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Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of BioPharm International's Editorial Advisory Board.
Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products
The purpose of a quality risk management plan is to help ensure continued compliance with regulatory requirements, such as good manufacturing practices or good laboratory practices, when events occur during manufacturing that potentially impact patient safety and product quality. Learn the four basic elements that should be included in a quality risk management plan.
eBook: Regulatory Sourcebook, December 2019
When referring to this article, please cite it as S. Schneipp, “Quality Risk Management Plans Create Effective Quality Systems," BioPharm International Regulatory Sourcebook eBook (December 2019).