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 there
I saw your answer regarding the frequency of testing for stability and wonder if microbiological testing for the same samples has the same frequency?
What documents is it based on?
Kind regards
Agnieszka
Answer If the study is to establish an expiration date for a new product, then microbial testing is typically performed at time zero and annually.
If the study is for on-going product evaluation, then stability testing is usually at time zero and at the product expiration date.
