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Pharmaceuticals/Raw materials re-test

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Question
I saw you made this affirmation on a previous answer:
The world-wide regulatory acceptable text is:
a. for finished dosage forms - "expiration date"
b. for raw materials (active [API]or excipients) is "retest date"

I would like to know if you can point me to the exact name of the document or the regulation where this is stated like that?

I need to prove to the regulatory entity in Costa Rica that retest of raw materials is an acceptable and valid practice in pharmaceutical industry.

Thank for your help

Answer
Margie:

the definitions of "expiry" and "retest" can be found in many WHO, European Union and PIC/S (Pharmaceutical Inspection Cooperation Scheme) guidelines.

Specifically the definitions can be found in the glossary of: PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE PHARMACEUTICAL INGREDIENTS) PE 009-11 (Part II) Documents for industry PIC/S GMP Guide - downloadable at http://www.picscheme.org/publication.php?id=4

I hope this helps

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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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