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PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality SHAYNE COX GAD, PH.D., D.A.B.T. Gad Consulting Services Cary, North Carolina A JOHN WILEY & SONS, INC., PUBLICATION PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality SHAYNE COX GAD, PH.D., D.A.B.T. Gad Consulting Services Cary, North Carolina A JOHN WILEY & SONS, INC., PUBLICATION Copyright © 2008 by John Wiley & Sons, Inc. 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For general information on our other products and services or for technical support, please contact our Customer Care Department within the United States at (800) 762-2974, outside the United States at (317) 572-3993 or fax (317) 572-4002. Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic formats. For more information about Wiley products, visit our web site at www.wiley.com. Library of Congress Cataloging-in-Publication Data is available. ISBN: 978-0-470-25959-7 Printed in the United States of America 10 9 8 7 6 5 4 3 2 1 CONTRIBUTORS v Emmanuel O. Akala, Department of Pharmaceutical Sciences, School of Pharmacy, Howard University, Washington, DC, Effect of Packaging on Stability of Drugs and Drug Products Giuseppe Alibrandi, Universit à di Messina, Messina, Italy, Alternative Accelerated Methods for Studying Drug Stability: Variable - Parameter Kinetics Edward R. Arling, Amgen, Inc., Thousand Oaks, California, Creating and Managing a Quality Management System Christina Bartmann, Medical University of Graz, Graz, Austria, GMP - Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells James M. Barquest, Ground Zero Pharmaceuticals, Inc., Irvine, California, Role of Quality Systems and Audits in Pharmaceutical Manufacturing Environment Denise Bohrer, Chemistry Department, Universidade Federal de Santa Maria, Santa Maria, Brazil, Origin of Contamination Chung Chow Chan, Azopharma Contract Pharmaceutical Services, Miramar, Florida, Analytical Method Validation: Principles and Practices Robert P. Cogdill, Duquense University Center for Pharmaceutical Technology, Pittsburgh, Pennsylvania, Case for Process Analytical Technology: Regulatory and Industrial Perspectives Marc De Loose, Institute for Agricultural and Fisheries Research (ILVO), Scientifi c Institute for the Flemish Community, Merelbeke, Belgium, Analytical Method Validation and Quality Assurance Katherine V. Domenick, Training and Communications Group, Inc., Berwyn, Pennsylvania, Personnel Training in Pharmaceutical Manufacturing vi CONTRIBUTORS Michelle E. Dowling, Amgen, Inc., Thousand Oaks, California, Creating and Man- aging a Quality Management System L. Antonio Est é vez, University of Puerto Rico, Mayag ü ez, Puerto Rico, Drug Stability D.C. Ferreira, Faculty of Pharmacy, University of Porto, Porto, Portugal, Pharma- ceutical Manufacturing Validation Principles Alvin Fox, University of South Carolina, Columbia, South Carolina, Quantita- tion of Markers for Gram - Negative and Gram - Positive Endotoxins in Work Environment and as Contaminants in Pharmaceutical Products Using Gas Chromatography – Tandem Mass Spectrometry Paul A. Frankel, Amgen, Inc., Thousand Oaks, California, Creating and Managing a Quality Management System David A. Gallup, Training and Communications Group, Inc., Berwyn, Pennsylvania, Personnel Training in Pharmaceutical Manufacturing Srinivas Ganta, University of Auckland, Auckland, New Zealand, Scale - Up and Postapproval Changes (SUPAC) Regulations Sanjay Garg, University of Auckland, Auckland, New Zealand, Scale - Up and Post- approval Changes (SUPAC) Regulations Marge Gillis, Training and Communications Group, Inc., Berwyn, Pennsylvania, Personnel Training in Pharmaceutical Manufacturing James R. Harris, James Harris Associates, Inc., Durham, North Carolina, Good Manufacturing Practices (GMP) and Related FDA Guidelines Ashley John, New Jersey Institute of Technology, Newark, New Jersey, Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems Herman