Audit and Control for Healthcare Manufacturers: A Systems-Based Approach

Table of Contents:

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1. The Purpose of Auditing
2. Quality Management Systems
3. GMP Requirements for Auditing
4. ISO 9001 and the Audit Process
5. Different Types of Audits and Inspections
6. Systems-Based Audits and Inspections
7. Managing the Audit Function and Defining Metrics
8. Auditor Training and the Characteristics of a Good Auditor
9. Introduction to Risk Management
10. Risk Based Approach to Quality Auditing
11. Auditor Techniques
12. The Role of the Auditee: Running and Responding to Audits
13. Documenting and Reporting Audits
14. Best Practices for Laboratory OOS Investigations
15. Microbial Data Deviations
16. Control and Use of Reference Standards
17. Auditing Sterile Pharmaceutical Facilities
18. Self-Inspection in Pharmaceutical Facilities as a Case Study
19. Draft External Audit Report for Assessing a Manufacturer for Prions
20. Computerized Systems Audits and Data Integrity Requirements
21. Auditing Cleanrooms in Pharmaceutical Facilities
22. Auditing Culture Media Suppliers
23. Auditing and Control of the Laboratory Function
24. Auditing the Microbiology Laboratory
25. Audit Templates

About the Authors

Dr. Tim Sandle has over 25 years' experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology and Sterility Assurance at Bio Products Laboratory, UK and a visiting tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester. In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control, including the Pharmaceutical Microbiology Interest Group (Pharmig) and PDA technical working groups. He is also a member of several editorial boards for scientific journals. Dr. Sandle has written over 600 book chapters, peer reviewed papers and technical articles relating to microbiology. These include the DHI/PDA books Sterility Testing of Pharmaceutical Products, Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies, Cleanroom Microbiology, Aseptic and Sterile Processing: Control, Compliance and Future Trends, and Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers, as well as the books Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control and Biocontamination Control for Pharmaceuticals and Healthcare.

Jennifer Sandle is an experienced auditor of quality systems (GMP and ISO 9001) and laboratory operations. She is the Quality Assurance Manager at the National Institute of Biological Standards and Control (NIBSC), which is part of the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). Prior to working in QA, Jennifer worked as a biomedical scientist and held roles in microbiological method validation and laboratory management.