Establishing A CGMP Laboratory Audit System
A Practical Guide
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Beschreibung
The first systematic, hands-on auditing guide for today'spharmaceutical laboratories
In today's litigious environment, pharmaceutical laboratories aresubject to ever stricter operational guidelines as mandated by theFDA, and must be able to establish and demonstrate sustainableoperational practices that ensure compliance with the current goodmanufacturing practice (CGMP) regulations. David Bliesner'sEstablishing a CGMP Laboratory Audit System: A Practical Guide isdesigned to provide laboratory supervisors and personnel with astep-by-step, hands-on audit system that they can rely on to ensuretheir facility remains compliant with all current and futurerequirements. Focusing on a "team approach," the author usesdetailed flowcharts, checklists, and descriptions of the auditingprocess to help readers develop a new audit system or upgrade theircurrent 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 andflexible auditing tools on CD-ROM, this book provides an idealresource for new and future laboratory personnel, and an excellentmeans for keeping existing industry practitioners up to date on thenuances of operating a consistently compliant pharmaceuticallaboratory.
Autor*in
David M. Bliesner
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