Description

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. 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.

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.

Langue

en

Version

Couverture rigide

Date de sortie initiale

23 mai 2006

Nombre de pages

296

Illustrations

Non

Traduction

Titre original

Establishing a Cgmp Laboratory Audit System: A Practical Guide

Personnes impliquées

Auteur principal

David M. Bliesner

Editeur principal

Wiley-Interscience

Informations sur le fabricant

Nom du fabricant

Easy Access System Europe Oü, 16879218

Adresse du fabricant

– 10621 – – EE

Adresse électronique du fabricant

[email protected]

Autres spécifications

Hauteur de l’emballage

19 mm

Hauteur du produit

19 mm

Largeur d’emballage

159 mm

Largeur du produit

160 mm

Livre d‘étude

Non

Longueur d’emballage

235 mm

Longueur du produit

241 mm

Poids de l’emballage

567 g

Police de caractères extra large

Non

Édition

New title

EAN

EAN

9780471738404

Sécurité des produits

Opérateur économique responsable dans l’UE

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Disponibilité

Disponible à l’adresse suivante

Langue

Anglais

Type de livre

Hardcover