1. Introduction -- 2. Concept of qualification/validation -- 3. Revalidation -- 4. Facility description -- 5. Description of building -- 6. Equipment description -- 7. HVAC description -- 8. Utilities descriptions -- 9. Validation program overview -- 10. Calibration program summary -- 11. Preventive maintenance program summary -- 12. Key standard operating procedures (SOPs) -- 13. Validation of building -- 14. Validation of utility systems -- 15. Process description for dry production facility : building A -- 16. Process description for liquid and semisolid production facility : building B -- 17. Process description for parenterals production facility : building C -- 18. Qualification of process equipment -- 19. Validation of support processes -- 20. Quality assurance/control laboratory validation -- 21. cGMP procedures and programs -- 22. Validation schedule -- 23. Drawings for ABC pharmaceutical plant.