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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.
List 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
About the author
Dr. Sam A. Hout is a chartered chemical engineer and certified in business management by the American Production and Inventory Control Society (APICS). He also is a member of the International Society of Pharmaceutical Engineers (ISPE) and specializes in process engineering and business process improvement. He received his education and training in the UK (Ph.D. Chemical Engineering, University of Bath) and in the United States (MBA, University of California). For the past 20 years in aseptic manufacturing, he held the position of Sr. Director of Engineering, project management, and technology process transfers at SIEGFRIED Pharmaceuticals. Previously, Dr. Hout has held the position of Sr. Manager of Engineering at TEVA Pharmaceuticals, parenteral medicines in Irvine, California. These specialty divisions produced sterile injectable drugs for hospital institutional markets worldwide.
Prior to assuming the position at Teva, Dr. Hout was Director of Operations at PHENOMENEX, the leading global company in HPLC (High Performance Liquid Chromatography) for drug separation and analysis. During the past thirty years, Dr. Hout has helped to guide leading companies in technical positions such as J&J, Medtronic, and Fischer Scientific in developing and producing medical devices and diagnostic standards that combat disease and promote healthier lives. In working with a global market, Dr. Hout travels frequently throughout the United States, Europe and the Far East.
Summary
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.
