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Pharmaceuticals/Use of Raw Materials After Re-test / Expiry date

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Question
Referring to your Q/A session on 1/27/2014 on the subject of retest/expiry of raw materials, you said that world-wide acceptable text for raw materials (API & Excipients) is re-test date, not expiry date.
FDA Guidelines also advise the API manufacturers to use retest date instead of expiry date for all raw materials except a few but still there are many raw material manufacturers who are still using the expiry date.

As a medicine manufacturer, in light of the above statement of FDA and WHO, can we still use the material after the declared EXPIRATION Date given that, 1. The re-test protocol determines the Identity and Purity of the given raw material and 2. The stability of that raw material in our own store is established on the basis of our test results?

Answer
The only GMP regulations globally (that I am aware of) that allows for use of raw materials after the labelled retest date is the Canadian GMP regulations.

see http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/gmp-bpf/docs/gui-0 - section 7.1

You will need to check the regulations for the country in which you are marketing your product to definitively answer your question.

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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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