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Relying 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. * Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC * Presents the latest developments in both regulatory expectations and technical advancements * Provides guidance on statistical tools for risk assessment and trending of microbiological data * Describes strategy and practical examples from the authors' experience in globalized pharmaceutical companies and expert networks…mehr
Relying 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. * Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC * Presents the latest developments in both regulatory expectations and technical advancements * Provides guidance on statistical tools for risk assessment and trending of microbiological data * Describes strategy and practical examples from the authors' experience in globalized pharmaceutical companies and expert networks
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David Roesti, PhD, 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. Marcel Goverde, PhD, 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.
Inhaltsangabe
Editors xix
List of Contributors xxi
Preface xxvii
Foreword xxxiii
Acknowledgments xxxv
1 Microbiological Control Strategy 1 David Roesti and Marcel Goverde
1.1 Introduction 1
1.2 Overview of a Microbial Control Strategy Program 2
1.3 Main Factors to Be Controlled 4
1.4 Conclusion 18
Bibliography 18
2 Microbial Contamination Risk Assessment in Non-sterile Drug Product Manufacturing and Risk Mitigation 23 Tony Cundell
2.1 Introduction 24
2.2 Regulatory, Compendia, and Industry Guidance 24
2.3 Putting into Perspective the Microbiological Risk Associated with Non-sterile Products 25
2.4 Risk Assessment Tools 29
2.5 Organizational Risk Management Maturity 35
2.6 Hierarchy of Risks 35
2.7 Effect of Product Attributes 46
2.8 Emerging Manufacturing Technologies 48
2.9 A Case History 52
2.10 Conclusions 53
Bibliography 53
3 Qualification of Microbiological Laboratory Personnel and Equipment 57 Robert Schwarz
3.1 Introduction 57
3.2 Reasons, Requirements, and Strategies for Qualification 58
3.3 Critical Aspects of Microbiological Methods 68
3.4 Practical Examples for Qualification of Laboratory Personnel 72
Acknowledgments 76
Bibliography 76
4 Introduction to Culture Media in Pharmaceutical Microbiology for Non-sterile Products 79 Marion Louis, Laurent Leblanc, and Félix A. Montero Julian
4.1 Introduction 80
4.2 Culture Media Challenges and Development 83
4.3 Importance of Culture Media for Patient Safety 83
4.4 Culture Media are all Different 83
4.5 Innovation in Regard to Culture Media 91
4.6 Quality Controls 92
4.7 Culture Media Troubleshooting 98
4.8 Conclusion 103
Bibliography 103
5 Microbiological Examination of Non-sterile Final Dosage Forms and Raw Material Including Acceptance Criteria and Testing Frequency 105 David Roesti
5.1 Microbiological Acceptance Criteria 106
5.2 Testing Frequency 112
5.3 Procedure if Microbial Growth Occurs in Routine Testing 117
5.4 Sampling 117
5.5 Nutrient Medium Controls 120
5.6 Test Method Overview 125
5.7 Verification of the Suitability of the Method 127
5.8 Microbiological Examination of Non-sterile Products 142
5.9 Elements to Consider for Raw Data Sheets 148
Acknowledgments 149
Bibliography 149
6 Microbial Requirements and Testing of Primary Packaging 153 Marcel Goverde
6.1 Introduction 154
6.2 Guidelines and Literature 161
6.3 Acceptance Criteria and Testing Frequency 164
6.4 Test Methods 170
6.5 Suitability Test 174
6.6 OOS Procedure 177
6.7 Examples of OOS or OOE Cases 178
6.8 Conclusion 184
Bibliography 185
7 Utilities Design and Testing 189 Tim Sandle
7.1 Introduction 190
7.2 Defining, Developing, and Maintaining Utilities 191
7.3 Review of Critical Utilities 198
7.4 Conclusion 226
Bibliography 227
8 Microbiological Environmental Monitoring 231 Alexandra Stärk
8.1 Introduction 232
8.2 Microbiological Control Strategy 233
8.3 Cleanliness Zoning Concept for Non-sterile Products 233
