Corrective and Preventive Action

Corrective and Preventive Action or Corrective and Preventive Action (CAPA) is a concept within Good Manufacturing Practice (GMP). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their reoccurrence. To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions undertaken. CAPA is part of the overall Quality management system (QMS).

Concepts

• Remedial corrections of a problem which is identified.
• Root cause analysis combined with corrective action to help understand the cause of the deviation and potentially prevent recurrence of a similar problem.

A common misconception is that preventive action is to avert the occurrence of a similar potential problem. This process is all part of corrective action, because it is a process of determining such similarities that should take place in the event of a discrepancy.

Preventive action is any proactive methodology used to determine potential discrepancies before they occur and to ensure that they do not happen (thereby including, for example, preventive maintenance, management review or other common forms of risk aversion). Corrective and Preventive Actions both include investigation, action, review, and further action if so required. It can be seen that both fit into the Plan Do Check Act philosophy as determined by the Deming - Shewhart cycle.

See also

• Good Automated Manufacturing Practice (GAMP)
• Statistical process control
• Process capability
• Six Sigma
• Common cause and special cause
• Common Cause Variation
• Special Cause Variation
• Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
• Validation (drug manufacture)
• EudraLex

External links

• Q7 : Good Manufacturing Practices for Pharmaceutical Ingredients (ICH)
• Quality Systems Approach to Pharmaceutical CGMP Regulations (FDA)
• Good Automated Manufacturing Practice (GAMP)
• Good Manufacturing Practices (GMPs) and Quality Assurance