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Pharmaceuticals/Microbiological analysis of Non Sterile Products


I'm in the middle of an small controversy, because i'm not doing microbiological analysis all batches of product, based on the low water activity and a good history of the product. My question is: Am i doing a Bad Manufacture Practice, do need to change and analyse all batches.


Most people perform a microbial analysis of Purified Water on a weekly basis, based on a historical profile that justifies doing so.

Based on the historical profile you will have established "alert" and "action" levels. If a weekly result is above an "alert" level, then sampling becomes daily for typically three or five days from all points of use, and reverts to weekly sampling only if this is justified from this increased sampling schedule. If you go above your action limits, then as well as enhanced daily sampling, from all points of use, you also need to perform system cleaning.

I hope this helps.
Good Luck, Michael Anisfeld


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Michael Anisfeld


Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements


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