Use of confirmed OOS material in other projects
Started by Quest for QA, Mar 15 2024 04:47 PM
I know what I'm about to ask is frowned upon by FDA, but I'm looking for a specific reference, either a Warning Letter, reg, etc....
When a drug product has a confirmed OOS for one trial or market, it it OK to use for another trial or market? For example, the drug product is exactly the same process, but the company wants to use it in another trial or market (e.g. Japan) when it failed US specifications.
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This may be a difficult question for this forum to give input on, as the regulations for Food vs Drugs are different, even though both are under FDA jurisdiction. When it comes to the US FDA, IFSQN is mostly concerned with Subchapter B of Title 21, while Drugs fall under Subchapter C.
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