Validation and Qualificatiion in Analytical Laboratories, Second edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards.

With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory, this handbook is as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process.

Validation and Qualificatiion in Analytical Laboratories also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

A practical source for understanding and managing laboratory validation and qualification processes, this guide:

• incorporates new chapters on risk-based validation and qualification and action plans for laboratories
• provides complete coverage of regulations and quality standards, including the new FDA 21 CRF Part 11 standard, ISO Standard 17025, and all major international standards
• includes several appendices presenting detailed real world case studies, testing procedures, and a glossary

Contents

1. Regulations
2. Terminology
3. Risk Assessment
4. Master and Project Planning
5. Design Qualification
6. Installation Qualification
7. Operational Qualification
8. Performance Qualification
9. Software and Computers
10. Validation
11. Data Review
12. Out-of-Specifications
13. Certified Reference Standards
14. People
15. Proficiency Testing
16. Audits

Appendices

• Glossary
• Testing
• SOP
• Books
• References

Index

click here to see books • videos • cd-roms of related interest