Are you properly initiating your CAPA Procedure BEFORE taking Corrective Action? 

A robust corrective and preventive action (CAPA) system is critical for maintaining compliance and product quality. The CAPA procedure outlines the steps an organization must take when an issue arises that requires corrective and preventive measures.

At some point within the course of an investigation, it may become obvious that a Corrective Action is needed.  

A pitfall that firms should avoid is initiating Corrective Action before opening up a formal CAPA Procedure. 

The following Form-483 Observation illuminates this exact circumstance:

“ …. Procedures for corrective and preventive action have not been adequately established. 

Specifically, your procedure SOP…,, “CAPA Management” does not ensure that the CAPA process is adequately controlled. For example:

a. Your procedure does not ensure that CAPAs are initiated to document the investigation and corrective actions. 

During my review of your firm’s complaints, I found numerous complaints had been opened for … dropping suddenly. Your firm started investigating the issue early this year and started initiating a possible corrective action without opening a CAPA. CAPA … was initiated during the establishment inspection 12 months after the start of the investigation.”

Properly establishing the CAPA procedure before Corrective Action is critical for a robust quality system. 

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 actions, or CAPA procedure.  

When establishing your CAPA Procedure consider:

  • Sources That Trigger an Investigation
  • Timing of Investigation Initiation 
  • Scoping the Investigation
  • Ensuring Adequate Resources
  • Documentation Requirements

Always remember, if you find yourself taking Corrective Action, there needs to be a CAPA in place. 

Over the last 5 years, the observations pertaining to CAPA (21 CFR 820.100) have been in the top 5 observations cited by the FDA each year as noted in GMP Trends® Annual Reports.

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 CAPA, refer to the following GMP Trends® Issues:  1131, 1128, 1127, 1120.

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