عنوان

Validation and qualification in analytical laboratories /

084938267X

9780849382673

b757536

Validation and qualification in analytical laboratories /

[Book]

Ludwig Huber.

2nd ed.

New York :

Informa Healthcare,

©2007.

v, 303 pages :

illustrations ;

24 cm

Includes bibliographical references (pages 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.

0

"This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. This title serves as a complete source to the subject with comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory, and explains how to develop and implement a validation strategy for routine, nonroutine, 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."--BOOK JACKET.

Chemical laboratories-- Standards.

Chemistry, Analytic-- Quality control.

Chemistry Techniques, Analytical-- standards.

Chemistry, Pharmaceutical-- standards.

Drug Industry-- standards.

Laboratories-- standards.

Quality Control.

Chemical laboratories-- Standards.

Chemistry, Analytic-- Quality control.

Huber, Ludwig,1948-

20201204174226.0

[Book]

Y