Sterile Product Facility Design and Project Management

Jeffrey N. Odum (Autor)

Buch | Hardcover

466 Seiten

1996
Interpharm Press Inc (Verlag)
978-1-57491-020-9 (ISBN)

Infos

The design and construction of a sterile product facility for the manufacture of pharmaceuticals is a complex undertaking that involves many considerations not typically encountered when building more traditional pharmaceutical facilities. Focusing on proven fundamentals, this book explains the unique facility design needs of sterile product manufacturing. Containing numerous charts, graphs, tables, and sample forms, the author covers sterile facility design and project management from A to Z. Topics include: project formation, defining the project team, facility programming, project control and costing, and GMP requirements and their impact on architectural design and construction.

Inhalt

Facility Project Management Essentials
Project Formation
Defining the Project Team
Facility Programming
Project Control and Costing
GMP Requirements and Their Impact on Architectural Design and Construction
Commissioning
Validation
Quality Management to Meet Regulatory Requirements
Regulatory Concerns including Establishment License Applications Requirements for Biologic Facilities
Containment Concerns
Multi-product Facilities for Biologics
Contract Formulation
Future Trends: Barrier Technology, Outsourcing, & Industry Restructuring

Produkt-Details

• Erscheint lt. Verlag: 1.11.1996
• Verlagsort: London
• Sprache: englisch
• Maße: 216 x 279 mm
• Gewicht: 2041 g
• Themenwelt: Studium ► 2. Studienabschnitt (Klinik) ► Pharmakologie / Toxikologie
• ISBN-10: 1-57491-020-5 / 1574910205
• ISBN-13: 978-1-57491-020-9 / 9781574910209
• Zustand: Neuware