Your Easy Guide to Clinical Studies

Corrective and Preventive Actions (CAPA) are adaptations and improvements taken to eliminate causes of non-compliance. CAPAs includes a set of actions that require:

• A root-cause analysis of the situation or the event
• 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

 

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 the audit or inspection.

As a SP-INV:

• 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 stating until when CAPAs will be implemented
• Upon approval by the audit/inspection team, implement the CAPA plan within defined timelines
• As applicable, update the RAF
• In the event of a re-audit or re-inspection, the implementation of a previously approved CAPA plan can be re-evaluated

 

SP-INV Audits

SP-INV can audit participating study sites. Procedures are as described for regulatory inspections. Based on findings, the Site-INV writes a CAPA report including timelines. The SP-INV approve the CAPAs and supervises its implementation. Upon completion the Site-INV receives an audit certificate to be filed in the ISF.

 

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

• Risk Assessment Form for Clinical Research Projects