Lam, Wild Crane Horizon, Inc., Scarborough, Ontario, Canada, Validation of Laboratory Instruments Marko N ä rhi, Helsinki University of Technology, Helsinki, Finland, National GMP Regulations and Codes and International GMP Guides and Guidelines: Corre- spondences and Differences Kenneth J. Nolan, Nolan & Auerbach, Fort Lauderdale, Florida, Enforcement of Good Manufacturing Practices Katrina Nordstr ö m, Helsinki University of Technology, Helsinki, Finland, National GMP Regulations and Codes and International GMP Guides and Guidelines: Correspondences and Differences Nazario D. Ramirez - Beltran, University of Puerto Rico, Mayag ü ez, Puerto Rico, Drug Stability Gregory N. Ranky, Public Research University of New Jersey, Newark, New Jersey, Analytical and Computational Methods and Examples for Designing and Control- ling Total Quality Management Pharmaceutical Manufacturing Systems CONTRIBUTORS vii Paul G. Ranky, New Jersey Institute of Technology, Newark, New Jersey, Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems Richard G. Ranky, New Jersey Institute of Technology, Newark, New Jersey, Ana- lytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems Andreas Reinisch, Medical University of Graz, Graz, Austria, GMP - Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells Harry Rodriguez, Cordis LLC, a Johnson & Johnson Company, San Juan, Puerto Rico, Drug Stability Yves Roggo, F. Hoffmann - La Roche, Ltd., Basel, Switzerland, Process Analytical Technology; Chemical Imaging and Chemometrics: Useful Tools for Process Ana- lytical Technology Eva Rohde, Medical University of Graz, Graz, Austria, GMP - Compliant Propaga- tion of Human Multipotent Mesenchymal Stromal Cells B. Saramento, Faculty of Pharmacy, University of Porto, Porto, Portugal, Pharma- ceutical Manufacturing Validation Principles Katharina Schallmoser, Medical University of Graz, Graz, Austria, GMP - Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells Puneet Sharma, University of Auckland, Auckland, New Zealand, Scale - Up and Postapproval Changes (SUPAC) Regulations Evan B. Siegel, Ground Zero Pharmaceuticals, Inc., Irvine, California, Role of Quality Systems and Audits in Pharmaceutical Manufacturing Environment E.B. Souto, Free University of Berlin, Berlin, Germany; Faculty of Pharmacy, University of Porto, Porto, Portugal, Pharmaceutical Manufacturing Validation Principles Dirk Strunk, Medical University of Graz, Graz, Austria, GMP - Compliant Propaga- tion of Human Multipotent Mesenchymal Stromal Cells Michel Ulmschneider, F. Hoffman - La Roche, Ltd., Basel, Switzerland, Process Ana- lytical Technology; Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology Isabel Taverniers, Institute for Agricultural and Fisheries Research (ILVO), Scien- tifi c Institute for the Flemish Community, Merelbeke, Belgium, Analytical Method Validation and Quality Assurance Erik Van Bockstaele, Institute for Agricultural and Fisheries Research (ILVO), Scientifi c Institute for the Flemish Community, Merelbeke, Belgium, Analytical Method Validation and Quality Assurance T. Vasconcelos, Laboratory of Pharmaceutical Development, BIAL, Mamede do Coronado, Portugal; Faculty of Pharmacy, University of Porto, Porto, Portugal, Pharmaceutical Manufacturing Validation Principles viii CONTRIBUTORS Ranga Velagaleti, BASF Corporation, Florham Park, New Jersey, Microbiology of Nonsterile Pharmaceutical Manufacturing; Stability and Shelf Life of Pharmaceu- tical Products Andrew A. Webster, McWhorter School of Pharmacy, Birmingham, Alabama, Phar- maceutical Product Stability Jyh - hone Wang, University of Rhode Island, Kingston, Rhode Island, Quality Process Improvement [...]... Bartmann, Andreas Reinisch, and Dirk Strunk SECTION 2 2.1 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences 117 119 Marko Närhi and Katrina Nordström ix x CONTENTS SECTION 3 3.1 QUALITY Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management... Changes (SUPAC)—Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation Other GMP-Related Guidance Documents Pharmaceutical Manufacturing Handbook: Regulations and Quality, edited by Shayne Cox Gad Copyright © 2008 John Wiley & Sons, Inc 3 4 1.1.1 GOOD MANUFACTURING PRACTICES & RELATED FDA GUIDELINES FDA REGULATIONS: REAL AND IMAGINED A regulation... Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations 1.1.3.1 CGMPS and the Concepts of Modern Quality Systems 1.1.3.2 Quality Systems Model Guidance for Industry: PAT—Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance 1.1.4.1 PAT Framework Guidance for Industry: Part 11 Electronic Records; Electronic Signatures—Scope and. .. understand how to formulate and deliver the drug) to identification of sources of contamination and assessment of stability The Handbook of Manufacturing: Regulations and Quality seeks to cover the entire range of available approaches to satisfying the wide range of regulatory requirements for making a highly defined product that constitutes a successful new drug and how to do so in as effective and as... Controlling Total Quality Management Pharmaceutical Manufacturing Systems 163 165 Paul G Ranky, Gregory N Ranky, Richard G Ranky, and Ashley John 3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment 201 Evan B Siegel and James M Barquest 3.3 Creating and Managing a Quality Management System 239 Edward R Arling, Michelle E Dowling, and Paul A Frankel 3.4 Quality Process Improvement... 839 PREFACE This Handbook of Manufacturing: Regulations and Quality focuses on all regulatory aspects and requirements that govern how drugs are produced for evaluation (and, later, sale to and use in) humans The coverage ranges from what the issues are at the early stages (when the amounts are small and the materials of limited sophistication) up to until the issue is reproducibly and continuously... (c) Containers and closures should be clean and, if necessary, sterile and processed to remove pyrogens (d) Standards or specification, methods of testing, and, if appropriate, sterilization and depyrogenation must be written and followed Production and Process Controls 1 Written procedures and procedure deviations (a) Written procedures for production and process control must be written and followed... deliverable and stable new drug xiii SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES 1.1 GOOD MANUFACTURING PRACTICES (GMP) AND RELATED FDA GUIDELINES James R Harris James Harris Associates, Inc., Durham, North Carolina Contents 1.1.1 1.1.2 1.1.3 1.1.4 1.1.5 1.1.6 1.1.7 1.1.8 1.1.9 FDA Regulations: Real and Imagined 21 CFR 210 and 211: Current Good Manufacturing Practice for Finished Pharmaceuticals... conform to the established standards must be written and followed (b) Reprocessing must not be performed without the review and approval of the quality control unit Packaging and Labeling Control 1 Materials examination and usage criteria (a) Written procedures describing in detail the receipt, identification, storage, handling, sampling, examination, and/ or testing of labeling and packaging materials must... Giuseppe Alibrandi SECTION 8 VALIDATION 725 8.1 727 Analytical Method Validation: Principles and Practices Chung Chow Chan 8.2 Analytical Method Validation and Quality Assurance 743 Isabel Taverniers, Erik Van Bockstaele, and Marc De Loose 8.3 Validation of Laboratory Instruments 791 Herman Lam 8.4 Pharmaceutical Manufacturing Validation Principles 811 E B Souto T Vasconcelos D C Ferreira, and B Sarmento . & SONS, INC., PUBLICATION PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality SHAYNE COX GAD, PH.D., D.A.B.T. Gad. successfully a deliverable and stable new drug. GOOD MANUFACTURING PRACTICES ( GMP ) AND OTHER FDA GUIDELINES SECTION 1 3 1.1 Pharmaceutical Manufacturing Handbook: Regulations and Quality, edited. to understand how to formulate and deliver the drug) to identifi cation of sources of contamination and assessment of stability. The Handbook of Manufacturing: Regulations and Quality seeks