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Table of Contents
1. Milling & Charging 2 Chapter 2
Granulation 3. Compression 4. Sub-Coating 5. Membrane Coating 6. Drilling 7. Drying 8. Overcoating 9. Printing 10. Sorting & Packing 11. Capsule filling 12. Safe Handling of API & Drugs 13. Data Integrity Compliance 14. Guidelines for Statistical Procedure 15. Calibration 16. Clean-In-Place 17. Cleaning Validation 18. Manufacturing Process Validation 19. Risk Based Life Cycle Management 20. pFMEA Manufacturing Procedure 21. Analytical Methods Development, Validation, and Transfer Appendices