Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing
- 10h 14m
- David Roesti, Marcel Goverde
- John Wiley & Sons (US)
- 2020
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
- 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
About the Authors
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.
In this Book
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Foreword
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Microbiological Control Strategy
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Microbial Contamination Risk Assessment in Non-Sterile Drug Product Manufacturing and Risk Mitigation
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Qualification of Microbiological Laboratory Personnel and Equipment
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Introduction to Culture Media in Pharmaceutical Microbiology for Non-Sterile Products
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Microbiological Examination of Non-Sterile Final Dosage Forms and Raw Material Including Acceptance Criteria and Testing Frequency
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Microbial Requirements and Testing of Primary Packaging
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Utilities Design and Testing
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Microbiological Environmental Monitoring
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Identification of Microorganisms
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Calculating Alert Levels and Trending of Microbiological Data
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Exclusion of Objectionable Microorganisms from Non-Sterile Pharmaceutical Drug Products
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Data Integrity and Microbiological Excursion Handling
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Rapid Microbiological Methods
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Validation of a Rapid Microbiological Method for the Microbiological Examination of Non-Sterile and Nonfilterable Drug Products, APIs, and Excipients
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An Ex-Regulator's View of the Microbiology QA/QC Functions in the US Pharmaceutical Industries
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Practical Guide for Microbiological QA/QC of Non-Sterile Pharmaceuticals Manufacturing for EU
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Which Microbiological Tests Can Better Be Performed In-House and What Can Be Easily Outsourced
