GMP Compliance, Productivity, and Quality : Achieving Synergy in Healthcare Manufacturing

ISBN-13: 9781574910773 / Angielski / Twarda / 1998 / 524 str.

Bhatt Vinay

Opis

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.

Spis treści

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 autorze

Vinay Bhatt