Good Design Practices for GMP Pharmaceutical Facilities, Second Edition (English) torrent

Good Design Practices for GMP Pharmaceutical Facilities, Second Edition
(English)





Auteur : Terry Jacobs, Andrew A. Signore
ISBN : 9781482258905
Nombre de page :  518 Pages
Date de sortie : 27 Juin 2016



Features
Spans a wide range of topics central to the successful performance of pharmaceutical oral solid, sterile product, bioprocess, active pharma ingredient, clinical material and regulated facilities.
Presents essential background information and solutions to common challenges in the layout and formation of manufacturing facilities that must comply with current codes, statutes, and regulations in the industry
Includes practical suggestions that illustrate best practices in the planning and delivery of facilities that perform and conform to current regulatory requirements and business imperatives
Enriches decision-making by emphasizing scope development, master planning, and clear design execution

Summary
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.


Langue : Anglais



Taille totale : 21 Mo