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,
I was wandering whether you could help with my query relating to stability testing of pharmaceuticals and pulling times. We currently have a number of samples on stability, our pulling times are 3 months, 6 months, 9 months and 12, but what we are unsure of is whether there is any leeway. So ie is it 3 months +/- 5 days for example? The other part of my question relates to testing time, once your sample is out do you then have a further number of days to test for example 10. So in my example would we have an additional 15 days as leeway? Do you know the answer and where this information can be found? Is the answer different depending on whether it's UK or USA? Our product is manufactured and sold in the UK.
Thanks
Amanda
Answer The answers you seek were covered in an FDA OGD Guideline, withdrawn a few years ago.
Samples with pull times of 1, 2 and 3 months need to be tested +/- 3 days
Samples with pull time of 6, 9 and 12 months need to be tested +/- 7 days
Samples with pull times of 18, 24, 36 moths need to be tested +/- 30 days
