What is it? Why is it important?

Corrective and preventive actions (CAPA) are improvements taken to eliminate causes of non-conformities or other undesirable situations. It includes a set of actions that are required based on given laws and guidelines.

CAPAs require:

  • A root-cause analysis of the situation or the event
  • Implementation of corrective actions that allows an activity to return to compliance
  • Implementation of preventive actions that can anticipate an event and thus attempt to avoid its occurrence

More

After an audit or inspection, the SP-INV writes a CAPA plan that lists a response as to how findings will be handled.

What do I need to do?

  • Analyse findings listed in the audit / inspection report
  • Define CAPAs for each listed finding
  • Write a CAPA report to be forwarded to the audit or inspection team for approval. Include a timeline upon which CAPAs will be implemented
  • Upon approval implement the CAPA plan
  • Inform the audit or inspection team of any delays in CAPA implementation
  • If applicable update the RAT

For more information refer to Ethics and Laws in this Study Guide.

More

  • The audit or inspection is concluded once the CAPA plan has been approved by the audit or inspection team
  • Upon a re-audit or inspection, the implementation of the CAPA plan can be re-evaluated
  • Upon completion of an audit the site will receive an audit certificate to be filed in the ISF

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.29 Inspection
  • 1.6 Audit
  • 5.0 Quality management

ISO 9001 – see in particular section

  • QMS Requirements (access liable to costs)
  • ISO 19011 – see in particular section
  • Guidelines for auditing management systems (access liable to costs)

EMA – Classification and analysis of GCP inspection findings

Documents

Abbreviations
  • CAPA – Corrective and Preventive Actions
  • CTU – Clinical Trials Unit
  • ISF – Investigator Site File
  • RAT - Risk Assessment Tool
  • SP-INV – Sponsor-Investigator
Conduct ↦ Quality and Risk ↦ Regulatory Inspections ↦ Corrective and Preventive Actions
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Quality and Risk ↦ Regulatory Inspections ↦ Corrective and Preventive Actions

Please note: the Easy-GCS tool is currently under construction.