Main description:

This 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 title serves 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. It 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.

Contents:

Regulations. Terminology. Risk Assessment. Master and Project Planning. Design Qualification. Installation Qualification. Operational Qualification. Performance Qualification. Software and Computers. Validation. Data Review. Out-of-Specifications. Certified Reference Standards. People. Proficiency Testing. Audits. Appendix A: Glossary. Appendix B: Testing. Appendix C: SOP. Appendix D: Books. Appendix E: References