Validation and qualification in analytical laboratories
Author Statement
Ludwig Huber
Edition
2nd ed
Publication
Informa Healthcare
Publication Year
c2007
Collation
v, 303 p. ill.
Notes
Includes bibliographical references (p. 281-297) and index. , Introduction -- Regulations, standards, and guidelines -- Terminology and validation overview -- Risk-based validation and qualification -- Master and project planning for equipment and computer systems -- Design qualification -- Installation qualification -- Operational qualification -- Performance qualification and maintenance -- Special considerations for software and computer systems -- Validation of analytical methods -- Data review and validation and evaluation of uncertainty -- Handling out-of-specification situations -- (Certified) reference standards -- People -- Proficiency testing for external laboratory qualification -- Audits
Subject
Chemistry, Analytic , Chemical laboratories , Chemistry, Pharmaceutical , Chemistry, Analytical , Drug Industry , Laboratories , Quality Control
