{"product_id":"pharmaceutical-microbiological-quality-assurance-and-control-isbn-9781119356073","title":"Pharmaceutical Microbiological Quality Assurance and Control","description":"\u003cp\u003e\u003cb\u003eRelying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals.\u003c\/b\u003e\u003c\/p\u003e \u003cul\u003e \u003cli\u003eOffers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA\/QC\u003c\/li\u003e \u003cli\u003ePresents the latest developments in both regulatory expectations and technical advancements\u003c\/li\u003e \u003cli\u003eProvides guidance on statistical tools for risk assessment and trending of microbiological data\u003c\/li\u003e \u003cli\u003eDescribes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eEditors xix\u003c\/p\u003e \u003cp\u003eList of Contributors xxi\u003c\/p\u003e \u003cp\u003ePreface xxvii\u003c\/p\u003e \u003cp\u003eForeword xxxiii\u003c\/p\u003e \u003cp\u003eAcknowledgments xxxv\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Microbiological Control Strategy 1\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eDavid Roesti and Marcel Goverde\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 1\u003c\/p\u003e \u003cp\u003e1.2 Overview of a Microbial Control Strategy Program 2\u003c\/p\u003e \u003cp\u003e1.3 Main Factors to Be Controlled 4\u003c\/p\u003e \u003cp\u003e1.4 Conclusion 18\u003c\/p\u003e \u003cp\u003eBibliography 18\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Microbial Contamination Risk Assessment in Non‐sterile Drug Product Manufacturing and Risk Mitigation 23\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eTony Cundell\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 24\u003c\/p\u003e \u003cp\u003e2.2 Regulatory, Compendia, and Industry Guidance 24\u003c\/p\u003e \u003cp\u003e2.3 Putting into Perspective the Microbiological Risk Associated with Non‐sterile Products 25\u003c\/p\u003e \u003cp\u003e2.4 Risk Assessment Tools 29\u003c\/p\u003e \u003cp\u003e2.5 Organizational Risk Management Maturity 35\u003c\/p\u003e \u003cp\u003e2.6 Hierarchy of Risks 35\u003c\/p\u003e \u003cp\u003e2.7 Effect of Product Attributes 46\u003c\/p\u003e \u003cp\u003e2.8 Emerging Manufacturing Technologies 48\u003c\/p\u003e \u003cp\u003e2.9 A Case History 52\u003c\/p\u003e \u003cp\u003e2.10 Conclusions 53\u003c\/p\u003e \u003cp\u003eBibliography 53\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Qualification of Microbiological Laboratory Personnel and Equipment 57\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eRobert Schwarz\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 57\u003c\/p\u003e \u003cp\u003e3.2 Reasons, Requirements, and Strategies for Qualification 58\u003c\/p\u003e \u003cp\u003e3.3 Critical Aspects of Microbiological Methods 68\u003c\/p\u003e \u003cp\u003e3.4 Practical Examples for Qualification of Laboratory Personnel 72\u003c\/p\u003e \u003cp\u003eAcknowledgments 76\u003c\/p\u003e \u003cp\u003eBibliography 76\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Introduction to Culture Media in Pharmaceutical Microbiology for Non‐sterile Products 79\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eMarion Louis, Laurent Leblanc, and Félix A. Montero Julian\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 80\u003c\/p\u003e \u003cp\u003e4.2 Culture Media Challenges and Development 83\u003c\/p\u003e \u003cp\u003e4.3 Importance of Culture Media for Patient Safety 83\u003c\/p\u003e \u003cp\u003e4.4 Culture Media are all Different 83\u003c\/p\u003e \u003cp\u003e4.5 Innovation in Regard to Culture Media 91\u003c\/p\u003e \u003cp\u003e4.6 Quality Controls 92\u003c\/p\u003e \u003cp\u003e4.7 Culture Media Troubleshooting 98\u003c\/p\u003e \u003cp\u003e4.8 Conclusion 103\u003c\/p\u003e \u003cp\u003eBibliography 103\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Microbiological Examination of Non‐sterile Final Dosage Forms and Raw Material Including Acceptance Criteria and Testing Frequency 105\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eDavid Roesti\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5.1 Microbiological Acceptance Criteria 106\u003c\/p\u003e \u003cp\u003e5.2 Testing Frequency 112\u003c\/p\u003e \u003cp\u003e5.3 Procedure if Microbial Growth Occurs in Routine Testing 117\u003c\/p\u003e \u003cp\u003e5.4 Sampling 117\u003c\/p\u003e \u003cp\u003e5.5 Nutrient Medium Controls 120\u003c\/p\u003e \u003cp\u003e5.6 Test Method Overview 125\u003c\/p\u003e \u003cp\u003e5.7 Verification of the Suitability of the Method 127\u003c\/p\u003e \u003cp\u003e5.8 Microbiological Examination of Non‐sterile Products 142\u003c\/p\u003e \u003cp\u003e5.9 Elements to Consider for Raw Data Sheets 148\u003c\/p\u003e \u003cp\u003eAcknowledgments 149\u003c\/p\u003e \u003cp\u003eBibliography 149\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Microbial Requirements and Testing of Primary Packaging 153\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eMarcel Goverde\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 154\u003c\/p\u003e \u003cp\u003e6.2 Guidelines and Literature 161\u003c\/p\u003e \u003cp\u003e6.3 Acceptance Criteria and Testing Frequency 164\u003c\/p\u003e \u003cp\u003e6.4 Test Methods 170\u003c\/p\u003e \u003cp\u003e6.5 Suitability Test 174\u003c\/p\u003e \u003cp\u003e6.6 OOS Procedure 177\u003c\/p\u003e \u003cp\u003e6.7 Examples of OOS or OOE Cases 178\u003c\/p\u003e \u003cp\u003e6.8 Conclusion 184\u003c\/p\u003e \u003cp\u003eBibliography 185\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Utilities Design and Testing 189\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eTim Sandle\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 190\u003c\/p\u003e \u003cp\u003e7.2 Defining, Developing, and Maintaining Utilities 191\u003c\/p\u003e \u003cp\u003e7.3 Review of Critical Utilities 198\u003c\/p\u003e \u003cp\u003e7.4 Conclusion 226\u003c\/p\u003e \u003cp\u003eBibliography 227\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Microbiological Environmental Monitoring 231\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eAlexandra Stärk\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 232\u003c\/p\u003e \u003cp\u003e8.2 Microbiological Control Strategy 233\u003c\/p\u003e \u003cp\u003e8.3 Cleanliness Zoning Concept for Non‐sterile Products 233\u003c\/p\u003e \u003cp\u003e8.4 Microbiological Environmental Monitoring Strategy 234\u003c\/p\u003e \u003cp\u003e8.5 Microbiological Environmental Monitoring Methods 235\u003c\/p\u003e \u003cp\u003e8.6 Method Validations and Suitability Tests for Microbiological Environmental Monitoring 238\u003c\/p\u003e \u003cp\u003e8.7 Initial Validation of Cleanrooms and Production Equipment 244\u003c\/p\u003e \u003cp\u003e8.8 Definition of a Microbiological Environmental Routine Monitoring Program 246\u003c\/p\u003e \u003cp\u003e8.9 Microbiological Environmental Monitoring: Examples for Users 253\u003c\/p\u003e \u003cp\u003e8.10 Conclusion 261\u003c\/p\u003e \u003cp\u003eBibliography 262\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Identification of Microorganisms 265\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eChristine E. Farrance\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 266\u003c\/p\u003e \u003cp\u003e9.2 History and Challenges of Bacterial Taxonomy and Classification 268\u003c\/p\u003e \u003cp\u003e9.3 History and Challenges of Fungal Taxonomy and Classification 276\u003c\/p\u003e \u003cp\u003e9.4 Current Identification Technologies 279\u003c\/p\u003e \u003cp\u003e9.5 Strengths and Weaknesses with Each Categorical Method 306\u003c\/p\u003e \u003cp\u003e9.6 Case Studies from a Contract Testing Lab 309\u003c\/p\u003e \u003cp\u003e9.7 Conclusion 313\u003c\/p\u003e \u003cp\u003eBibliography 314\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Calculating Alert Levels and Trending of Microbiological Data 329\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eDavid Roesti\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 330\u003c\/p\u003e \u003cp\u003e10.2 Goal of the Chapter 332\u003c\/p\u003e \u003cp\u003e10.3 Alert Levels Based on Historical Data 332\u003c\/p\u003e \u003cp\u003e10.4 Trending 355\u003c\/p\u003e \u003cp\u003e10.5 Conclusion 367\u003c\/p\u003e \u003cp\u003eAcknowledgments 367\u003c\/p\u003e \u003cp\u003eBibliography 367\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Exclusion of Objectionable Microorganisms from Non‐sterile Pharmaceutical Drug Products 371\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eTony Cundell\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction 372\u003c\/p\u003e \u003cp\u003e11.2 What is an Objectionable Microorganism? 