ABSTRACT

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

chapter 1|12 pages

What Is a GMP or Quality Audit?

chapter 2|6 pages

The Big Picture

chapter 4|8 pages

Your Auditing Policy and SOP

chapter 5|10 pages

Types of Audits

chapter 6|28 pages

Audit Approaches

chapter 7|12 pages

Auditor Qualifications and Skills

chapter 8|20 pages

Phase I: Preparation

chapter 9|16 pages

Phase II: Conduct the Audit

chapter 10|8 pages

Interviewing Auditees

chapter 11|10 pages

Phase III: Analyzing Audit Data

chapter 12|20 pages

Phase IV: The Audit Report

chapter 13|10 pages

Phase V: Follow-up and Closure

chapter 14|10 pages

Auditing Vendors and Contractors

chapter 15|14 pages

Being Audited