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 Is it accepted to retest the raw materials (API's/ inactives) when it's reach the "expiration date" , or it is just allowed for raw materials with "retesting date" ?? also what is the deference between "retesting date" and "expiration date"?
Please provide me with the official reference if possible.
Best regards
Answer Under ICH-Q7 (GMPs for APIs) all APIs and by extension excipients) should have "retest dates". When the retest date is reached, the user has one of two options:
a. retest the material, and if it passes, use it wthin 30 days; or
b. start a long term stability study to extend the expiration date for say 1 year, or 2 years.
Much better is to order the API in smaller qantities and never get to the retest date.
