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 contributing authors bring readers a combined 450+ years of hands-on experience. They offer thought-provoking questions to help readers diagnose their company's challenges, needs, and available options, all with the single purpose of achieving their ultimate goals: quality, high productivity, and profitability.
" … 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
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 &
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