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Method Validation in Pharmaceutical Analysis

Method Validationin Pharmaceutical AnalysisEdited byJ. Ermer and J. H. McB. MillerMethod Validation in Pharmaceutical Analysis . A Guide to Best Practice. Joachim Ermer, John H. McB. Miller (Eds.)Copyright 2005 WILEY-VCH Verlag GmbH & Co. KGaA, WeinheimISBN: 3-527-31255-2 Related Titles from Wiley-VCH:M. S. LeeLC/MS Applications in Drug Development2002 ISBN: 0-471-40520-5M. Stoeppler, W. R. Wolf, P. J. Jenks (Eds.)Reference Materials for Chemical AnalysisCertification, Availability, and Proper Usage2001 ISBN: 3-527-30162-3J. M. Miller, J. B. Crowther (Eds.)Analytical Chemistry in a GMP EnvironmentA Practical Guide2000 ISBN: 0-471-31431-5 Method Validation in Pharmaceutical AnalysisA Guide to Best PracticeEdited byJoachim Ermer, John H. McB. MillerEdited byDr. Joachim Ermersanofi-aventisIndustriepark H chstBuild. G87565926 FrankfurtGermanyDr. John H. McB. MillerEuropean Directorate for the Qualityof Medicines (EDQM)16, Rue Auguste Himly67000 StrasbourgFrance&This book was carefully produced.

2.3 Accuracy 63 Joachim Ermer 2.3.1 Drug Substance 64 2.3.2 Drug Product 67 2.3.3 Impurities/Degradants and Water 71 2.3.4 Cleaning Validation Methods 74 2.3.5 Acceptance Criteria 77 2.3.6 Key Points 79 2.4 Linearity 80 Joachim Ermer

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Transcription of Method Validation in Pharmaceutical Analysis

1 Method Validationin Pharmaceutical AnalysisEdited byJ. Ermer and J. H. McB. MillerMethod Validation in Pharmaceutical Analysis . A Guide to Best Practice. Joachim Ermer, John H. McB. Miller (Eds.)Copyright 2005 WILEY-VCH Verlag GmbH & Co. KGaA, WeinheimISBN: 3-527-31255-2 Related Titles from Wiley-VCH:M. S. LeeLC/MS Applications in Drug Development2002 ISBN: 0-471-40520-5M. Stoeppler, W. R. Wolf, P. J. Jenks (Eds.)Reference Materials for Chemical AnalysisCertification, Availability, and Proper Usage2001 ISBN: 3-527-30162-3J. M. Miller, J. B. Crowther (Eds.)Analytical Chemistry in a GMP EnvironmentA Practical Guide2000 ISBN: 0-471-31431-5 Method Validation in Pharmaceutical AnalysisA Guide to Best PracticeEdited byJoachim Ermer, John H. McB. MillerEdited byDr. Joachim Ermersanofi-aventisIndustriepark H chstBuild. G87565926 FrankfurtGermanyDr. John H. McB. MillerEuropean Directorate for the Qualityof Medicines (EDQM)16, Rue Auguste Himly67000 StrasbourgFrance&This book was carefully produced.

2 Nevertheless,editors, authors, and publisher do not warrant theinformation contained therein to be free of are advised to keep in mind that statements,data, illustrations, procedural details or other itemsmay inadvertently be of Congress Card forBritish Library Cataloguing-in-Publication DataA catalogue record for this book is available from theBritish information publishedby Die Deutsche BibliothekDie Deutsche Bibliothek lists this publicationin the Deutsche Nationalbibliografie; detailedbibliographic data is available in the Internet at< >. 2005 WILEY-VCH Verlag GmbH & Co. KGaA,WeinheimAll rights reserved (including those of translationinto other languages). No part of this book may bereproduced in any form by photoprinting, micro-film, or any other means nor transmitted or trans-lated into machine language without written permis-sion from the publishers. Registered names, trade-marks, etc. used in this book, even when notspecifically marked as such, are not to be consideredunprotected by in the Federal Republic of on acid-free hn & Weyh, Satz und Medien,FreiburgPrintingbetz-druck GmbH, DarmstadtBookbindingLitges & Dopf Buchbinderei GmbH,HeppenheimISBN-13:978-3-527-31255-9 ISBN-10:3-527-31255-2A number of articles and guidelines already exist dealing with the Validation of ana-lytical methods .

