03003nam 22005654a 450 991084058750332120230124182228.01-280-64898-897866106489860-470-04220-60-470-04219-2(CKB)1000000000355002(EBL)273997(OCoLC)476017670(SSID)ssj0000266480(PQKBManifestationID)11206713(PQKBTitleCode)TC0000266480(PQKBWorkID)10304824(PQKB)11757582(MiAaPQ)EBC273997(EXLCZ)99100000000035500220051220d2006 uy 0engur|n|---|||||txtccrValidating chromatographic methods[electronic resource] a practical guide /David M. BliesnerHoboken, N.J. Wileyc20061 online resource (301 p.)Description based upon print version of record.0-471-74147-7 Includes bibliographical references (p. 283) and index.VALIDATING 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 QUESTIONNAIREIV. 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; INDEXAll 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 minimalChromatographic analysisValidityScienceMethodologyChromatographic analysisValidity.ScienceMethodology.543.8543/.8Bliesner David M890967MiAaPQMiAaPQMiAaPQBOOK9910840587503321Validating chromatographic methods4134516UNINA