000			01965nam a2200157Ia 4500
008			140223b2006 xxu||||| |||| 00| 0 eng d
020			_a9780471738404 _c0.00
082			_a615.152 _bBLI
100			_aBliesner, David M.
245			_aEstablishing a cGMP Laboratory Audit System: A Practical Guide
260			_aNew York _bWiley-Interscience _c2006
300			_a277p
500			_aPCG00086 The first systematic, hands-on auditing guide for today's pharmaceutical laboratories In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future requirements. Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to: * Improve current compliance * Demonstrate sustainable compliance * Produce data for federal inspections * Avoid regulatory action Enhanced with detailed checklists and a wealth of practical and flexible auditing tools on CD-ROM, this book provides an ideal resource for new and future laboratory personnel, and an excellent means for keeping existing industry practitioners up to date on the nuances of operating a consistently compliant pharmaceutical laboratory.
890			_aUSA
995			_ABLI _B005082 _CMPH-PHA _D4317.60 _E0 _F049 _G34646 _H0 _I0.00 _L20061019 _M1 _UC _W20061114 _XEducational Book Centre _ZReference
999			_c15504 _d15504