Active Pharmaceutical Ingredients
Development, Manufacturing, and Regulation, Second Edition
Series: Drugs and the Pharmaceutical Sciences; 205;
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Estimated delivery time: In stock at the publisher, but not at Prospero's office. Delivery time approx. 3-5 weeks.
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Product details:
- Edition number 2, New edition
- Publisher CRC Press
- Date of Publication 23 December 2009
- ISBN 9781439803363
- Binding Hardback
- No. of pages456 pages
- Size 229x152 mm
- Weight 771 g
- Language English
- Illustrations 35 Illustrations, black & white 0
Categories
Short description:
To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. This book is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. This secoond edition brings readers up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.
MoreLong description:
To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally.
Topics include:
- Safety, efficacy, and environmental/regulatory requirements
- Analysis of the recent movement of API manufacturing from the U.S. and Europe to countries such as India and China
- The FDA’s intensified foreign inspection program
- Multi-use and flexible design facilities
- The shift from maintenance scheduling to built-in reliability
This second edition focuses on the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the United States and international regulatory agencies.
MoreTable of Contents:
1. Introduction. 2. Process Development, Scaleup, and Design. 3. Technology Transfer and First Manufacture. 4. Plant Design and Construction. 5. Regulatory Requirements: US. 6. Regulatory Requirements: Outside US. 7. Process Validation. 8. Quality Assurance and Control. 9. Environmental Control. 10. Safety. 11. Plant Operations. 12. Bulk Sterile Manufacturing. 13. Materials Management. 14. Plant Maintenance.
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