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Question
Mike, Hope you are doing fine.
We have to make an OTC product ( deodorant) that has very small production requirement. We plan to conduct 3 stability batches then make 1 production batch which will be considered first process validation batch.

If there is no production requirement until the following year, we are planning to conduct the second process validation batch then and hopefully the 3rd PV by the same year or worse the following year. Assuming the stability batches come out good, at least the accelerated , are we ok to sell the validation batches?

Note that we will be conducting validation batches consecutively only with a few months gap. Need your advise. I think I read it before that it is ok, just cannot find it now. THX. LISA.

Answer
Dear Lisa:

What you are proposing sounds eminently suitable; but please remember that at least one of your stability batches needs to be made on commercial scale equipment, and that each of your three stability batches needs to be manufactured from a different batch foo actives (three batches of actives in total).

So, yes, your plan is good to go, assuming your stability and validation batches come out OK. You can save time/money by having each of your validation batches be your stability batches.

Good Luck.

Pharmaceuticals

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Michael Anisfeld

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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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