Internal Audit (Self-Inspection)
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Internal audit — called self-inspection in the GMP world — is the planned, independent examination of the organization's own activities and quality system to verify compliance with requirements and to identify weaknesses before an external inspector or a failure does. It is conducted to a program and schedule by suitably trained, independent personnel, documented with findings and corrective actions, and followed up to closure. It is a proactive assurance mechanism: the system checking itself.
The essential attribute is independence: an auditor should not be assessing their own work, or the audit's value as an objective check collapses. Findings feed the CAPA system and are an input to management review, closing the loop between detection and correction.
A mature self-inspection program is candid — it surfaces real problems rather than confirming that everything is fine — because the alternative is that those problems are found later by a regulator or a defect.
- —Planned, independent examination of one's own quality system
- —Conducted to a documented program and schedule by trained, independent auditors
- —Findings drive CAPA and feed management review
- —Independence and candor are what make it worthwhile
EU GMP Chapter 9 (self-inspection); ISO 13485 and ISO 19011 internal audit; ICH Q10 internal audit.
Frequently asked questions
What is Internal Audit (Self-Inspection)?
Internal audit — called self-inspection in the GMP world — is the planned, independent examination of the organization's own activities and quality system to verify compliance with requirements and to identify weaknesses before an external inspector or a failure does. It is conducted to a program and schedule by suitably trained, independent personnel, documented with findings and corrective actions, and followed up to closure. It is a proactive assurance mechanism: the system checking itself.
Which regulations cover Internal Audit (Self-Inspection)?
EU GMP Chapter 9 (self-inspection); ISO 13485 and ISO 19011 internal audit; ICH Q10 internal audit.