The FDA’s Office of Good Clinical Practices (OGCP) is an important resource for clinical trial professionals who can’t find the answers they need in the agency’s multitude of regulations, guidances and policies.
OGCP fields questions submitted via email to email@example.com, interpreting the FDA’s position, offering advice on how to proceed and pointing out key documents and resources that provide more in-depth guidance.
The following examples of questions and OGCP answers are excerpted from the book GCP Questions: FDA Answers.
Question: Can you define FDA’s expectations for preventive actions? Currently our Quality System within our company defines preventive actions as per GMP definitions in that Preventive Actions are to prevent a quality issue or event from occurring.
In the GCP space we implement Preventive Actions in response to quality issues or events that have already occurred, have a corrective action implemented if possible and implement a preventive action to prevent it from reoccurring.
What is FDA’s definition of a Preventive Action in the GCP space?
Answer: Thank you for your inquiry. Corrective and preventive action (CAPA) programs are not specifically addressed in FDA’s regulations related to clinical trials (21 CFR parts 50, 56, 312 and 812) but are discussed in the quality system regulation for medical devices (21 CFR part 820).
For GCPs FDA would expect an investigator, the investigational site and/or the sponsor to take corrective actions when issues arise during a clinical investigation and to document the actions taken. Several FDA guidance documents indicate this. See for example:
These guidance documents indicate that FDA review of records may include CAPA plans specific to a problem that occurred during a trial and CAPA plans that are part of trial monitoring or quality assurance. Compliance Program Guidance Manuals (CPGMs) were developed to provide uniform guidance and specific instructions to the FDA field investigators for conducting inspections of Clinical Investigators (CP 7348.811), Sponsors (CP 7348.810), In-Vivo Bioequivalence facilities (CP 7348.001), Institutional Review Boards (CP 7348.809), and Nonclinical Laboratories (CP 7348.808). FDA makes these documents available to the public at http://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/ucm255614.htm. Specifically, the CPGM for Sponsors and Clinical Investigators each discuss corrective actions and what investigators will look for with regard to corrective actions during an inspection.
Also, the definitions that have been referenced for Corrective Action and Preventive Action in presentations made by FDA staff (which can be found at http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm337109.pdf) are from ISO 9000:2005.