Your Easy Guide to Clinical Studies

Corrective and Preventive Actions (CAPA) are adaptations and improvements taken to eliminate causes of non-compliance.

 

CAPAs include a set of actions that require:

• A root-cause analysis of the situation or event, in order to explain why non-compliance did occur
• The implementation of corrective actions that allows for a non-compliant activity to return to compliance
• The implementation of preventive actions with the aim to avoid the reoccurrence of the non-compliant event

 

When handling CAPAs a risk-based approach should be used. A risk-based approach assesses the potential impact of non-compliances, and helps to define the scope and required resources needed for CAPA implementation.

 

After an audit or inspection, the SP-INV writes a CAPA plan that lists a response on how to handle non-compliance (findings) noted during an audit or inspection.

As a SP-INV, ensure to establishing a risk-based Quality Management System during study planning and development, this allows:

• Critical to Quality factors to be identified prior to study conduct
• The implementation of quality processes and risk control-measures, with the aim to prevent the occurrence of non-compliance

 

CAPA management after an audit or inspection (e.g. Swissmedic)

• Perform a root-cause analysis of non-compliances/findings from the audit/inspection report
• Assess the implementation of corrective actions, and whether they can be implemented. Implement, without delay, corrective actions regarding high-risk non-compliances (e.g. participant safety, data quality)
• Assess the implementation of preventive actions, and decide on required quality processes and /or risk control-measures
• Document corrective and preventive actions in a CAPA plan, include timelines until CAPA resolution
• Submit the CAPA plan for approval to the audit/inspection responsible entities
• Once approved, implement the CAPA plan within defined timelines
• In the event of a re-audit/re-inspection, the implementation of the previously approved CAPA plan is re-evaluated

References

ICH GCP E6(R3) – see in particular guidelines

• Glossary: Inspection, Audit
• 3.10 Quality management
• 3.10.1 Risk Management
• 3.11.2 Audit

ICH E8(R1) – see in particular

• 3.2 Critical to Quality Factors

ISO 9001 (access liable to costs) – see in particular section 

• QMS Requirements

ISO 19011 (access liable to costs) – see in particular section

• Guidelines for auditing management systems

EMA – see in particular

• Guidance for the preparation of good clinical practice inspection reports and communication of inspection findings

 

Documents

• Risk Assessment Form for Clinical Research Projects