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
I was wanting to ask this since a long time....the USFDA GMP certificate does not bear a validity period...but the normal industry norms in India is 2 years...i.e. USFDA does re-audit for GMP after 2 years under normal operations and Export of the company products....but the website does not claim it to be 2 years...can you shed some light onto this aspect please?
Thanks in advance...
Answer FDA Certificates of GMP do not bear expiration dates because FDA has the attitude that the facility was only in GMP compliance on the specific date of the inspection, and only specifically for the areas inspected. Hence it cannot provide a future expiration date.
