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 phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools will help you prepare checklists and standards so audits become more effective, consistent, and standardized. The book includes profiles of seasoned professionals in drug and device auditing, who share their experiences (the good and the bad)!
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.
Vesper, James L.