Publisher: CRC Press
Year of Publication: 2016
Author(s) : Terry Jacobs and Andrew A. Signore
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.
This book 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 and lastly, enriches decision-making by emphasizing scope development, master planning, and clear design execution