Adapting Roche’s Process Monitoring Program to the External Network
Posted on January 9, 2019
Kartoa Chow, Senior Engineer
Genentech, Inc., a member of the Roche Group
Introduction A holistic approach for biopharmaceutical product lifecycle management, as defined in guidance document Process Validation: General Principles and Practices published by the U.S. Food and Drug Administration (FDA), categorizes process validation into three stages: 1) Process Design, 2) ...
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