Microbial testing regime
We had our GMP inspection recently, and the inspector noted that we are microbial testing (TAMC & TY&MC) all batches. We outsource this microbial testing. He indicated that this was not necessary. Of course, this contradicts what the previous GMP inspector says. I have followed up this inspector in writing requesting exactly what testing regime would be acceptable, and of course, he offered nothing concrete. His comments (in writing) included:
“It just left to your own risk assesment on how to conduct on microbial limit testing.”
“For me personally as a auditor, I wouln’t be too rigid on the concept that every single batch of cosmetics have to do a thorough microbial limit test. It is always good to consider the necessary step and precautions to make sure the cosmetic product is safe and of quality.”
Now that two subsequent GMP inspectors have contradicted themselves, I would like to implement a microbial testing regime that is (1) scientifically defensible, and (2) at less cost than microbial testing every batch we produce.
My immediate thoughts are that we adopt periodic testing based on a risk assessment and previous results for each product. How often we test, I’m not sure. Any suggestions on an approach we could adopt?
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