Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
|Articles|December 15, 2019
- Pharmaceutical Technology-12-15-2019
- Volume 2019 eBook
- Issue 3
Quality Risk Management Plans Create Effective Quality Systems
Author(s)Susan J. Schniepp
Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products
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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.
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).
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