RegOpsPro™GDP Self-Inspection Operating Model™
A practical model for defining the inspection universe, planning risk-based coverage, protecting independence, testing real execution, controlling findings and CAPA, and turning self-inspection into organisational learning.
The GDP self-inspection execution standard
Map the full GDP universe and create a justified programme rather than a generic annual checklist.
Assign competent independent reviewers, plan samples and test actual execution against current criteria.
Record objective observations, determine causes and hand formal investigation and CAPA into the QMS.
Trend coverage, recurrence, overdue actions and effectiveness so the programme improves control.
Understand programme design, good practice, common failure points and inspector challenge at each stage.
Create and manage individual inspections, findings, actions and effectiveness follow-up in organisation context.
Regulatory foundation and applicability
This model supports GDP self-inspection for human-medicines wholesale distribution. The programme should cover all aspects of GDP within a defined timeframe, include subcontracted activities, use competent and appropriately independent reviewers, record observations and follow CAPA through.
Source review: 22 September 2026. Confirm current licence conditions, GDP requirements and organisation procedures before making formal audit or CAPA decisions.
Put the self-inspection model into practice
Use the Practitioner Guide™ for judgement and the Self-Inspection Module to create and manage recurring inspection records, findings, actions and effectiveness follow-up.