Validation and Qualification in Analytical Laboratories: 2nd Edition (e-Book) book cover

Validation and Qualification in Analytical Laboratories

2nd Edition

CRC Press

288 pages

Purchasing Options:$ = USD
Hardback: 9780849382673
pub: 2007-07-23
eBook (VitalSource) : 9780429191220
pub: 2007-07-23
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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

Table of 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

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology