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 want to ask about retained samples.When the drug product packed it may have many consignees.Is it necessary to sample from each consignee a reserve sample?(If yes): what is the quantity for all consignees?
Answer It frequently happens that a single batch of product is packed in the same primary packaging, but the secondary packaging (tech labels, cartons, etc.) are different for different markets. Where this is tech case, then you only need to keep one example for the retained sample - you do not need to keep a sample of each different labeling.
BUT ... the above only applies where you have the same primary packaging configuration for all different markets to which the batch is destined.
The batch records for each different secondary packaging will, of couse, have copies of the specific labeling used on each different packaged batc.
