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
- 241 pages
- English
- PDF
- Available on iOS & Android
eBook - PDF
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Table of contents
- Cover
- Title Page
- Copyright Page
- Table of Contents
- Dedication
- Preface
- Acknowledgments
- 1: What Is a GMP or Quality Audit?
- 2: The Big Picture
- 3: Regulatory Requirements and Expectations for GMP Audits
- 4: Your Auditing Policy and SOP
- 5: Types of Audits
- 6: Audit Approaches
- 7: Auditor Qualifications and Skills
- 8: Phase I: Preparation
- 9: Phase II: Conduct the Audit
- 10: Interviewing Auditees
- 11: Phase III: Analyzing Audit Data
- 12: Phase IV: The Audit Report
- 13: Phase V: Follow-up and Closure
- 14: Auditing Vendors and Contractors
- 15: Being Audited
- References and Readings
- Appendix 1—American Society for Quality Control Code of Ethics
- Appendix 2—In Their Own Words: GMP and Quality Auditors Talk About Auditing
- Appendix 3—Resources
- James L. Vesper
- Index
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Yes, you can access Quality and GMP Auditing by James L. Vesper in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over 1.5 million books available in our catalogue for you to explore.