Establishing A CGMP Laboratory Audit System 在線電子書 pdf 下載 txt下載 epub 下載 mobi 下載 2024

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Bliesner, David M. 作者

John Wiley & Sons Inc

譯者

2006-4 出版日期

277 頁數

846.00元價格

HRD

叢書系列

9780471738404 圖書編碼

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發表於2024-09-21

Establishing A CGMP Laboratory Audit System 在線電子書 epub 下載 mobi 下載 pdf 下載 txt 下載 2024

Establishing A CGMP Laboratory Audit System 在線電子書 epub 下載 pdf 下載 mobi 下載 txt 下載 2024

Establishing A CGMP Laboratory Audit System 在線電子書 pdf 下載 txt下載 epub 下載 mobi 下載 2024

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Establishing A CGMP Laboratory Audit System 在線電子書 pdf 下載 txt下載 epub 下載 mobi 在線電子書下載

Establishing A CGMP Laboratory Audit System 在線電子書圖書描述

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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