Saturday, July 14, 2012

Changes Coming to FDA QSR for Prefilled Injection Devices

Manufacturers of prefilled drug delivery devices and their components need to begin preparing for compliance with the coming quality system regulation for combination products.

The following article is a very well written analysis of the situation, with very practical recommendations on how to get ready for the necessary changes.

Changes Coming to FDA Quality System Requirements for Prefilled Injection Devices > RAPS > Features - Article View:

"The rule is expected to require combination product manufacturers to comply with both Current Good Manufacturing Practice regulations for drugs and biologics (21 CFR 210, 211 (CGMP)) and the Quality System Regulation for medical devices (21 CFR 820 (QSR)), during and after formation of a combination product. This has significant implications for pharmaceutical and medical device manufacturers that produce medicated devices, prefilled drug delivery devices and their components."

'via Blog this'

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