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 BioPharm International’s December 2019 Regulatory Sourcebook.
BioPharm International
eBook: Regulatory Sourcebook, December 2019
December 2019
Pages: 12–13
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).
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.