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 (CAPA) procedures. One of the items that must be included in your procedure is to verify that the action(s) you have implemented is effective. The purpose of the effectiveness check is to determine if the actions you have taken have or have not eliminated the problem.
A company recently received the following observation:
…. Procedures for corrective and preventive action have not been adequately established.
a. CAPA Effectiveness checks are not documented or verified prior to signing off the effectiveness section in the CAPA form. For example:
i. CAPA … was opened for shipping devices to the wrong patient. There is no result of verifying effectiveness documented. This section was signed off and closed.
ii. CAPA … was opened for a repair device was returned to the wrong facility. There is no result of verifying effectiveness documented. This section was signed off and the CAPA was closed.
b. CAPA effectiveness was signed off prior to corrective and/or preventive action taken (solution implemented). For example: CAPA … was implemented and the effectiveness of verifying CAPA was done 2 days prior to implementation.
c. You could not provide the documentation of the implemented solution for review. As a corrective action to CAPA … new QA checks were to be instituted and training was provided. These documents were not provided for review.
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, CAPA within the Pharmaceutical Quality System.
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