GMP Validation: A Guide to International Regulatory Requirements
- Published
- Sep 2024
- ISBN
- 978-1-917195-05-8
- Pages
- 650
- PDA Item Number
- 7953
- Format
- PDF Single User
- Member Price
- $269.00
- Nonmember Price
- $299.00
- Government Price
- $299.00
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Within the pharmaceutical and healthcare sector, validation and qualification form an important part of the quality system. However, understanding the differences between different regulatory agencies and the recommendations of different standards can be a bewildering project. This book seeks to provide a map and a compass for navigating the choppy waters of international regulations.
GMP Validation provides a text for those who need to assess validation and ensure that validation is conducted according to current GMP. These include the validation manager and personnel engaged in validation activities; quality assurance; quality control; R&D; and production personnel. Some of the scientific aspects will also appeal to students, especially those working within or aspiring to enter the pharmaceutical sector. The book also serves as a good starting point for those who are tasked with auditing validation systems or items of equipment or processes.
This comprehensive handbook is comprised of 30 chapters which are divided into two parts. The first part is dedicated to the management process, with an emphasis upon appropriate formality and risk-based approaches. The second part focuses on case studies, providing an overview of different GMPs and standards for different areas of validation and qualification.The book concludes with four useful appendicesproviding templates to aid the reader.
Table of Contents
Part A: Essential tools for the
validation manager
1. Qualification, Validation and the Formalised
Approach
2. Validation Documentation
3. Hazard Identification and
Assessment of Risk
4. Validation Project Management and Risk-based Problem
Solving
5. The V-model and the Lifecycle Approach to Validation
6. Quality
Risk Management and the Validation Process
7. Data and Statistics for the
Validation Manager
8. Validation Errors: Concept and Case Study
9.
Calibration Process and Setting Calibration Criticality
10. Setting the
Standards for New Equipment Purchases
11. Process Validation: Maintaining
Quality and Compliance
Part B:
Case studies and GMP concepts for validation
12. Audit and validation requirements of single-use
technologies
13. Containment system integrity: microbial challenges for
sterile products
14. Cleanroom design, commissioning and verification
15.
Qualification of disinfectants
16. Utility Design and Qualification for
Efficient Pharmaceutical Operations
17. Pharmaceutical Water Systems
18.
Equipment Design: Assessing Cleaning and Hygiene
19. Autoclaves and Steam
Sterilisation
20. Pure Steam for Sterilisation
21. Cleaning Validation:
Balancing GMPs and Risk
22. Compressed Air and Other Gases
23. Data
Loggers and Temperature Mapping
24. Microbiological Method Validation
25.
Data Integrity and Qualification
26. Isolator Sterility Validation
27.
Analytical Method Development
28. Analytical Method Transfer
29.
Computerised System Software Validation
30. Sterile
Filter Validation
Part C:
Appendices
Appendix 1:
Validation Master Plan.
Appendix 2: IQ Protocol.
Appendix 3: OQ
protocol.
Appendix
4: New equipment risk assessment.
About the Authors
Tim Sandle originally trained as a parasitologist before moving into microbiology.He took first degrees in microbiology and politics, and then proceeded to study for a master’s degree and a PhD part-time. Tim is currently Head of GxP Compliance and Sterility Assurance at Bio Products Laboratory. He is additionally a visiting tutor at the University of Manchester and University College London lecturing in pharmaceutical microbiology. He is a longstanding committee member of Pharmig and has served on several other international committees and editorial boards.Tim has written a number of books papers, and technical articles relating to GxP concerns, microbiology and contamination control.