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Validation failure is not an option. Should it be? Under the current regulations, there is no system that allows a firm to openly deal with validation failures.(Final Word)

Publication: Biopharm International
Publication Date: 01-JUN-08
Format: Online
Delivery: Immediate Online Access

Article Excerpt
The International Conference on Harmonization (ICH) Q8-10 guidelines and the US Food and Drug Administration's out-of-specification (OOS) guidance document provide approaches that allow for regulatory flexibility in process development and manufacturing with the intention of bringing certain...

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...quality standards of the biotech industry closer to those of more established industries such as the automobile sector. These quality guidelines have bridged many of the gaps between established regulations and the need for flexibility in quality...

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