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Establishing a CGMP Laboratory Audit System – A Practical Guide +CD

Autor DM Bliesner
en Limba Engleză Hardback – 22 mai 2006
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.
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Specificații

ISBN-13: 9780471738404
ISBN-10: 0471738409
Pagini: 304
Dimensiuni: 162 x 236 x 19 mm
Greutate: 0.56 kg
Editura: Wiley
Locul publicării:Hoboken, United States

Public țintă

Laboratories and laboratory staff which are regulated by the government and supervisors and QA personnel of pharmaceutical and biopharmaceutical companies.

Cuprins


Descriere

Establishing a CGMP Laboratory Audit System: A Practical Guide guides the reader through establishing a Current Good Manufacturing Practices laboratory audit system using detailed flowcharts, checklists, and descriptions of the process. Templates and checklists on a CD-ROM provide for easy use and modification in the laboratory.