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 please is it comply to GMP to prepared batche in one holding tank and filled in to two different filling machines with different batch NO,s.
thanks
Answer A batch is defined as a homogenous mixture. As such your single tank formulation is ONE batch. When you fill it through different fill machines into the same size containers, this does not change the batch number. If however you use each fill machine to fill different size bottles, then you need to have different packaging batch numbers - the usual scheme being to have the bulk (as say) batch 12345; and then the two sizes of bottles as batch numbers 12345A and 12345B.
