Nusim Active Pharmaceutical Ingredients

Development, Manufacturing, and Regulation
2. Auflage 2016
ISBN: 978-1-4398-0339-4
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 456 Seiten

Reihe: Drugs and the Pharmaceutical Sciences

Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of Active Pharmaceutical Ingredients (APIs) globally.

This Second Edition brings you 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.

New features include:

- chapters on safety, efficacy, and environmental/regulatory requirements

- analysis of the recent movement of API manufacturing from the US and Europe to countries such as India and China

- discussions on both US and international regulatory requirements

- information about the FDA’s intensified foreign inspection program

- data on multi-use and flexible design facilities

- the shift from maintenance scheduling to built-in reliability

Zielgruppe

Pharmaceutical scientists, manufacturers, and engineers; analytical chemists; quality assurance and regulatory personnel; and upper-level undergraduate and graduate students in these disciplines.

Autoren/Hrsg.

Nusim, Stanley

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

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.