Pharmaceuticals/Raw material


If i have raw material the life time six more months.example I buy raw material the date is 3 January 2014 and expired date of the raw material 12 July 2014. Could I use for production and how many the life time of the Finished product
Thank you

Dear Tri:

Besides asking the obvious question of why you would purchase a raw material with only a six month shelf life, the answer to your question is:

Except for India (which has special GMP requirements), according to WHO GMPs, you can use the raw material up until its expiration date (I think you mean its retest date). The finished product stability is determined by your stability studies performed when you originally registered the finished product with the authorities. The finished product shelf life is not dependent on the specific batches of the raw material.


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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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