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AMRH Standard Operating Procedures and Guidelines for Good Manufacturing Practice (GMP) Inspections – Inspector’s Playbook

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AMRH Standard Operating Procedures and Guidelines for Good Manufacturing Practice (GMP) Inspections – Inspector’s Playbook Exigences en Matière de Compétences, Cadre de Formation et d’Évaluation des Inspecteurs aux BPF - POS et Lignes Directrices

This document includes:

  1. Competence Requirements, Assessment Framework and Training for GMP Inspectors
  2. Inspectors Training Manual
  3. AMRH Guideline for Good Manufacturing Practice (GMP) Inspections
  4. Guidelines on Implementing Reliance and Information-Sharing Mechanisms
  5. Guidance Document on Remote-Virtual Good Manufacturing Practice (GMP)
  6. SOP for Scheduling of GMP Inspections
  7. SOP for Preparation for GMP Inspections
  8. SOP for Conducting GMP Inspections
  9. SOP for GMP Inspection Reporting
  10. SOP for GMP Compliance Status Determination
  11. SOP for GMP Inspection CAPA Review and Closure
  12. SOP for GMP Desk Review and Clearance
  13. SOP for AMRH GMP Inspections Activities Tracking