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
Expert: Michael Anisfeld Date: 3/12/2008 Subject: bulk stability
Question We would like to complete bulk stability on our drug product (and/or intermediates) in small fibre drums that may easily be placed in a chamber rather than the larger fiber drums that would require a lot of space over the hold time. Is this possible? If so, can a warehouse bulk storage study also be conducted the same way? And should we be looking at the force and pressure within the drum sizes or is the temp and humidity vs head space more important?
Thanks
Answer If you drug product is an "active pharmaceutical ingredient" (API), then you can keep your stability sample in a small version of fibre drums (easily purchased with a volume of about 100mL).
If you are performing a stability study then it requires controlled temperatures according to ICH guidelines. If you are keeping reserve (retention) samples, warehouse storage is acceptable.
