How to implement Good Documentation Practices
In a pharmaceutical or healthcare GMP environment, implementation of Good documentation practices is very much required as it is directly affecting the product quality, safety, efficacy. If any document related…
HPLC Troubleshooting & Its Data Integrity Assessment
HPLC (High Performance Liquid Chromatography) is a chromatographic technique used to separate a mixture of compounds between Mobile phase and stationary phase. The technique is widely used in industrial area…
Handling of consumables in pharmaceutical industries
If I am talking about material management system, we do all the thing to comply the regulatory requirement; Raw material supplier qualification, raw material technical evaluation, testing etc. but to…
Technology Transfer Procedure
PROCEDURE ON TECHNOLOGY TRANSFER Objective of this procedure is to provide a guideline on the transfer of technology from R&D to manufacturing site and from one manufacturing site to another manufacturing…
Microbial Contamination in Pharmaceutical products
What is Microbes?The microorganism or microbes is a microscopic organism which may exist in single celled form or in a colony. Single celled microorganism were in the first form of…
Disinfectant validation and its significance in pharmaceutical industries
There are number of products which are recalled from the market just because of contamination issue. Now, here are more Question come into mind; Where did it contamination came from ? How…
How to prepare User Requirement Specification
URS mean User Requirement Specification is a first document to define the procedure for the procurement of any equipment. Generally people make lot of mistake during preparation of user requirement…
Procedure for handling of Regulatory Audit
From the business point of view every regulatory audit is important for any pharmaceutical facility and handling of regulatory audit is an art and its required lots of preparation so…
Process alarm and Its significance during pharmaceutical product manufacturing
Process alarm are those alarms which are generally generated during any processing like manufacturing, packaging, utilities operation and each alarm generate with some reason which have some significance on the…
Common Mistakes During Failure Investigation
Definitely you have encountered anytime with failure and you have done the investigation. If you see the FDA 483 and MHRA observation then you will find most of the observations…