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 A bulk of tablets was made 2 months ago. It has been waiting since then to be put in the primary package. Do we need to test again, if yes what parameters?
Answer FDA allows up to 30 days storage without the need for supporting stability data on the bulk. as such you cannot release the batch without supporting stability data.
Start your packaging, and quarantine the material. Simultaneously start an accelerated 3 month stability study. If after the 3 months study the data mimics original ANDA data, release the batch - if it does not, then do not release the material.
