Glossary
Self-Inspection
Also writteninternal auditquality audit
The site's own periodic assessment of GMP compliance and of the effectiveness of the quality system.
Source · PIC/S PE 009-17, Part I, Chapter 9, Self Inspection
Details
Self-inspection independently confirms whether the quality system actually operates in line with GMP requirements and the company's own procedures, and looks for opportunities to improve. Inspections cite the absence of a risk-based plan or of independence for the inspectors, and repeated findings that were not carried into CAPA and effectiveness verification. Look at the annual inspection plan, the checklists and reports, the classification of findings, CAPA due dates and effectiveness checks, and management review.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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The major deficiencies were found in the areas of (1) Self-inspection program was found to be inadequate and (2) Several bad documentation practices were observed throughout the course of the inspection.
EMA · EU GMP NCR (EudraGMDP) · 2024-01-19 -
We acknowledge your actions regarding inadequate skin coverage posing a contamination risk to sterile drug products, including internal training to SOP 0003.00 with emphasis on mirror self-inspection.
FDA · FDA Warning Letter · 2026-03-17
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
PIC/S PE 009-17, Part I, Chapter 9, Self InspectionGRM Regulatory Glossary
243 GMP terms in one place
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