374\u003c\/p\u003e \u003cp\u003e11.3 Screening for Objectionable Microorganisms 383\u003c\/p\u003e \u003cp\u003e11.4 Risk‐Based Microbial Testing of Non‐sterile Drug Products 388\u003c\/p\u003e \u003cp\u003e11.5 Sources of Objectionable Microorganisms 389\u003c\/p\u003e \u003cp\u003e11.6 Risk Assessment to Determine if a Microorganism is Objectionable in a Non‐sterile Drug Product 392\u003c\/p\u003e \u003cp\u003e11.7 Case Histories 395\u003c\/p\u003e \u003cp\u003e11.8 Conclusions 398\u003c\/p\u003e \u003cp\u003eBibliography 399\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Data Integrity and Microbiological Excursion Handling 401\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eDavid Roesti and Marcel Goverde\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12.1 Data Integrity 401\u003c\/p\u003e \u003cp\u003e12.2 General Concept for Microbiological Excursion 410\u003c\/p\u003e \u003cp\u003e12.3 Considerations for Excursions 420\u003c\/p\u003e \u003cp\u003eBibliography 427\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Rapid Microbiological Methods 429\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eMichael J. Miller\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction 429\u003c\/p\u003e \u003cp\u003e13.2 The Current State of Microbiology Testing 431\u003c\/p\u003e \u003cp\u003e13.3 Rapid Microbiological Methods 432\u003c\/p\u003e \u003cp\u003e13.4 Applications for Non‐sterile Pharmaceutical Drug Products 433\u003c\/p\u003e \u003cp\u003e13.5 Technology Review 435\u003c\/p\u003e \u003cp\u003e13.6 Validating Rapid Microbiological Methods 447\u003c\/p\u003e \u003cp\u003e13.7 Developing a Business Case for Rapid Methods 454\u003c\/p\u003e \u003cp\u003e13.8 Summary 455\u003c\/p\u003e \u003cp\u003eBibliography 456\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Validation of a Rapid Microbiological Method for the Microbiological Examination of Non‐sterile and Nonfilterable Drug Products, APIs, and Excipients 459\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eOliver Gordon and David Roesti\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14.1 Introduction 460\u003c\/p\u003e \u003cp\u003e14.2 Method Validation 462\u003c\/p\u003e \u003cp\u003e14.3 Suitability Test (Product‐Specific Method Validation) 479\u003c\/p\u003e \u003cp\u003e14.4 Discussion 483\u003c\/p\u003e \u003cp\u003e14.5 Conclusion 486\u003c\/p\u003e \u003cp\u003eAcknowledgments 486\u003c\/p\u003e \u003cp\u003eBibliography 487\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 An Ex‐Regulator’s View of the Microbiology QA\/QC Functions in the US Pharmaceutical Industries 489\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eDavid Hussong\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15.1 Foods, Drugs, and Quality 489\u003c\/p\u003e \u003cp\u003e15.2 Why Microbes Confound a Census 492\u003c\/p\u003e \u003cp\u003e15.3 Microbiological QA Decisions 494\u003c\/p\u003e \u003cp\u003e15.4 Who Has Responsibility for Quality? 495\u003c\/p\u003e \u003cp\u003e15.5 Product and Process Planning 496\u003c\/p\u003e \u003cp\u003e15.6 Quality and Documentation in Drug Manufacturing 499\u003c\/p\u003e \u003cp\u003e15.7 Summary 500\u003c\/p\u003e \u003cp\u003eBibliography 501\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Practical Guide for Microbiological QA\/QC of Non‐sterile Pharmaceuticals Manufacturing for EU 505\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eIna Bach\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16.1 Introduction 505\u003c\/p\u003e \u003cp\u003e16.2 General Requirements 506\u003c\/p\u003e \u003cp\u003e16.3 Audit Assessment Tools of a Microbiological Laboratory 508\u003c\/p\u003e \u003cp\u003e16.4 Regulatory Audits in the Microbiology Department 514\u003c\/p\u003e \u003cp\u003e16.5 Conclusions 516\u003c\/p\u003e \u003cp\u003eBibliography 517\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Which Microbiological Tests