A company recently received the following observation regarding CAPA:
…. Procedures for corrective and preventive action have not been adequately established.
Specifically, per your procedure SOP … “Corrective and Preventive Actions”, it states that a corrective action requests should be verified for effectiveness and is recorded on a CAR Form. However, your firm did not verify or validate the corrective actions for the four CAPAs to ensure that such an action is effective and does not adversely affect the finished device.
a. CAPA … was generated due to an observation from the previous FDA inspection to correct document controls for design changes; the effectiveness check was left blank.
b. CAPA … was generated due to an observation from the previous FDA inspection to correct the sampling plan implementation; the effectiveness check was documented as “N/A”.
c. CAPA … was generated due to an observation from the previous FDA inspection to correct the lack of monitoring of in process inspection for … parts; the effectiveness check was left blank.
d. CAPA … was generated due to an observation from the previous FDA inspection to implement supplier qualifications; the effectiveness check was documented as “N/A”.
Your firm’s president indicated that these CAPAs were completed and closed; All four CAPAs were approved, signed, and dated without completing validation or verification to ensure the corrective action was effective.
The Code of Federal Regulations (21 CFR 820.100 Corrective and Preventative Action) states that each manufacturer must develop, maintain, and implement a written Corrective and Preventative action procedure. 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.
According to GMP Trends® Annual Reports, observations pertaining to CAPA (21 CFR 820.100) has been in the top 5 observations cited by the FDA each year for the last 5 years.
For more information on implementing CAPA programs, refer to the following: FDA guidance document Corrective and Preventative Actions (CAPA) and FDA presentations CAPA Basics, CAPA within the Pharmaceutical Quality System.
To view more observations pertaining to equipment cleaning, refer to the following GMP Trends® Issues: 1103, 1102, 1101, and 1100.
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