Good Design Practices for GMP Pharmaceutical Facilities

ISBN-13: 9781482258905 / Angielski / Twarda / 2016 / 518 str.

Andrew A. Signore; Terry Jacobs; Andrew A. Signore

Opis

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Spis treści

Pharmaceutical Industry Profile. Current Good Manufacturing Practices. Master Planning Legacy Facilities. Architecture. Mechanical Utilities. High Purity Water. Automation and Process Controls. Validation and Facility Design. Process Engineering. Oral Solid Dosage Facilities. Sterile Manufacturing Facilities. Biotechnology Facilities. API Facilities. Compliance Codes and Standards. Containment / Isolation. Occupational Health and Safety. Technology Transfer. Sustainability and LEED for Manufacturing Facilities. Support Laboratories. Packaging / Warehousing.

O autorze

Terry Jacobs, Andrew A. Signore