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Pharmaceuticals/IQ/OQ PQ and CV on Equipment used for Trail Runs

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Question
Mr. Anisfeld,

Does production line equipment used to fill and package non-saleable soaps and hand gels require IQ/OQ PQ and CV validations performed if the equipment is being used ONLY for a small batch trial run?


Thanks,

Answer
Dear Steve:

I'm not sure what a "non-saleable soap" is exactly; but if the product is being sold in inter-state commerce, regardless of the batch size, it needs to conform to US cGMPs. In which case, then all the Q's apply.

If the product is not being sold or otherwise commercially distributed (e.g. salesman samples), then Q's do not apply.

I hope this helps.

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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