Active Pharmaceutical Ingredients
Development, Manufacturing, and Regulation
Seiten
2005
Crc Press Inc (Verlag)
978-0-8247-0293-9 (ISBN)
Crc Press Inc (Verlag)
978-0-8247-0293-9 (ISBN)
- Titel erscheint in neuer Auflage
- Artikel merken
Zu diesem Artikel existiert eine Nachauflage
Active Pharmaceutical Ingredients
Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. This guide offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety.
Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. This guide offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety.
Introduction. Process Development. Technology Transfer. Plant Design & Construction. Regulatory Requirements. Process Validation. Quality Assurance and Control. Plant Operations. Materials Management. Plant Maintenance
| Erscheint lt. Verlag | 25.5.2005 |
|---|---|
| Reihe/Serie | Drugs and the Pharmaceutical Sciences |
| Zusatzinfo | 15 Tables, black and white; 48 Illustrations, black and white |
| Verlagsort | Bosa Roca |
| Sprache | englisch |
| Maße | 152 x 229 mm |
| Themenwelt | Medizin / Pharmazie ► Pflege |
| Technik | |
| ISBN-10 | 0-8247-0293-X / 082470293X |
| ISBN-13 | 978-0-8247-0293-9 / 9780824702939 |
| Zustand | Neuware |
| Haben Sie eine Frage zum Produkt? |
Mehr entdecken
aus dem Bereich
aus dem Bereich
Anregungen für kreatives Handeln
Buch | Softcover (2023)
Kohlhammer (Verlag)
CHF 33,55
nach Expertenstandards, MD-Kriterien des neuen BI und Indikatoren der …
Buch | Softcover (2023)
Kohlhammer (Verlag)
CHF 39,95
Training und Transfer Pflege, Heft 3 (Print inkl. eLehrmittel)
Buch | Softcover (2023)
hep verlag
CHF 29,00
