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Self-inspection programme
A self-inspection programme shall be implemented covering all aspects of good distribution practice for veterinary medicinal products and compliance with this Regulation and procedures within a defined time frame.
Conduct and recording of self-inspections
1. Self-inspections may be divided into several individual self-inspections of limited scope. 2. Self-inspections shall be conducted in an impartial and detailed way by designated competent personnel. Audits by independent external experts may not be used as a substitute for self-inspection. 3. All self-inspections shall be recorded. Reports shall contain all the observations made during the inspection. A copy of the report shall be provided to the management and other relevant persons. 4. In the event that irregularities or deficiencies are observed, their cause shall be determined and the CAPA shall be documented and followed up. The effectiveness of the CAPA shall be reviewed.
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