Can Better Be Performed In‐house and What Can Be Easily Outsourced 519\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eThomas Meindl and Ingo Grimm\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17.1 Introduction 519\u003c\/p\u003e \u003cp\u003e17.2 Advantages and Disadvantages of Outsourcing 522\u003c\/p\u003e \u003cp\u003e17.3 Business Case and Hidden Costs 524\u003c\/p\u003e \u003cp\u003e17.4 Hidden Costs 528\u003c\/p\u003e \u003cp\u003e17.5 Quality Agreement Between the Contract Laboratory and the Requesting Company 529\u003c\/p\u003e \u003cp\u003e17.6 Auditing Contract Laboratories 532\u003c\/p\u003e \u003cp\u003e17.7 A Case History 532\u003c\/p\u003e \u003cp\u003e17.8 Conclusions 535\u003c\/p\u003e \u003cp\u003eBibliography 536\u003c\/p\u003e \u003cp\u003eIndex 539\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eDavid Roesti, PhD,\u003c\/b\u003e works at Novartis Pharma AG in Stein, Switzerland, and is responsible for defining the microbial control strategy at the site and is a global subject matter expert in microbiology for the Novartis group. He is also is an elected member of the General Chapters Microbiology Expert Committee of the Unites States Pharmacopoeia 2015–2020 revision cycle. \u003c\/p\u003e\u003cp\u003e\u003cb\u003eMarcel Goverde, PhD,\u003c\/b\u003e runs MGP Consulting GmbH for consulting, training and project management in GMP-relevant areas with a focus on microbiology, hygiene and deviation management. He is the Swiss expert in the EDQM group for Modern Microbiological Methods since 2003, which was then integrated into Group 1 (Microbiological Methods and Statistical Analysis) in 2015.   \u003c\/p\u003e\u003cp\u003e\u003cb\u003eA practical guide to microbiological quality and assurance for non-sterile drug manufacturing\u003c\/b\u003e  \u003c\/p\u003e\u003cp\u003e\u003ci\u003ePharmaceutical Microbiological Quality Assurance and Control\u003c\/i\u003e offers a thorough and practical guide for professionals working in the field of non-sterile drug manufacturing. Drawing on the authors' experience working in the field, the book contains a thorough and up-to-date approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Comprehensive in scope, the book covers state-of-the-art microbiology quality assurance and control (QA \/ QC) tests as well as risk mitigation strategies. \u003c\/p\u003e\u003cp\u003eThe book is designed so that professionals can implement the methodologies presented in a facility or laboratory to meet current microbiology manufacturing best practices. In addition, the authors (noted experts on the topic) discuss developments in microbiological testing technology. The authors have years of experience practicing microbiological QA\/QC in large multinational pharmaceutical companies and therefore present real-life complex cases involving tough decision-making. This important book: \u003c\/p\u003e\u003cul\u003e \u003cli\u003eOffers a comprehensive guide to non-sterile pharmaceuticals microbiological QA\/QC\u003c\/li\u003e \u003cli\u003eContains the most recent developments in both regulatory expectations and technical advancements\u003c\/li\u003e \u003cli\u003eProvides information on statistical tools for risk assessment and trending of microbiological data\u003c\/li\u003e \u003cli\u003eDescribes strategy and practical examples from the authors' experience\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003ci\u003ePharmaceutical Microbiological Quality Assurance and Control\u003c\/i\u003e is written for microbiologists and those in charge of microbiological quality, primarily working in pharmaceutical companies of every size and specialty in positions including those within: microbiology laboratories, QA\/QC departments, outsourcing departments, regulatory departments, and health regulatory authorities.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989772746981,"sku":"NP9781119356073","price":200.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119356073.jpg?v=1761785421","url":"https:\/\/k12savings.com\/es\/products\/pharmaceutical-microbiological-quality-assurance-and-control-isbn-9781119356073","provider":"K12savings","version":"1.0","type":"link"}