According to the Code of Federal Regulations (21 CFR 820.100 Corrective and Preventative Action), each manufacturer must develop, maintain, and implement written Corrective and Preventative action, or CAPA procedure. Procedures should include the following:
- Analyzing processes, operations, and quality data to identify existing and potential causes of nonconforming product or other quality problems
- Investigate the cause
- Identify the actions needed to correct or prevent recurrence
- Verify the action is effective
- Update documentation to implement changes
- Ensure changes have been related to appropriate personnel
All CAPA activities and their results must be documented and submitted for management review.
A company recently received the following observation:
…. Procedures for corrective and preventive action have not been adequately established.
Specifically, SOP…, “Corrective and Preventive Action Procedure”, has not been adequately established as CAPA records do not include all required information such as documentation of implementation of corrective and preventive actions, investigation, objective evidence of corrective/preventive actions and/or verification of effectiveness. Additionally, corrective and preventive actions are not taken commensurate with risk.
For example: CAPA … was issued for damaged products related to …. Documentation of investigation/issue and scope of the problem is inadequate and there was no follow up on the Corrective and Preventive Action Form (CAPA). Your firm continues to see reports (at least 13 to date) of these or similar … failures, yet there is no documentation of containment and/or corrective actions to this issue to date. Moreover, there is no documentation of required Executive Management authorization/sign off on this record.
According to GMP Trends® Annual Reports, over the last 5 years the observations pertaining to CAPA (21 CFR 820.100) has been in the top 5 observations cited by the FDA each year.
For more information on implementing CAPA programs, refer to the following FDA guidance documents, Corrective and Preventative Actions (CAPA) and FDA presentations CAPA Basics, and CAPA within the Pharmaceutical Quality System.
To view more observations pertaining to equipment cleaning, refer to the following GMP Trends® Issues: 1076, 1075, 1073, and 1069.
Stay in Compliance! Subscribe today!
Recent Comments