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.
- 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
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.
- 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
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.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