عنوان

Validation and qualification in analytical laboratories /

شابک

084938267X

شابک

9780849382673

شماره

b757536

عنوان اصلي

Validation and qualification in analytical laboratories /

نام عام مواد

[Book]

نام نخستين پديدآور

Ludwig Huber.

وضعيت ويراست

2nd ed.

محل نشرو پخش و غیره

New York :

نام ناشر، پخش کننده و غيره

Informa Healthcare,

تاریخ نشرو بخش و غیره

©2007.

نام خاص و کميت اثر

v, 303 pages :

ساير جزييات

illustrations ;

ابعاد

24 cm

متن يادداشت

Includes bibliographical references (pages 281-297) and index.

متن يادداشت

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.

بدون عنوان

0

متن يادداشت

"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.

موضوع مستند نشده

Chemical laboratories-- Standards.

موضوع مستند نشده

Chemistry, Analytic-- Quality control.

موضوع مستند نشده

Chemistry Techniques, Analytical-- standards.

موضوع مستند نشده

Chemistry, Pharmaceutical-- standards.

موضوع مستند نشده

Drug Industry-- standards.

موضوع مستند نشده

Laboratories-- standards.

موضوع مستند نشده

Quality Control.

موضوع مستند نشده

Chemical laboratories-- Standards.

موضوع مستند نشده

Chemistry, Analytic-- Quality control.

شماره

ويراست

شماره رده

نشانه اثر

شماره رده

شماره رده

نشانه اثر

مستند نام اشخاص تاييد نشده

Huber, Ludwig,1948-

تاريخ عمليات

20201204174226.0

نام الکترونيکي

نوع ماده

[Book]

تكميل شده

Y