01692nam a2200241Ia 4500 CTU_162474 210402s9999 xx 000 0 und d 105 343.7307 B649 Bliesner, David M. Establishing a CGMP laboratory audit system : a practical guide David M. Bliesner Hoboken, N.J. Wiley-Interscience 2006 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 Pharmaceutical industry,Drugs,Drug Industry,Ngành công nghiệp dược phẩm Law and legislation,standards United States,United State,United States,Hoa Kỳ Nguyên Trung tâm Học liệu Trường Đại học Cần Thơ