Lifecycle Approach to API Process Validation
1:00:28
YouTubeRegis Technologies, Inc.
Lifecycle Approach to API Process Validation
The goal of API process validation is to ensure the reliable production of high-quality active pharmaceutical ingredients from development through commercialization. The product lifecycle approach established in FDA's 2011 Process Validation Guidance requires different validation activities during the process design and process qualification ...
18.7K viewsNov 26, 2014
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