{"product_id":"pharmaceutical-microbiological-quality-assurance-and-control-9781119356073","title":"Pharmaceutical Microbiological Quality Assurance","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\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\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\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","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49407036817751,"sku":"9781119356073","price":139.45,"currency_code":"GBP","in_stock":false}],"url":"https:\/\/bookcurl.com\/products\/pharmaceutical-microbiological-quality-assurance-and-control-9781119356073","provider":"Book Curl","version":"1.0","type":"link"}