Publication

Article

Pharmaceutical Technology

Pharmaceutical Technology-12-15-2019
Volume2019 eBook
Issue 3
Pages: 12–13

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

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).

 

 

Articles in this issue
PTebook1219_PharmacopeiaCompendia_PT6_RevisionProcess.jpg
Revision Process for Global/National Pharmacopoeias (eBook)
PTebook1219_Resources_Organizations.jpg
Regulatory and Standard Setting Organizations
PTebook1219_Resources_Guidelines.jpg
Resources, Guidelines, and Guidance Documents
PTebook1219_Quality_DOE_Shanley.jpg
Design of Experiments Gains Ground in Biopharma Development
PTebook1219_RegulatoryUpdate_Peters.jpg
Warning Letters Signal Steps to Compliance
PTebook1219_QRM_Plans_ATE_Schniepp.jpg
Quality Risk Management Plans Create Effective Quality Systems
PTebook1219_Compliance_Quality_Shanley.jpg
Moving from Compliance to Quality
PTebook1219_PharmacopeiaCompendia_PT7_SurveillanceProcess.jpg
Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions (eBook)

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