3 However, the editors consider that none of the texts completely cov-ers all aspects pertinent to analytical Validation for, in particular, methods in phar-maceutical Analysis . The editors have attempted, with the authors of the relevantchapters, to bring all these elements together in one book that will be useful to bothanalysts in the Pharmaceutical industry (and beyond) as well as to assessors at theregistration authorities for used in Pharmaceutical Analysis must be sufficiently accurate, specific,sensitive and precise to conform to the regulatory requirements as set out in therelevant guidelines of "The International Conference of Technical Requirements forthe Registration of Pharmaceutical for Human Use " (ICH), which are applied bythe licensing authorities and by some pharmacopoeias. The chapters in Part I dealspecifically with the fundamentals of the different Validation parameters, giving spe-cial emphasis to practical examples and recommendations.

4 It is not intended toreplace statistical textbooks but the editors have attempted to provide sufficient back-ground information, illustrated by practical examples to aid the reader in under-standing and choosing the relevant parameters and acceptance criteria to be consid-ered for the application of any one analytical procedure to a particular to Part II of this book deal with the life-cycle approach to validationstarting with the qualification of equipment employed, the adaptation of ICH guide-lines to the early stages of drug development, the relation between analytical vari-ability and specification acceptance criteria, the continual assessment of the perfor-mance of the methods when in regular use, the transfer of analytical procedures,and out-of-specification results. There are also chapters dealing with the validationof pharmacopoeial methods and future perspectives for 2004 John H. McB. MillerJoachim ErmerVPrefaceMethod Validation in Pharmaceutical Analysis .

5 A Guide to Best Practice. Joachim Ermer, John H. McB. Miller (Eds.)Copyright 2005 WILEY-VCH Verlag GmbH & Co. KGaA, WeinheimISBN: 3-527-31255-2 PrefaceVList of ContributorsXIIIPart I Fundamentals of Validation in Pharmaceutical Analysis11 Analytical Validation within the Pharmaceutical Environment3 Joachim and Continuous Planning and Design of Validation Look on the Routine Side of and Acceptance does Suitability Mean? Points142 Performance Parameters, Calculations and Describing the Distribution of Analytical Ranges for to Obtain and Supplement of Specificity by Purity (Co-elution) Points62 VIIC ontentsMethod Validation in Pharmaceutical Analysis . A Guide to Best Practice. Joachim Ermer, John H. McB. Miller (Eds.)Copyright 2005 WILEY-VCH Verlag GmbH & Co. KGaA, WeinheimISBN: and Validation Linear Linear and Other Regression and Quantitation Limit101 Joachim Ermer and Christopher Detector for DL/QL in Pharmaceutical Impurity Based on the of DL/QL from of the Various and of Robustness of Computer-assisted Robustness Suitability Tests170 John H.

6 McB. Techniques1713 Case Study: Validation of an HPLC- Method for Identity,Assay, and Related Impurities195 Gerd and Quantitation Limit and Quantitation Limit and Quantitation Limit of Part I213 Part II Life-cycle Approach to Analytical Validation2274 Qualification of Analytical Equipment229 David Overview of the Equipment Qualification of the EQ of Equipment Qualification (DQ) Qualification (IQ) Qualification (OQ) Qualification (PQ) and and During Drug Product Development Considerationsas a Function of the Stage of Drug Development243 Martin During Early Drug During Early 1: Assay or Content Uniformity of a Drug Product byHPLC During Early Drug Product Development: Proposal for aValidation of Example 1: More than on Strength of Drug 2: Degradation Products from a Drug Product by HPLC DuringEarly Drug Product Development: Proposal for a Validation 3: Residual Solvents of a Drug Product by GC During Early DrugProduct Development: Proposal for a Validation 4: Analytical Method Verification for GLP 5: Dissolution Rate of a Drug Product During Early DrugProduct Development: Proposal for Validation of other Tests (Early Development) Criteria and Analytical Variability265 Hermann of the the Analytical of Drug of Active Ingredients in Drug of Analytical Procedures281 Mark Broughton and Joachim Ermer (Section ) Review of the Analytical Laboratory Design and Acceptance of Pharmacopoeial Methods301 John H.

