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What is method validation and why do only some CMOs require it for OTCs?
I was shopping around for CMOs do to a sunscreen formula, and a minority require “method validation”; typically making 3 batches (that usually can be sold) to somehow validate that they make the product correctly. In the rangeof $5-15k price range on top of the cost of the batch.
Nobody explains why and what in detail what they do, some think it’s a FDA requirement, others don’t.
Is paying $10k for method validation of a sunscreen reasonable when you could just to API and Micro testing of each batch for a much lower cost?
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13 Replies
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As you likely know you do need method validation to run actives as per FDA guidelines but 10K is high (way high).I would have it done myself and provide method to be run as per your guidelines which can be merged with FDA requirements.
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Could you clarify? Do it yourself? What’s wrong with just API and micro testing?
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i think we have have a miscue-define API-I am relating to testing % active sunscreen after addition to batch for which you need a validated method?
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Hi @Zink is your FDA monograph testing complete and accelerated stability? If so, I know a CMO with low minimums that will produce for you.
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It’s complicated, but the short version is that method validation is what proves that your API assay test is accurate for your specific formula. It should be done every time a significant formulation change is made. Without it, you don’t really have proof that you actually have the level of API in your product that your label claims you do, or that your stability tests are accurate.
What’s worse is if an API assay comes back out-of-spec after you’ve already gone into production. Without a validated method, you won’t know if the test was done wrong, or the batch was made wrong.
All this can be avoided by using an already formulated, validated, and stability tested product. A number of CMO’s and private label manufacturers have these ready to go. It’s much, much less aggravating to go this route.
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API = Active Pharmaceutical Ingredient. It is different from the “bulk active” amount, which can have diluents in it.
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@Bobzchemist thank you, so if I understand correctly:
Method validation is a number of test batches that are API assayed to make sure production batches will be meet API spec?
This could be from 1 to X batches and they could be sold if they pass the API testing?
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No method validation is a reliable analytical method for percent API before you produce.
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As I understand it, method validation is a series of API assays, using placebos/knock-outs, which make sure that your formula specifically can be tested and produce accurate assay results. For example, using only 1 API (for simplicity), ideally you’d test 4 batches of your formula - one with no API, one with 100% API, one with 90% API, and one with 110% API. This will prove that the assay used correctly picks up the variations.
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Typically, a method validation is run on lab batches, which cannot be sold.
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Interesting @Bobzchemist I’ve never had it explained that way by CMOs, usually they don’t say what in entails beyond mentioning a series of lab batches of various sizes which usually in my experience can be sold “if they pass the test”.
The majority of CMOs I’ve been in touch with don’t require it at all and are happy with 1 year stability testing w API draws in place and doing per batch API testing (some also want PET and RIPT testing to be done, naturally from their POV the more testing the better).
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What I described is the highest level of method validation, as I’ve had it explained to me, in the context of “why does this cost so much?” How much, if any, validation is done is up to each individual manufacturer.
Everyone’s tolerance for risk is different. I don’t know who’d be on the hook for accurate results during a FDA audit, you or the CMO.
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That’s definitely true, there’s a large range of risk tolerance out there, I don’t think anyone would be on the hook for not doing a bunch of method validation batches if the production batches pass API testing - seems like more of a precaution to make sure production batches turn out as expected?
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