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: "Dear Mr.Michael/ Ihope that you are in the best mode: I have two questions:
1)If time for stability analysis is due and I can not analyse the product at that time ,then I have to remove the product from the chamber,,where should I keep the samples (In fridge,freezer or in room temperature)can you give me a guidance for this point.
2)I have read the ICH stability evaluation (Q1E), but I'm confused about how to estimate the shelf life: is it by using formula of Y=2X or 1.5X ..etc system or by statistical analysis (pooling, ANOVA..etc).Realy i want to know what & when i should use these methods,Can you give an example. Thanks"
ANSWER: Moayyad:
You hope I am in the "best mode" - I am not sure what you mean my this, but I am fine - thanks.
Anyway.
You need to remove the samples on time per your stability protocol. If you cannot analyse them, then the best thing is to freeze the samples until you can. But .... FDA expects samples to be analyzed soon after being pulled. Within 3 days for 1, 3, and 6 month samples; within 7 days for 9, and 12 month samples; and within 14 days for samples beyond 12 months.
You absolutely need an SOP on this, and you need to follow the SOP.
FDA's general attitude is that 3 months accelerated data supports a 1-year shelf claim, 6 months supports 2-years shelf claim; but of course you need to substantiate these with room temperature study data.
I hope this helps.
What country are you based in?
Regards,
Michael Anisfeld
---------- FOLLOW-UP ----------
QUESTION: Dear Mr.Michael/Thanks for your valuable reply.I'm in saudi arabia.
For Q1: If the time is due and I keep the samples inside their chambers, and analyse them when I'm free (Analysis will be within 1 week)and I show this in the report as : results after 3months (+1 week),6 months (+ 5days for example.Is this acceptable instead of freezing samples?
For Q2)Is your reply for tentative shelf life? what about determination of perminant shelf life?
Thanks again,
Answer Q1. Seems like you are tying yourself in knots about this.
The key question you really need to ask if "why can you not do the analyses on time?" I suspect that the answer is that you are short of people (or trained people) in your lab - which now gets you into deeper GMP issues. There is a US FDA cGMP (21CFR211.22) requiring management to provide sufficient staff to perform all required activities. I suggest that you go speak to your boss, and demand more trained staff.
Q2. Sorry I should have clarified, accelerated stabilities provide tentative expiration dates; room temp studies provide permanent expiration dates.
