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Pharmaceuticals/Requirement for reserve samples of APIs

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Question
Dear Anisfeld-san,

Your kindness is always appreciated.

Could you interpret the requirement for reserve samples of APIs in the U.S.?
Although 21 CFR211.170 (a) does not require the annual visual examination, COMPLIANCE PROGRAM GUIDANCE MANUAL (7356.002F) mentions the  documentation of reserve samples examination.

Thank you in advance.

Best regards,
Ryota

Answer
The regulations require you to keep reserve samples (equivalent to performing all testing x2). The CPGM elaborates that as well as keeping the samples, you need to visually inspect them annually(and to record the results of the visual inspection).

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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