Validation and qualification in analytical laboratories
Huber, Ludwig,
Validation and qualification in analytical laboratories Ludwig Huber. - 2nd ed. - New York : Informa Healthcare, 2007.. - v, 303 p. : ill. ; 24 cm.
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.
9780849382673 (hbk. : alk. paper)
Chemistry, Analytic--Quality control.
Chemical laboratories--Standards.
Chemistry, Pharmaceutical--standards.
Chemistry, Analytical--standards.
Drug Industry--standards.
Laboratories--standards.
Quality Control.
543.0685 / HUB
Validation and qualification in analytical laboratories Ludwig Huber. - 2nd ed. - New York : Informa Healthcare, 2007.. - v, 303 p. : ill. ; 24 cm.
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.
9780849382673 (hbk. : alk. paper)
Chemistry, Analytic--Quality control.
Chemical laboratories--Standards.
Chemistry, Pharmaceutical--standards.
Chemistry, Analytical--standards.
Drug Industry--standards.
Laboratories--standards.
Quality Control.
543.0685 / HUB
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