Training Course Plan
GMP According to WHO Guidelines
(5-Day Program)
Course Overview
• Target Audience:
• • Quality Inspectors, Technicians, and
Production Staff
• Duration:
• • 5 Days (4 sessions per day = 20 sessions
total)
Training Schedule Overview
• Day 1: GMP Basics, QMS, Facility Design,
Personnel
• Day 2: Documentation, Warehousing, Temp
Mapping, Cleaning Validation
• Day 3: Production, Line Clearance, Water
System, Calibration
• Day 4: QC, OOS, Validation Plan, HVAC
• Day 5: Self-Inspection, Complaints, CAPA, Case
Study
Day 1 – Core Concepts
• 1. Introduction to GMP & WHO Guidelines
• 2. Quality Management System (QMS)
• 3. GMP for Buildings and Facility Design
• 4. Personnel and Training
Day 2 – Warehousing and
Validation
• 5. Documentation and Records
• 6. Raw Material Handling & Sampling
• 7. Warehousing & Temperature Mapping
• 8. Cleaning Validation
Day 3 – Production & Utilities
• 9. Production & In-Process Control
• 10. Cross Contamination & Line Clearance
• 11. Water Treatment Unit
• 12. Equipment Qualification (IQ, OQ, PQ)
Day 4 – QC and Validation
• 13. Quality Control & Laboratory Practices
• 14. Handling Out-of-Spec (OOS) Results
• 15. Validation Master Plan (VMP)
• 16. HVAC & Environmental Monitoring
Day 5 – Audits and Final Review
• 17. Self-Inspection & Internal Audits
• 18. Complaints & Product Recall
• 19. Deviation, Change Control & CAPA
• 20. Final Review + Workshop / Case Study