Active Pharmaceutical Ingredients

Development, Manufacturing, and Regulation, Second Edition

Buch | Hardcover

456 Seiten

2009 | 2nd edition
Crc Press Inc (Verlag)
978-1-4398-0336-3 (ISBN)

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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.

Stanley Nusim

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.

Erscheint lt. Verlag	23.12.2009
Reihe/Serie	Drugs and the Pharmaceutical Sciences
Zusatzinfo	35 Illustrations, black and white
Verlagsort	Bosa Roca
Sprache	englisch
Maße	152 x 229 mm
Gewicht	680 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Medizin / Pharmazie ► Pflege
	Medizin / Pharmazie ► Pharmazie
	Naturwissenschaften ► Biologie
	Technik ► Umwelttechnik / Biotechnologie
ISBN-10	1-4398-0336-6 / 1439803366
ISBN-13	978-1-4398-0336-3 / 9781439803363
Zustand	Neuware