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.
Reihe
Auflage
Sprache
Verlagsort
Verlagsgruppe
Zielgruppe
Für Beruf und Forschung
Pharmaceutical scientists, manufacturers, and engineers; analytical chemists; quality assurance and regulatory personnel; and upper-level undergraduate and graduate students in these disciplines.
Editions-Typ
Illustrationen
35 s/w Abbildungen
35 b/w images
Dateigröße
ISBN-13
978-1-4398-0339-4 (9781439803394)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
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.
