FDA Center for Devices and Radiological Health (CDRH) GMP expert Kimberly Trautman is spearheading an effort to clean up and harmonize the definitions around corrective and preventive action (CAPA) across the agency in line with a Global Harmonization Task Force (GHTF) guideline on CAPA that is nearing release.
The implications are significant for the GMP/quality system inspection process and compliance expectations for drugs, devices and their combinations.
Non-conformity investigations and the follow-up corrective action are a central focus in FDA drug inspections and the 483s and warning letters they engender (IPQ May/June 2009 Report), and preventive action is central to the new continuous improvement/quality system paradigm.
Trautman highlighted the significance of the CAPA definitions and the effort to clarify them at the annual PDA/FDA conference in Washington, D.C. in mid-September.
The CDRH official has played a key role in refining the device quality system expectations and standards at FDA and globally, which, in turn, has helped drive the evolution of quality system concepts for pharmaceutical and combination products. She led the revision process on the device GMPs that took place in the 1990s, and is currently a member of the U.S. team on Technical Committee (TC) 176, which authors the ISO-9000 series of standards. She is also on TC 210 working on ISO-13485, the device quality management system standard.
Trautman prefaced her remarks by explaining that the slides she was presenting were the same ones she has been using in conducting training sessions over the summer for district device investigators, and that the definitions involved are those developed through the global standards-setting process.
“When I talk about these definitions,” she stressed, “I am using ISO-9000, which is the vocabulary standard for all quality management system standards – environmental, aerospace, automotive, everybody,” including human products.
Rather than devices, biologics and drugs, “the standard world views us as human products,” she pointed out. “So we need to really start thinking in that manner and try to start pulling our mindsets together – especially in light of the increase in nanotechnology and combination products.”
[Trautman’s analysis of how the CAPA definitions are gelling internationally and the regulatory implications for drugs and devices continues for subscribers here. The related dialogue at the PDA/FDA conference is also reviewed. To subscribe to IPQ click here.]