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 Hi Michael,
We are using very large pails (0.75 cubic meters volume)to hold our solid dosage products before packaging. In majority of the cases, packaging does occur within 30 days of the manufacturing. However, there are instances where bulk stays in these pails for 3-4 months. Since these are very large pails, we can't store them at 25/60 conditions to study bulk stability. Is there any other way to establish bulk hold time of 3-6 months, for all of our products? Please advise. Thanks
Answer The critical questions are:
a. how are the bulk pails sealed, and
b. what are the storage temps/humidities.
Try to mimic the pails materials of construction and the seal on a small scale and hold tablets in these "smaller" containers for 6 months to perform a room temperature stability, or at 40oC/75%Rh to simulate an accelerated stability.
