Huber, Ludwig,  1948- <br/><br/>
Validation and qualification in analytical laboratories / 
Ludwig Huber. 
 - 2nd ed. 
 - London :  Informa Healthcare,  2007. 
 - 214 p. ;  23 cm. 
<br/><br/> Previous ed.: Buffalo Grove, Ill.: Interpharm, 1999:. 
<br/><br/>Includes bibliographical references and index. 
<br/><br/>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. 
<br/><br/> This second edition explains how to improve pharmaceutical product quality while achieving compliance with global regulatory standards. 
<br/><br/><label>ISBN: </label>9780849382673 (hbk.) :  £130.00 9780849382673 (Cloth) 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Chemistry, Analytic--Quality control<br/>Chemical laboratories--Standards<br/>Science.<br/>Medicine: general issues<br/>Pharmaceutical chemistry & technology<br/>Pharmacology
<br/><br/><label>LC Class. No.: </label>QD75.4.Q34  / H83 2007 
<br/><br/><label>Dewey Class. No.: </label>543.0685 HUB