Establishing A CGMP Laboratory Audit System

A Practical Guide

Autor: David M. Bliesner

Limbă:

Legare: Copertă tare

Editura: John Wiley & Sons Inc

Disponibilitate: În depozitul extern

Expediem în 14-21 zile

762.68 lei

The first systematic, hands-on auditing guide for today's pharmaceutical laboratories In today's lit...

Informații despre carte

Autor

David M. Bliesner

Limbă

engleză

Legare

Carte - Copertă tare

Publicat

2006

Pagini

296

EAN

9780471738404

ISBN

0471738409

Enbook ID

04893581

Editura

John Wiley & Sons Inc

Greutate

560

Dimensiuni

162 x 236 x 19

Descriere completă

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.

S-ar putea să te intereseze

Clienții care au cumpărat această carte au mai cumpărat și

Cele mai căutate

Categories

Authors

Publishers

Produse

Produse

Cele mai căutate

Categories

Authors

Publishers

Produse

Produse

Establishing A CGMP Laboratory Audit System

A Practical Guide

Informații despre carte

Descriere completă

S-ar putea să te intereseze

Clienții care au cumpărat această carte au mai cumpărat și