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Validation and qualification in analytical laboratories / Ludwig Huber.

By: Material type: TextTextPublication details: London : Informa Healthcare, 2007.Edition: 2nd edDescription: 214 p. ; 23 cmISBN:
  • 9780849382673 (hbk.) :
  • 9780849382673 (Cloth)
Subject(s): DDC classification:
  • 543.0685 HUB
LOC classification:
  • QD75.4.Q34 H83 2007
Contents:
1.Introduction -- 2.Regulations, standards and guidelines -- 3.Terminology and validation overview -- 4.Risk-based validation and qualification -- 5.Master and project planning for equipment and computer systems -- 6.Design qualification -- 7.Installation qualification -- 8.Operational qualification -- 9.Peformance qualification and maintenance -- 10.Special considerations for software and computer systems -- 11.Validatio of analytical methods -- 12.Data review and validation and evaluations of uncertainty -- 13.Handling-out-of-specification situations -- 14.(Certified) reference standards -- 15.People -- 16.Proficiency testing for external laboratory qualificatioin -- 17.Audits.
Summary: This second edition explains how to improve pharmaceutical product quality while achieving compliance with global regulatory standards.
Holdings
Item type Current library Call number Copy number Status Date due Barcode
Long Loan TUS: Midlands, Main Library Athlone General Lending 543.0685 HUB (Browse shelf(Opens below)) 1 Available 00214472
Long Loan TUS: Midlands, Main Library Athlone General Lending 543.0685 HUB (Browse shelf(Opens below)) 1 Available 00214473

Previous ed.: Buffalo Grove, Ill.: Interpharm, 1999:.

Includes bibliographical references and index.

1.Introduction -- 2.Regulations, standards and guidelines -- 3.Terminology and validation overview -- 4.Risk-based validation and qualification -- 5.Master and project planning for equipment and computer systems -- 6.Design qualification -- 7.Installation qualification -- 8.Operational qualification -- 9.Peformance qualification and maintenance -- 10.Special considerations for software and computer systems -- 11.Validatio of analytical methods -- 12.Data review and validation and evaluations of uncertainty -- 13.Handling-out-of-specification situations -- 14.(Certified) reference standards -- 15.People -- 16.Proficiency testing for external laboratory qualificatioin -- 17.Audits.

This second edition explains how to improve pharmaceutical product quality while achieving compliance with global regulatory standards.

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