Validation and qualification in analytical laboratories / Ludwig Huber.
Material type: TextPublication details: London : Informa Healthcare, 2007.Edition: 2nd edDescription: 214 p. ; 23 cmISBN:- 9780849382673 (hbk.) :
- 9780849382673 (Cloth)
- 543.0685 HUB
- QD75.4.Q34 H83 2007
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.