Corrective and Preventative Action – or CAPA. Sometimes the mere mention of this can send pharmaceutical companies and their staff into panic mode, especially if it comes on the heels of a 483 warning letter.


With everyone scrambling to evaluate how quality issues – whether in the lab or as part of the manufacturing process – can be addressed, they tend to hit the panic button. Rushed decisions ensue, and then teams are scrambling to find alternate methods of meeting FDA requirements in a shortened timeframe.


But it doesn’t have to be this way. And in fact, it shouldn’t. If we drill down to the basics, a CAPA is a tool that companies use to check and implement corrective actions throughout a site or at multiple sites. So with “tool” being the operative word, essentially, one piece – or step – of the larger picture to achieving compliance, then it should make sense that a step-wise or phased approach would be ideal in helping to successfully progress through an investigation, save significant costs, and achieve and maintain compliance.


So what does a phase-based CAPA consist of?

  • Step 1: Identification – Identify which equipment or process initiated the need for a CAPA, where it happened and why.


  •  Step 2: Evaluation – Figure out what the issue did – or didn’t – affect, as well as determine how or if this issue impacts compliance with regulation standards.


  • Step 3: Investigation – Get to the meat of it: Why did the issue happen? And how? What is the solution and corrective action to each contributing factor?


  • Step 4: Resolution – Fix existing problems; institute preventative measures to deter a re-occurrence and engineer a solution that would prevent other problems from occurring.


  • Step 5: Measurement – Before a CAPA is closed, there should be some form of measurement to ensure that the corrective action is indeed working as it should within a predetermined amount of time.


Having a plan is critical for an effective phase-based CAPA. It should include buy-in from all employees – from senior level staff to line personnel. Although it is sometimes hard to imagine at the outset how this process contributes to the overall picture, it’s important that everyone understands that each step is a critical piece of the pharmaceutical ecosystem – just as their individual roles are. What results is a complete system that works together to efficiently and cost-effectively resolve unanticipated events.


Want more information? Contact Mike McNees at (443) 822-2479 or email [email protected]


Interview with Syndicus GLP lead


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