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 Dear Sir
Is there any legal regulation require studying the first three production batches of a product under stability study? Or does it required (stability study) for the process validation batches?
The case is:
Four batches from the same product prepared, and the production process validated for the last three batches since the first one require rework.
What batches should we study under stability program?
Please provide me with reference if possible?
Thanks and kind regards
Answer There is a legal requirement in the US and EU that 3 stability batches be prepared, and that 3 validation batches be prepared. Most people try to combine them such that the stability batches and the validation batches are the same.
For stability do not use the reworked batch, unless you want to also make an application demonstrating that a reworked batch is also stable.
