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Pharmaceuticals/Manufacuring date

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Question
Dear Dr Micheal
Is the manufacturing date considered from the date of dispensing or the date of manufacturing , as MOH inspector ( Egypt )  insist to consider Manuf. date is the dispensing date , we are producing Solid dosage form products , and intend to produce sterile products in the future . is there any reference about this issue

and the second question regarding Expiry date , kindly could you help in Ref. mentioned how expiry date is related to raw material expiry or not related

Thanks and Best Regards
Mohamed Eissa

Answer
Q1:
As far as I am aware, globally, all countries consider the manufacturing date as the date that the drug product ingredients are mixed together; on condition that between dispensing (weighing) and usage in formulation, the weighed material is stored under appropriate conditions.

For tablets this is the date of blending/granulation; for liquid products, this is the date that solvent is added to the formulation tank.

Q2:
Except in India (which has bizarre rules on this), the expiration date of a drug product world-wide has no relationship to the re-test date of the raw materials. Expiration dates for drug products are based on stability studies performed according to ICH guidelines (ICH-Q1 and Q2)


I hope this helps,
Michael Anisfeld

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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