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Pharmaceuticals/Reg : Validation batches

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Expert: Michael Anisfeld - 6/14/2007


Question
I would like to know whether validation batches can be sold in the local market or is it compulsory to destroy the same after completion of periods.

Please refer  USFDA & Indian FDA norms in this regard

Answer
In the USA - if all the validation batches (a minimum of 3) pass all the protocol criteria, the validation report has been reviewed and approved by QA, and the product has been approved by FDA, then the validation batches can be sold.

In India - colleagues tell me, that the same situation applies.

Best Regards

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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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