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!

6 Replies
IPEC-Americas has issued a guideline on stability testing of excipients. You can find the guideline on the website:

The guide is a free download.
Hi Amanda,

WHO also has Annex 10, published in 2018:

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:

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
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
Hi Amanda,

I am new to this community and the world of Quality- so this suggestion could be quite useless, and you may have already used this resource. I am prepping for the CPGP certification, and the book of knowledge references ICHQ7A guidelines, which is now a part of Part II of the EU Guide to GMP. Annex 13 and Annex 16 of the EU Guide to GMP also has more information. 

I hope this helps!

HI Amanda,

I am in the clinical world but also use expiration and retest dates for small molecules based from the following:  
    1. EMA/CHMP/QWP/545525/2017, 20 September 2017
    2. GOV.UK Guidance Common issues: Pharmaceutical, Updated 12 July 2018