Pharmaceutical Microbiological Quality Assurance and Control (eBook)

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.

Editors

List of Contributors

Preface

Acknowledgments

Chapter 1: Microbiological control strategy

Chapter 2: Microbial contamination risk assessment in non-sterile drug product manufacturing and risk mitigation

Chapter 3: Qualification of Microbiological laboratory personnel and equipment

Chapter 4: Introduction to culture media in pharmaceutical microbiology for non-sterile products

Chapter 5: Microbiological examination of non-sterile final dosage forms and raw material including acceptance criteria and testing frequency

Chapter 6: Microbial requirements and testing of primary packaging

Chapter 7: Utilities design and testing

Chapter 8: Microbiological Environmental Monitoring

Chapter 9: Identification of microorganisms

Chapter 10: Calculating alert levels and trending of microbiological data

Chapter 11: Exclusion of objectionable microorganisms from non-sterile pharmaceutical drug products

Chapter 12: Data integrity and microbiological excursion handling

Chapter 13: Rapid microbiological methods

Chapter 14: Validation of a rapid microbiological method for the microbiological examination of non-sterile and non-filterable drug products, APIs and excipients

Chapter 15: An Ex-Regulator's View of the Microbiology QA/QC Functions in the US Pharmaceutical Industries

Chapter 16: Practical guide for microbiological QA/QC of non-sterile pharmaceuticals manufacturing for EU

Chapter 17: Which microbiological tests can better be performed in-house and what can be easily outsourced