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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?
Thanks.
Mike
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9 Replies
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I would keep to the original regime which met with the approval of the more rigorous inspector. Who knows but the next visit may be from this same person (or someone more finicky) who will tell you that your new system is not acceptable.
It seems that you will never get these officials to either agree amongst themselves or commit to anything of importance. They are in the business to enable them to take home a salary. Real knowledge of their job is usually sadly lacking.
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agree with @johnb - I’d stick to the original regime, you can never be too careful when it comes to micro testing
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Have you considered doing microbial strip testing on each and every batch as a quick in-house test and then outsourcing perhaps every 3rd batch of a product?
The strip tests from Schuelke & Mayr are going to be sufficient as an indicator as to whether there is any microbial contamination and whether or not a USP 61 is required. All you need are the strips and a small incubator.
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Yes @MarkBroussard, exactly the line I am now pursuing. Has been difficult to source these types of strip tests here in Malaysia, and will certainly follow up any local agents for Schuelke & Mayr.
Thanks
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I still keep to my original comments here.
You have two officials with differing views and, unless the more strict one has transferred or met his demise, then I would suggest that there is a reasonable chance of another visit from him. This being so, if you have relaxed your diligence in the so far that you have, not only gone against his directions but have introduced a system ( the Schülke & Mayr method) which he may not agree with.
I realise this will be almost impossible to do but it would be strongly in your interest to get an “approved” statement of what the requirements are - and to get and retain hard copies of all that is exchanged between you.
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Yes @johnb I agree “..strongly in your interest to get an “approved” statement of what the requirements are..” and that is exactly what I have done.
The response to my question “Can you please provide clear details of the type of microbial testing regime that would be acceptable?” was:
“Hi Dear Dr Mike Thair,
For the microbial testing, Indeed I did not mention it is not necessary, but indeed if we refer to the Annex 1 (as attached), it is a requirement.
It just left to your own risk assesment on how to conduct on microbial limit testing.
For example: What product most likely demonstrate haviest microbial proliferation during production, is that the cosmetics likely cause side effect on human if the viable count is more than the acceptance limit, the nature properties of the products: As if the product itself is a natural antimicrobial agent, etc..
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
Hope it helps”Currently, I’m in the process of unpackaging exactly what all this means.
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What he means is: “I’m a government official and I will not commit to you in writing any specific protocol as it is a function of the particular product you are manufacturing”
You need to evaluate the risk of microbial contamination and your testing protocol on a product-by-product basis. Some formulations may be more susceptible to microbial contamination than others based on the ingredients, final pH of the product, etc.
Based on your experience to date with the formulas you are manufacturing … study the history of each and see which ones have failed your plate count tests or have been marginal. You may have a more rigid protocol for those formulas that others.
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Hedging around a definitive answer then - guarding his own rearend, you might say.
As I mentioned previously, as there is more than one inspector involved, there is always the danger that the more strict one may re-appear and tell you that what you are doing is all wrong.
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Yes, agree @johnb and @MarkBroussard. Good thing is that we have good results on all the microbial tests to-date (zero fails), including the challenge tests. I will navigate through all of this, apply good science, and come up with a testing protocol that can be defended.
@MarkBroussard have had a win with the Schuelke & Mayr distributor and have ordered a box of these microbial test strips to try out. A quirk of this distributor, however, is that they ship from Europe via sea cargo which takes 3 months, reducing the 9-month shelf life to only 6 months.
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