Following a presentation at the recent PSDG 2021 Meeting/KENX Laboratory University event, a question was raised regarding how to compile the best OTC Product Stability Report for Regulatory Submission.
Below is my response, but I’ll bet some of you have some additional input on references, experiences, etc. to add. Please do.
Regarding OTC reports, I didn’t find the Holy Grail, but I did find some insights into what the industry, (specifically through CHPA) has been thinking . In addition, the Consumer Product Testing Corporation has put together an nifty introductory article, but the crux of what should be in an OTC Report is really an agglomeration of ANDA requirements, OTC Guidance (here and here), and best practices from folks compiling data for CMC segments. A good start is working with the product’s Development Report to support your protocol and justify the conditions and Stability-indicating tests used.
You might also check out some of the references listed within the documents associated with the above links. I’ve added several Guidances to the StabilityHub Regulatory listings from these.
This topic was modified 2 months ago by John O'Neill. Reason: Adding links