Corrective and Preventive Actions, Completion of an Audit, Audit Certificate

8 Corrective and Preventive Actions

Implementation of a CAPA plan after the conduct of an audit is necessary to eliminate present and potential causes of non-conformity and prevent re-occurrence or future occurrence. Once the conduct of the audit is complete the auditor should be provided a CAPA plan to the auditee that will be utilized to remediate issues of non-compliance and potential non-compliance identified during the audit process. The CAPA plan should, at minimum, require the auditee to identify the root-cause of audit findings and describe whether corrective and/or preventive actions will be necessary to address the audit findings.

9 Completion of an Audit

Upon receipt of the preliminary responses to the CAPA from the auditee, the audit is completed. Follow-up should be performed depending on the significance of the audit findings. CAPA follow-up and subsequent effectiveness verification should be ensured by continued interaction between the auditor and auditee until mutual agreement has been met that the CAPA have been addressed.

10 Audit Certificate

The auditor (including the auditing department manager) should prepare an audit certificate at the request of the sponsor. The sponsor should attach the audit certificate to a clinical trial/study report of the targeted trial. The audit certificate should contain the following information: • Information that identifies the trial, such as the chemical name or identification code of the investigational drug, the trial title, and the protocol number. • The date of issuing the audit certificate. • The contents of the audit (e.g., subjects and date of the audit, and date of issuing the audit report). • The name(s), title and address of the auditor (s)(and the auditing department manager). • The name and workplace address of the auditee.

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