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 Hello!
I have a problem, I need to write a registration documentation in EU format (not CTD) - the IIF chapter for stability.
There are two parts; IIF1: stability of active substance and the IIF2: stability of finished product.
With second I don't have problems, but I have for the first. When I have the DMF for API I just need to write „See Drug master file". But for this particular substance I have only CEP (certificate of suitability to European Pharmacopoeia). Can I write “see CEP”? In CEP there is no information regarding stability, and if some manufacturer obtains the CEP, they are not prone to sending the DMF also.
Thank you in advance.
Answer I commiserate with you, having been in the same situation a few years back.
The EU reviewers demand the actual API stability data (and to be honest you really need to review it yourself). Either the API manufacturer provides it to you, or they need to file a Drug Master File (DMF) with the details directly to EMEA.
If you do not have the stability details then it sounds like your Qualified Person has also not audited the API facility. We have on staff a European registered QP, and we perform about 25 API audits annually to EU GMPs. We are in India and China about once every ten weeks, and if you need an API audit we'd be happy to perform one for you (contact me off-line at maniseld@globepharm.org for details).
