AboutMichael Anisfeld Expertise 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
Experience
Past/Present Clients UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
Question QUESTION: One of my friends wants to reprocess the nearing expiry drug substance. If he does, then
What would be the expiry period of resultant batch?
Can we assign full expiry period?
Any regulatory reference?
ANSWER: If he reprocesses and recrystallizes the API, then he can claim the full original expiration date - as long as he has stability data to support this, based on the reprocessed material.
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QUESTION: For an API with expiration period of 3 years, after reprocessing of nearing expiry (after 2 years)of API,can he assign again 3 years to reprocessed material?
Answer you can do this on two conditions:
a. you have stability data (at a minimum 6 months accelerated data) to support the reprocessed materials "new" retest date, and
b. for the European and US (and perhaps other) markets - you have registered the reprocessing procedure with the authorities in your DMF.
