and development team of the company and all other documents like BMR and BPR are prepared using MFR by the manufacturing units.
Jul 10, 2016

Human Generated Contamination in Cleanroom and its Control


Cleanroom contamination is a major problem in sterile manufacturing and it is difficult to maintain the cleanroom area. People working area are the major source of contamination.
Jul 3, 2016

Can you Switch off HVAC System in Night?


Maintenance of clean room area is very expensive. It is a common question that everyone wants to ask that can we switch off our HVAC systems in night to save the power consumption?
Jun 26, 2016

Tips to Develop Equipment Cleaning Procedure


A well developed cleaning method is a primary requirement of the cleaning validation. Cleaning procedure should be developed before starting the cleaning validation. Following things should be considered during development of good cleaning procedure.
Jun 19, 2016

Lux and Light Intensity for Pharmaceutical Areas


Sufficient light is necessary at work place to get better work output. Less lighting in working area can result errors in different ways. None should experience eye-strain during his work.

Jun 12, 2016

4 Tips to Reduce 483 Observations


483 is a FDA form that is issued to report the GMP inspection observation by FDA officials. It contains all objectionable activities found by the FDA inspector during the inspection of a manufacturing facility.
Jun 5, 2016

Is Fungal Count Acceptable in Pharmaceutical Classified Area?


Classified area is monitored for viable and non-viable particles in pharmaceutical manufacturing. Fungus and bacteria both are found in the environment. Both are determined by the air sampling using the growth medium by settle plate and active air sampling methods.
May 29, 2016

6 Ways to Reduce Human Errors in Pharmaceuticals


Human 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.
May 22, 2016

Role and Calculation of Air Changes per Hour in Clean Room Area


Air changes in pharmaceutical clean room play an important role in maintenance of HVAC clean room quality. Air changes per hour are the number of total replacements of any room’s air in one hour.
May 15, 2016

Validation of Fumigation in Cleanroom Area


Fumigation is the process to disinfect the sterile manufacturing and microbiology testing area. Generally fumigation is not required when AHU runs continuously but when the microbial load increases in the controlled area it is controlled and minimized by fumigation of the area.