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Pharmaceuticals/Retest,best befor and Expairy date for raw material ??


QUESTION: When we receive any raw material that have label or certificate contains one of this word ( Retest date , best before date , re-evaluation date or expiry date )  
i would to now what difference between this words for active and inactive material
and when we stop use this material as this date

and how we can determined the retest date as the date on certificate


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"

Any other wording is that company's own invention and should be considered in the light of the above. You might want to e-mail these companies to ask for their definition (and if you get an answer please advise me - I'd love to know).

Best Regards.

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QUESTION: thank for you

but I want to now if it (retest date ) how much the period we can use this material after this date

example : retest date for calcium carbonate 2\2012 we tested it and it pass

how much the period we can use it after test (1 month , 1 years , 6 month ) and why ???

you understand me ??

ANSWER: The Canadian GMPs state that is a raw material is past its retest date, then you can perform full specification testing and if the material passes, it can be used for the next 30 days.

The Canadians are the ONLY folks who comment on your situation.
I hope this helps.

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QUESTION: thank you Michael Anisfeld

but you can provied me with document for this answer as paper or the position of this answer in Canadian GMPs document

Please I will search for this but if you can help me I will thank you

Here is the text that I was referring to:

"7. Only raw materials that have been released by the quality control department and that are not past their established re-test date or expiry date are used in fabrication.
7.1 If any raw material is held in storage after the established re-test date, that raw material is quarantined, evaluated, and tested prior to use. The re-test date or expiry date is based on acceptable stability data developed under predefined storage conditions or on any other acceptable evidence. A batch of raw material can be re-tested and used immediately (i.e., within 30 days) after the re-test as long as it continues to comply with the specifications and has not exceeded its expiry date. A raw material held in storage after the established expiry date should not be used in fabrication"

If you would like the entire GMP document, please provide me your e-mail address.


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Michael Anisfeld


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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