LEADER 03041nam  22005774a 450 
001 9910143416803321
005 20220317125400.0
010   $a1-280-64898-8
010   $a9786610648986
010   $a0-470-04220-6
010   $a0-470-04219-2
035   $a(CKB)1000000000355002
035   $a(EBL)273997
035   $a(OCoLC)476017670
035   $a(SSID)ssj0000266480
035   $a(PQKBManifestationID)11206713
035   $a(PQKBTitleCode)TC0000266480
035   $a(PQKBWorkID)10304824
035   $a(PQKB)11757582
035   $a(MiAaPQ)EBC273997
035   $a(EXLCZ)991000000000355002
100   $a20051220d2006      uy             0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt
182   $cc
183   $acr
200 10$aValidating chromatographic methods$b[electronic resource] $ea practical guide /$fDavid M. Bliesner
210   $aHoboken, N.J. $cWiley$dc2006
215   $a1 online resource (301 p.)
300   $aDescription based upon print version of record.
311   $a0-471-74147-7 
320   $aIncludes bibliographical references (p. 283) and index.
327   $aVALIDATING CHROMATOGRAPHIC METHODS; CONTENTS; PREFACE; 1. OVERVIEW OF METHODS VALIDATION; 2. COMPONENTS OF METHODS VALIDATION; 3. STEP 1: METHOD EVALUATION AND FURTHER DEVELOPMENT; 4. STEP 2: FINAL METHOD DEVELOPMENT AND TRIAL METHODS VALIDATION; 5. STEP 3: FORMAL METHODS VALIDATION AND REPORT GENERATION; 6. STEP 4: FORMAL DATA REVIEW AND REPORT ISSUANCE; 7. SUMMARY; APPENDICES; I. GLOSSARY OF METHODS VALIDATION TERMS; II. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION STANDARD OPERATING PROCEDURE (SOP); III. TEMPLATE FOR AN EXAMPLE END-USER REQUIREMENTS QUESTIONNAIRE
327   $aIV. TEMPLATE FOR AN EXAMPLE METHOD REVIEW CHECKLISTV. TEMPLATE FOR AN EXAMPLE STANDARD TEST METHOD; VI. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION PROTOCOL; VII. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION REPORT; REFERENCES; INDEX
330   $aAll the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal
606   $aChromatographic analysis$xValidity
606   $aScience$xMethodology
608   $aElectronic books.
615  0$aChromatographic analysis$xValidity.
615  0$aScience$xMethodology.
676   $a543.8
676   $a543/.8
700   $aBliesner$b David M$0890967
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910143416803321
996   $aValidating chromatographic methods$92198546
997   $aUNINA