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.
Guidance material for starting SQF implementation
Bulk raw material receiving and traceability
Checking frozen incoming material using digital probe thermometer
Foreign Material Handling for product with meat filling
Hazard of Using Aluminum Foil as Packaging Material
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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.
Guidance material for starting SQF implementation
Bulk raw material receiving and traceability
Checking frozen incoming material using digital probe thermometer
Foreign Material Handling for product with meat filling
Hazard of Using Aluminum Foil as Packaging Material
Mixed Pallet - Raw Material
Control of Foreign Material from Carton Box
Hazard Analysis and identification of raw material and ingredients
Is it ok to use Used Raw Material Packaging as Secondary Packaging for Other Raw Material
Foreign Material SS Metal