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Post: Stability Testing
10-31-05 05:14 AM - Post#3036
We are manufacturers of OTC (finished) drugs. I want to know if someone knows of any regulations regarding 1. effect of a change in manufacturer of an API used to make finished good on stability study 2. effect of a change in mfgr of an excipient used to make finished good on stability study.
I know or came acroos regulations on post-approval changes for API and other excipients (which states change in suppliers), but do these regs apply for OTC.