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 Question regarding how to document when we encounter an excursion in the temperature or humidity in out stability chamber. we are new to the gmp field and I do not know if it would be best to document it in a deviation, a non conforming or oos.
any suggestions or formats?
Answer Steve:
a. when you have a temp/humidity excursion you do not have a deviation, you have an out-of-specification situation. Deviations are when you cannot follow an SOP, and have to deviate in methodology.
b. yes, you need to document and investigate the OOS.
I provide commercial consulting on all matters GMP, and would be delighted to assist you. Please contact me at manisfeld@globepharm.org to further discuss how we might be able to assist you.
Best Regards,
Michael Anisfeld
Globepharm Consulting
www.globepharm.org
