Cargando…

Practical Approaches to Method Validation and Essential Instrument Qualification.

Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirementsComplementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additiona...

Descripción completa

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Chan, Chung Chow
Otros Autores: Lam, Herman, Zhang, Xue-Ming
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken : John Wiley & Sons, 2011.
Temas:
Acceso en línea:Texto completo

MARC

LEADER 00000cam a2200000Mu 4500
001 EBOOKCENTRAL_ocn730151616
003 OCoLC
005 20240329122006.0
006 m o d
007 cr |n|---|||||
008 110613s2011 xx o 000 0 eng d
040 |a EBLCP  |b eng  |e pn  |c EBLCP  |d OCLCQ  |d AU@  |d OCLCO  |d RECBK  |d OCLCF  |d DEBSZ  |d OCLCO  |d OCLCQ  |d OCLCO  |d ZCU  |d MERUC  |d OCLCQ  |d ICG  |d OCLCQ  |d DKC  |d OCLCQ  |d OCLCO  |d OCLCQ  |d OCLCO  |d OCLCL 
019 |a 781473594  |a 864904804 
020 |a 9781118060315 
020 |a 1118060318 
020 |a 9780470630716 
020 |a 047063071X 
020 |a 9780470630709 
020 |a 0470630701 
028 0 1 |a EB00062428  |b Recorded Books 
029 1 |a AU@  |b 000048843271 
029 1 |a DEBBG  |b BV044151731 
029 1 |a DEBSZ  |b 430964676 
029 1 |a DEBSZ  |b 449229696 
035 |a (OCoLC)730151616  |z (OCoLC)781473594  |z (OCoLC)864904804 
050 4 |a RS189.P66 2010 
082 0 4 |a 543.19  |a 615/.1901 
049 |a UAMI 
100 1 |a Chan, Chung Chow. 
245 1 0 |a Practical Approaches to Method Validation and Essential Instrument Qualification. 
260 |a Hoboken :  |b John Wiley & Sons,  |c 2011. 
300 |a 1 online resource (722 pages) 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
505 0 |a Cover; Title Page; Copyright Page; Preface; Contributors; Chapter 1: Overview of Risk-Based Approach to Phase Appropriate Validation and Instrument Qualification; Chapter 2: Phase Appropriate Method Validation; Chapter 3: Analytical Method Verification, Method Revalidation, and Method Transfer; Chapter 4: Validation of Process Analytical Technology Applications; Chapter 5: Validation of Near-Infrared Systems for Raw Material Identification; Chapter 6: Cleaning Validation; Chapter 7: Risk-Based Validation of Laboratory Information Management Systems. 
505 8 |a Chapter 8: Performance Qualification and Verification of BalanceChapter 9: Performance Verification of NIR Spectrophotometers; Chapter 10: OPERATIONAL QUALIFICATION IN PRACTICE FOR GAS CHROMATOGRAPHY INSTRUMENTS; Chapter 11: Performance Verification on Refractive Index, Fluorescence, and Evaporative Light-Scattering Detection; Chapter 12: Instrument qualification and performance verification for particle size instruments; Chapter 13: Method Validation, Qualification, and Performance Verification for Total Organic Carbon Analyzers; Chapter 14: Instrument Performance Verification: MicroPipettes. 
505 8 |a Chapter 15: Instrument Qualification and Performance Verification for Automated Liquid-Handling SystemsChapter 16: Performance Qualification and Verification in Powder X-Ray Diffraction; Index. 
520 |a Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirementsComplementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument. 
588 0 |a Print version record. 
590 |a ProQuest Ebook Central  |b Ebook Central Academic Complete 
650 0 |a Drugs  |x Analysis  |x Methodology  |x Evaluation. 
650 0 |a Laboratories  |x Equipment and supplies  |x Evaluation. 
650 0 |a Laboratories  |x Instruments  |x Evaluation. 
650 6 |a Médicaments  |x Analyse  |x Méthodologie  |x Évaluation. 
650 6 |a Laboratoires  |x Instruments  |x Évaluation. 
650 7 |a SCIENCE  |x Chemistry  |x Analytic.  |2 bisacsh 
650 7 |a Science  |2 fast 
700 1 |a Lam, Herman. 
700 1 |a Zhang, Xue-Ming. 
758 |i has work:  |a Practical Approaches to Method Validation and Essential Instrument Qualification [electronic resource] (Text)  |1 https://id.oclc.org/worldcat/entity/E39PD3P7HFtBjhhQt6gFGGkHcq  |4 https://id.oclc.org/worldcat/ontology/hasWork 
776 0 8 |i Print version:  |a Chan, Chung Chow.  |t Practical Approaches to Method Validation and Essential Instrument Qualification.  |d Hoboken : John Wiley & Sons, Inc., ©2011  |z 9780470121948 
856 4 0 |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=675009  |z Texto completo 
938 |a ProQuest Ebook Central  |b EBLB  |n EBL675009 
938 |a Recorded Books, LLC  |b RECE  |n rbeEB00062428 
994 |a 92  |b IZTAP