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Pharmaceuticals/Retesting of Inactive materials that needs no microbial testing


QUESTION: I would like to ask about the retesting of Opadry white raw material.It is stated that the re-evaluation date for this material
is 27.03.2013.Please note that this material was analyzed on 25.04.2012 and they give it a retesting date on 25.04.2014.Is it right?what is the best retesting date for this material?Can you help?

ANSWER: If the Opadry manufacturer's retest date is 25.04.2014 then as long as it has been stored in the manufacturer's stated storage conditions, there is no need to retest the Opadry until then.

Where did the 27.03.13 re-evaluation date come from?

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QUESTION: It is stated in the COA of this material that the re-evaluation date is on 27.03.2013.Is it necessary to retest this material on that date?Please note that this material was analyzed and released on 25.04.2012.

If the COA states one retest date, and the label on the container states another, then the COA you are looking at does not relate to the specific Opadry drum (batch) that you are looking at. COA's are always batch specific.

If no other information is available, go with the manufacturer's retest date stated on the Opadry drum (assuming you have maintained the recommended storage conditions).


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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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