---
title: Effective Corrective and Preventive Action (CAPA) in a GMP Environment
description: Effective failure investigation, root cause analysis and corrective and preventive action (CAPA) for pharmaceutical companies in a GMP environment.
---

[SeerPharma Blog ](https://blog.seerpharma.com)

# [Effective Corrective and Preventive Action (CAPA) in a GMP Environment](https://blog.seerpharma.com/effective-corrective-and-preventive-action-capa-in-a-gmp-environment)

 Written by [SeerPharma](https://blog.seerpharma.com/author/seerpharma) | Jun 23, 2016 12:00:20 AM

 **As a Pharmaceutical company, you are required to investigate the cause of quality failures or production problems. Surprisingly though, “Failure to thoroughly investigate…” is a common finding from [regulatory inspections](https://blog.seerpharma.com/fda-and-tga-gmp-inspection-help-for-pharmaceutical-company) in the PIC/S, TGA and FDA GMP environment.**

****

To conduct effective failure investigations and perform root cause analysis you must ensure that you have a structured investigation process driven by your corrective and preventive action (CAPA) system.

“*CAPA* is a well-known cGMP regulatory concept that focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence.”  
*FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations, 2006*

Despite CAPA references in the PIC/S  Guide to GMP and FDA 21 CFR Part 211 and a dedicated section in the ICH Q10 (Pharmaceutical Quality System) guideline,  CAPA continues to plague pharmaceutical companies.

To extract the most out of your CAPA system, you must:

- Understand the language of investigation, problem solving and CAPA
- Identify regulatory requirements and expectations related to failure investigation, root cause analysis (RCA) and CAPA
- Know when to use risk assessment
- Outline the steps in a common failure investigation and root cause analysis process
- Understand when and where to apply problem solving methods and tools
- Document failure investigation and root cause analysis process activities
- List the essential features of effective CAPA systems
- Ensure your CAPA process is efficient and effective

[Contact us](https://www.seerpharma.com/contact-us) for advice on how to get more value from your CAPA system and address concerns with quality or production of your pharmaceuticals.  We can help you eliminate causes of non-conformities and prevent their occurrence or recurrence.  You may also be interested in our [CAPA training](http://seerpharma.com/services/training/enterprise/sp6505-a-practical-approach-to-failure-investigation-root-cause-analysis-and-capa/) course.

[View full post](https://blog.seerpharma.com/effective-corrective-and-preventive-action-capa-in-a-gmp-environment)

```json
{
  "@context" : "http://schema.org",
  "@type" : "BlogPosting",
  "author" : {
    "@type" : "Person",
    "name" : "SeerPharma"
  },
  "dateModified" : "2018-06-19T01:30:17.972Z",
  "datePublished" : "2016-06-23T00:00:20Z",
  "headline" : "Effective Corrective and Preventive Action (CAPA) in a GMP Environment",
  "image" : {
    "@type" : "ImageObject",
    "height" : 299,
    "url" : "http://cdn2.hubspot.net/hubfs/2056580/Images/Blog/Tablets-Pharmaceutical.jpg",
    "width" : 448
  },
  "mainEntityOfPage" : "https://blog.seerpharma.com/effective-corrective-and-preventive-action-capa-in-a-gmp-environment",
  "publisher" : {
    "@type" : "Organization",
    "logo" : {
      "@type" : "ImageObject",
      "height" : 60,
      "url" : "/hs/hsstatic/content_shared_assets/static-1.4092/img/default-amp-logo.png",
      "width" : 60
    },
    "name" : "Blog"
  }
}
```