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 I would like to know is it ok to transfer a stability study from one country to another during the stability study, we have a situation where we have three months stability at the three stability conditions (ICH
guidelines) but now we are thinking of transferring this study to a contract company, this would involve shipping it by air. Is it ok to do this and what checks would we need to perform for the regulatory authority's.
Answer In principle I do not see any problem with this except one.
The transportation issues are not of real concern (best if you ship in a refrigerated state), and I am assuming that the stability chambers that the product will, in future, sit in are properly qualified.
The big issue will be effective, proven and documented, validation of the assay transfer. If this is done right, then there should be no problems.
