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.
Validation and Qualification in Analytical Laboratories,...
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a great single reference containing all you ever wanted to know about validating and verifying assay or equipment performance.
Doody’s Review - Valerie L. Ng, PhD, MD
Doody’s Review - Valerie L. Ng, PhD, MD
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Key Phrases - Statistically Improbable Phrases (SIPs):
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analytical laboratories, audit questions, quality risk management, quality systems approach, training master plan, system suitability testing, internal reference material, system suitability tests, validation master plan, proficiency testing schemes, equipment qualification, operational qualification, audit items, design qualification, intermediate precision, installation qualification, baseline noise, performance qualification, wavelength accuracy Key Phrases - Capitalized Phrases (CAPs): (learn more)
Validation of Analytical Methods, Summary Recommendations, United States, Good Manufacturing Practice, Handling Out-of-Specification Situations, Problems Found, Factors Related, Same Different Different, Peer-Verified Methods, Good Laboratory Practice, Laboratory Audits Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
analytical laboratories, audit questions, quality risk management, quality systems approach, training master plan, system suitability testing, internal reference material, system suitability tests, validation master plan, proficiency testing schemes, equipment qualification, operational qualification, audit items, design qualification, intermediate precision, installation qualification, baseline noise, performance qualification, wavelength accuracy Key Phrases - Capitalized Phrases (CAPs): (learn more)
Validation of Analytical Methods, Summary Recommendations, United States, Good Manufacturing Practice, Handling Out-of-Specification Situations, Problems Found, Factors Related, Same Different Different, Peer-Verified Methods, Good Laboratory Practice, Laboratory Audits Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
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