The newly revised and expanded draft guidance titled Q1 Stability Testing of Drug Substances and Drug Products (here) was published today. This draft guidance represents “a consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May 1997, January 2003, June 2004, and July 1996, respectively.” In addition, it “provides stability related guidance for product categories such as advanced therapy medicinal products, vaccines, and other complex biological products including combination products that were not previously covered under the existing stability guidances” (see the FR notice here).
It is 108 pages of unadulterated stability joy, outlining just about everything you would want to know about stability programs, assessment, matrixing, and on and on, and I’m certain you’ll keep it at your bedside for those nights you just can’t fall asleep. While the guidance is very comprehensive, of course, there are always those little stability questions you may have that the Agency has not considered in the guidance. For instance, I previously had a question about stability requirements for the addition of a new strength of a product after the original FDA approval. I know the answer is somewhere but it always takes me about a week to find the guidance document that addresses that specific issue. It doesn’t come up often but I do question my memory sometimes, especially with all of the guidance changes that occur over time.
Anyway, enjoy the document and remember that it is in draft so if you think that one of those nagging stability questions that you may have isn’t addressed in the document but should be, you can always submit a comment to the draft!
