This document includes:
- Competence Requirements, Assessment Framework and Training for GMP Inspectors
- Inspectors Training Manual
- AMRH Guideline for Good Manufacturing Practice (GMP) Inspections
- Guidelines on Implementing Reliance and Information-Sharing Mechanisms
- Guidance Document on Remote-Virtual Good Manufacturing Practice (GMP)
- SOP for Scheduling of GMP Inspections
- SOP for Preparation for GMP Inspections
- SOP for Conducting GMP Inspections
- SOP for GMP Inspection Reporting
- SOP for GMP Compliance Status Determination
- SOP for GMP Inspection CAPA Review and Closure
- SOP for GMP Desk Review and Clearance
- SOP for AMRH GMP Inspections Activities Tracking