7 McB. of or Optical test for Absorption Techniques (Organic Impurities) on of Solvents or Organic Volatile Procedures in a Quality Control Environment337 Raymond A. the Performance of the Analytical of Suitability Test Parameters and Acceptance of Check or Control Stability and Limits and of Control of Control in Control of Control Elements of Test Procedure Change Control for Calibration and Preventative Calibration and Preventative is an Adjustment Really a Change? Adjustments versus Process Control (SPC) of Control of Statistical Process or Atypical Results355 Christopher Failure Concepts of Measurement , Results and Reportable of Variability in Analytical methods and Process of Atypical or Aberrant Outlier Tests for Out-of-Expectation Analysis for Quality Analysis of System Suitability Trends in Analytical Method Validation387 David Real Time Analytical Consequences of Real Time Analytical Validation Calibrate or not to Calibrate?

8 Of Analytically-based Control is the Basis for the Decision-Making Process? are the Acceptable Operating Ranges? of Process Martin BlochAnalytical Research and BaselSwitzerlandMark BroughtonHead of QC AnalyticsHolmes ChapelAventisLondon Road, Holmes Chapel Crewe,Cheshire CW4 8 BEUKDr. Christopher BurgessBurgess Consultancy Rose Rae , The Lendings, Startforth,Barnard Castle, Co,Durham DL12 9 ABUnited KingdomMr. Ray CoxRetired from:Abbott LaboratoriesManager Corporate Compendia andReference Standards1222 Pigeon Creek RdGreeneville, TN 37743 USADr. Joachim ErmerDirector of Analytical Processes andTechnologyGlobal Analytical Development,QO TSS AventisIndustriepark H chstBuild. G87565926 Frankfurt am MainGermanyDr. Gerd KleinschmidtHead of Laboratory (New Projects andTechnologies) Global PharmaceuticalDevelopment Analytical Sciences,GDPAnSc AventisIndustriepark H chstBuild. H79065926 Frankfurt am MainGermanyDr. John H.

9 McB. MillerHead of the Division III (Laboratory)European Directorate for the Quality ofMedicines (EDQM)16, rue Auguste Himly67000 StrasbourgFranceDr. David RuddGlaxo SmithklineBuilding 5 Park Road,Ware Hertfordshire SG12 0 DPUnited KingdomXIIIList of ContributorsMethod Validation in Pharmaceutical Analysis . A Guide to Best Practice. Joachim Ermer, John H. McB. Miller (Eds.)Copyright 2005 WILEY-VCH Verlag GmbH & Co. KGaA, WeinheimISBN: 3-527-31255-2 Prof. Hermann W tzigTechnical University BraunschweigInstitut f r Pharmazeutische ChemieBeethovenstr. 5538106 BraunschweigGermanyList of ContributorsXIV1 Part I:Fundamentals of Validation in Pharmaceutical AnalysisMethod Validation in Pharmaceutical Analysis . A Guide to Best Practice. Joachim Ermer, John H. McB. Miller (Eds.)Copyright 2005 WILEY-VCH Verlag GmbH & Co. KGaA, WeinheimISBN: 3-527-31255-23 Validation is, of course, a basic requirement to ensure quality and reliability of theresults for all analytical applications [8].

10 However, in comparison with analyticalchemistry, in Pharmaceutical Analysis , some special aspects and conditions existthat need to be taken into consideration. For example, the analytical procedures(apart from pharmacopoeial monographs) are often in-house developments andapplications. Therefore, the degree of knowledge and expertise is initially much larg-er compared with standard methods . The same can be assumed for the samplesanalysed. The matrix (placebo) in Pharmaceutical Analysis is usually constant andwell known and the ranges where the sample under Analysis can be expected areusually well defined and not very large. Evaluation (of batches, stability investiga-tions, etc.) is based on the results of various procedures or control tests, thus theirperformances can complement each other. Acceptance limits of the specification arefixed values, often based on tradition, as in the case of assay of an active ingredient,or they may be based on specific toxicological studies, which take large safety factorsinto account, as for impurities.


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