Additional Stability Guideline (other than ICH)
Hi Everyone,

I'm new to ASQ and the group! I thought I'd reach out to the group to see if anyone could recommend some good resources for me regarding stability/stress testing of APIs, finished drug products, and cosmetics. Currently, I've reviewed the ICH Q1 guidelines and am familiar with FDA GMP guidelines. I was looking for anyone who could provide recommendations for protocol design (i.e. best practices) and additional information on bracketing and matrixing.

Thanks in advance!

Cheers,
Amanda
4 Replies
IPEC-Americas has issued a guideline on stability testing of excipients. You can find the guideline on the website: www.ipecamericas.org

The guide is a free download.
Hi Amanda,

WHO also has Annex 10, published in 2018:
https://extranet.who.int/prequal/sites/default/files/documents/TRS1010_Annex10.pdf

Kim Huynh-Ba is the Chair of USP Chemical Medicines IV Expert Committee and has been active in the stability testing field for quite some time. She has a book on stability testing linked below. I have heard Kim speak, but have not read this book (I should). She has a lot to say about stability documentation and bracketing/matrixing and I assume that her book covers the subjects well:
https://www.amazon.com/Handbook-Stability-Testing-Pharmaceutical-Development-ebook/dp/B001VNCF2Q

In my experience in generics and from what I've heard at conferences, there are many different ways to set up matrixing/bracketing studies. It seems that it is a good idea to start off with a more conservative stability study protocol and adjust it as the product matures and you gather more supporting data. You always need a scientifically sound justification for matrixing/bracketing of stability studies. For pre-approval studies, it is a good idea to consult with FDA to see if your matrixing/bracketing plan and justification is acceptable and of course any change to your stability commitment post-approval must be agreed to by the agency.

Hope this helps.
-Carl McBurney
Hi 
Amanda 
Iam familiar with what you have discussed there also COTS which essential for the food safety practices that I would like to add
thank and regards 
girishwaran sundar