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Pharmaceuticals/Class A with background class C


Dear Dr Michael Anisfeld

for class A with background C ( LAF in compounding area for products to be sterilized ) & ( LAF in dispensing with class D background )   at end samples swaps fail to meet class A limits in viable counts , is it possible to make Risk assessment and raise the Limits
or is there any other limits for such cases , as it is impossible to meet class A limits while the background is not class B and the gowns are for class C

Thanks a lot
Mohamed Eissa

Your question is interesting, but as written is confusing. I assume by stating areas as Classes A, C and D, you are referring to EU GMPs which you are trying to meet.

If the failing sample swabs were taken in the Class A area (working) with either C or D (background), then you have serious problems, as Class A has tight microbial limits.

If the failing sample swabs were taken in the Class C or D (background) areas, then you also have concerns but lesser than if they were found in the Class A (working) area.

Your proposal to change the limits is not legal if you are exporting product to the EU; and is not good practice or acceptable even if you are not exporting to EU countries. What you need to do is perform a thorough root cause analysis, find the problem and resolve it.

I hope this helps.


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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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