1st Edition
GMP Compliance, Productivity, and Quality Achieving Synergy in Healthcare Manufacturing
Edited By Vinay Bhatt
Copyright 1998
524 Pages
by
CRC Press
524 Pages
by
CRC Press
Also available as eBook on:
Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and contract organizations across the globe, the... Read more
Chapters cover:
o Process Improvement & GMP Compliance, V. Bhatt
o Pharmaceutical Development, G. Fourman & T. Morris
o Process & Equipment Optimization, A. Kwong, D. Timms & K. Chiu
o Facilities & Support Systems Optimization, J. Chu, G. Cierpial &
A. Kwong
o SUPAC & Regulatory Consequences, S. Roy & S. Watson
o Laboratory Operation, D. Mulligan & C. Smith
o Validation, V. Bhatt, J. Basarke & E. Mittleberg
o Integrated Supply Chain Planning, N. Kapadia, Y. Chang & S. Moyer
o Outsourcing, P. Beaumier, P. Pickles & R. Joshi
o Inspection of Automated Systems, R. Perez & K. Pelley
o PAI Preparation, D. Mulligan, J. Goetz & A. Werner
o Regulations, Harmonization, & the Industry, J. Basarke & M. Hynes
o Pharmaceutical Quality, J. Nally & R. Kieffer
o Process Improvement & GMP Compliance, V. Bhatt
o Pharmaceutical Development, G. Fourman & T. Morris
o Process & Equipment Optimization, A. Kwong, D. Timms & K. Chiu
o Facilities & Support Systems Optimization, J. Chu, G. Cierpial &
A. Kwong
o SUPAC & Regulatory Consequences, S. Roy & S. Watson
o Laboratory Operation, D. Mulligan & C. Smith
o Validation, V. Bhatt, J. Basarke & E. Mittleberg
o Integrated Supply Chain Planning, N. Kapadia, Y. Chang & S. Moyer
o Outsourcing, P. Beaumier, P. Pickles & R. Joshi
o Inspection of Automated Systems, R. Perez & K. Pelley
o PAI Preparation, D. Mulligan, J. Goetz & A. Werner
o Regulations, Harmonization, & the Industry, J. Basarke & M. Hynes
o Pharmaceutical Quality, J. Nally & R. Kieffer
Biography
Vinay Bhatt
" ... an outstanding practical body of knowledge from leading U.S., Canadian and Swiss firms. The practical nature of this handbook, in conjunction with the many real-life examples it presents, makes it required reading for practitioners involved in the task of improving the balance between quality and productivity in the pharmaceutical industry. Those who succeed discover that both can be achieved simultaneously. The book presents several good ideas, examples and methods. "
-Ron S. Kenett, KPA Limited, in Quality Progress, ASQ
