1 Posts
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
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
6 Replies
3 Posts
2 Posts
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.
The guide is a free download.
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7 Posts
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
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
3 Posts
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
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
1 Posts
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!
Best,
Shai
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!
Best,
Shai
8 Posts
HI Amanda,
I am in the clinical world but also use expiration and retest dates for small molecules based from the following:
I am in the clinical world but also use expiration and retest dates for small molecules based from the following:
-
- EMA/CHMP/QWP/545525/2017, 20 September 2017
- GOV.UK Guidance Common issues: Pharmaceutical, Updated 12 July 2018
