Corrective action and preventive action (CAPA, also called corrective action / preventive action) are improvements to an organization's processes taken to eliminate causes of non conformities or other undesirable situations. CAPA is a concept within good manufacturing practice(GMP). It focuses on the systematic investigation of the root causes of non-conformities in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).

Corrective Action is an action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent recurrences. Correction: Repair, rework or adjustment and relates to the disposition of an existing non-conformity.

Preventive Action is an action taken to eliminate the causes of potential nonconformity, defect or other undesirable situation in order to prevent the occurrence.

These are out come of the investigations or compliance for
  • Market Complaints
  • Deviations
  • Incidents
  • Out of Specification results
  • Audit observation of any internal or
  • external audit
  • Change controls
  • Market returns
  • product recall

Pharmaceutical companies should plan and execute a system for the monitoring of process performance and product quality to ensure a state of control is maintained. An effective monitoring system provides assurance of the continued capability of processes and controls to produce a product of desired quality and to identify areas for continual improvement. The process performance and product quality monitoring system should:

(a) Use quality risk management to establish the control strategy. This can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. The control strategy should facilitate timely feedback/feed-forward and appropriate corrective action and preventive action;

(b) Provide the tools for measurement and analysis of parameters and attributes identified in the control strategy (e.g., data management and statistical tools);

(c) Analyse parameters and attributes identified in the control strategy to verify continued operation within a state of control;

(d) Identify sources of variation affecting process performance and product quality for potential continual improvement activities to reduce or control variation;

(e) Feedback on product quality from both internal and external sources, e.g., complaints, product rejections, non-conformances, recalls, deviations, audits and regulatory inspections and findings;

(f) Provide knowledge to enhance process understanding, enrich the design space (where established), and enable innovative approaches to process validation.

Search