Self-Inspections

Requirements for a self-inspection programme.

9.1 Self-inspection programme

  1. Self-inspections must be conducted to monitor implementation and compliance with good distribution practice principles.
  2. The self-inspection programme must cover all aspects of good distribution practice and compliance with the regulations, the Good Distribution Practice for Veterinary Medicines in Great Britain document and procedures within a defined time frame (minimum annually) and be recorded.

9.2 Conduct and recording of self-inspections

  1. Self-inspections may be divided into several individual self-inspections of limited scope. All areas must be inspected within the defined timeframe.
  2. All self-inspections must be recorded. Reports must contain all the observations made during the inspection. A copy of the report must be provided to the management and other relevant persons.
  3. In the event that irregularities or deficiencies are observed, their cause must be determined and the Corrective Action, Preventative Action (CAPA) be documented and followed up. The effectiveness of the CAPA must be reviewed and completed CAPAs must be signed off by the WQP.
  4. Self-inspections must be conducted in an impartial and detailed way by designated competent company personnel. However, each wholesale qualified person must conduct at least one self-inspection covering all aspects of good distribution practice over the course of a year. Audits by independent external experts may also be useful but may not be used as a substitute for self-inspection.