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Expert: Michael Anisfeld - 7/2/2009


Question
Hello Michael, Have a nice Day
My question is:
Can we give Retesting date to Raw Material beyond its expiry date and for how long? Is there any reference in either case.

Answer
The only GMP providing guidance on this, worldwide, is the Canadian GMPs.

They state that if the retest date is exceeded, then full specification testing must be performed, and the material is shown to meet specification. The raw material need to be used within 30 days of this testing.

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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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