Conduct↦Quality and Risk↦Regulatory Inspections↦Corrective and Preventive Actions
What is it? Why is it important?
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.
What do I need to do?
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 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.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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