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

Main class

543

Sub class

.0685

Cutter no

H8624v

ISBN

084938267x

Link To Document

https://lib.ui.ac.ir/dl/search/default.aspx?Term=2471&Field=0&DTC=14