Regulatory Open Forum

In the United States, manufacturers must comply with biologic, drug, medical device, and HCT/P current Good Manufacturing Practice (cGMP) requirements, including as applicable for constituent parts of combination products. The ‘core cGMPs’ are the Quality System Regulation (QSR) for medical devices and current Good Manufacturing Practice for Finished Pharmaceuticals (drug cGMP) for drugs. cGMPs for biologic and HCT/P products also exist but are not a stand-alone. They instead rely upon the QSR and drug cGMP for core requirements, augmenting where appropriate.

For companies with combination products, it is challenging to meet the differing QSR and drug cGMP requirements with a single Corrective and Preventive Action (CAPA) system. Understanding the difference between Continuous Improvement (per the QSR) and Continual Improvement (per the drug cGMP) and the reasoning behind the difference, can help companies address CAPA requirements for both regulations using a single system.