Manufacturing of Quality Oral Drug Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (Api)

ISBN-13: 9781032124735 / Angielski / Twarda / 2022 / 208 str.

Sam A. Hout

Opis

This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products.

Spis treści

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