Validation and qualification in analytical laboratories
by
Huber, Ludwig, 1948-
Title
:
Validation and qualification in analytical laboratories
Author
:
Huber, Ludwig, 1948-
ISBN
:
9780849382673
Edition
:
2nd ed.
Publication Information
:
New York : Informa Healthcare, c2007.
Physical Description
:
v, 303 s. : res.
Contents
:
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 Term
:
Kimya, Farmasötik -- standartlar
Kimya, Analitik -- standartlar
Laboratuvarlar -- standartlar
Nitelik Denetimi
İlaç Endüstrisi -- standartlar
Chemistry, Pharmaceutical -- standards
Chemistry, Analytical -- standards
Laboratories -- standards
Quality Control
Drug Industry -- standards
Library | Material Type | Item Barcode | Shelf Number | [[missing key: search.ChildField.HOLDING]] | Status |
---|
Health Sciences Library | Book | 7.2/12/398179 | QV 744 H877 2007 | | Sağlık Bilimleri Genel Koleksiyon |