Quality Risk Management Plans Create Effective Quality Systems

December 15, 2019

Susan J. Schniepp

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Pharmaceutical Technology, Pharmaceutical Technology-12-15-2019, Volume 2019 eBook, Issue 3

Page Number: 12–13

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.

Read this article in Pharmaceutical Technology’s December 2019 Regulatory Sourcebook.

Article Details

Pharmaceutical Technology
eBook: Regulatory Sourcebook, December 2019
December 2019
Pages: 12–13

Citation

When referring to this article, please cite it as S. Schneipp, “Quality Risk Management Plans Create Effective Quality Systems," Pharmaceutical Technology Regulatory Sourcebook eBook (December 2019).