Quality and GMP Auditing: Clear and Simple

✍ Scribed by James L. Vesper (Author)

Publisher: CRC Press
Year: 1997
Leaves: 241
Edition: 1
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

This guidebook provides proven methods and techniques for performing effective audits that serve your department, your company, and you. Topics covered relate to the four key competencies essential for successful GMP audits. Includes the rationale for auditing as an important quality tool, along with the audit cycle, broken into five distinct phase

✦ Table of Contents

What Is a GMP or Quality Audit? Big Picture. Regulatory Requirements & Expectations for GMP Audits. Your Auditing Policy & SOP. Types of Audits. Audit Approaches. Auditor Qualifications & Skills. Phase I: Preparation. Phase II: Conduct the Audit. Interviewing Auditees. Phase III: Analyzing the Audit Data. Phase IV: The Audit Report. Phase V: Follow-up & Closure. Auditing Vendors & Contractors. Being Audited.

✦ Subjects

Bioscience;Pharmaceutical Science;Analysis & Pharmaceutical Quality

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