Good Design Practices for GMP Pharmaceutical Facilities: 2nd Edition (Hardback) book cover

Good Design Practices for GMP Pharmaceutical Facilities

2nd Edition

Edited by Terry Jacobs, Andrew A. Signore

CRC Press

518 pages | 212 Color Illus.

Purchasing Options:$ = USD
Hardback: 9781482258905
pub: 2016-06-27
$195.00
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eBook (VitalSource) : 9781315372242
pub: 2016-08-19
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Description

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.

Table of Contents

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.

About the Series

Drugs and the Pharmaceutical Sciences

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Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
MED072000
MEDICAL / Pharmacy