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Rapid Methods supplement 2011
In this Rapid Methods supplement: A regulators view; Nucleic acid and gene amplification-based technologies; Challenges and strategies for application in the pharmaceutical industry...
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Rapid Microbiological Methods (RMMs)
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Detection of microorganisms using cellular component-based rapid method technologies
20 June 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the third in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. In my last article, I provided an overview of viability-based rapid microbiological methods (RMMs), such as flow and solid-phase cytometry. In this article, we will review some of…
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Overview of rapid microbiological methods evaluated, validated and implemented for microbiological quality control
19 April 2011 | By Oliver Gordon, Jennifer C. Gray, Hans-Joachim Anders, Alexandra Staerk & Oliver Schlaefli, Novartis Pharma Stein AG and Gunther Neuhaus, University of Freiburg
The risk for patients through spoiled or otherwise adulterated pharmaceuticals has been acknowledged for many centuries and led to the establishment of Good Manufacturing Practice (GMP) and pharmacopoeial guidelines. Besides chemical purity, pharmaceuticals also have to meet microbiological standards, the latter primarily depending on the administration route. Drug products which…
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Article 1 Rapid microbiological methods 2011
16 February 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the first in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. Last year, I provided an overview of rapid microbiological methods (RMMs), including validation strategies, regulatory expectations, the technical and quality benefits of RMMs as compared with conventional techniques,…
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The implementation of rapid microbiological methods
This is the sixth and final paper in a series of articles on rapid microbiological methods that have appeared in European Pharmaceutical Review during 2010. Over the past year, we have explored the world of rapid microbiological methods (RMMs), focusing on validation strategies, regulatory expectations, and the technical and quality…
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Article 5: The implementation of rapid microbiological methods
1 November 2010 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the fifth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. In my previous four articles, I have provided an overview of the benefits of rapid microbiological methods (RMMs) as compared with conventional methods, validation strategies and regulatory perspectives…
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Article 3: The implementation of rapid microbiological methods
24 June 2010 | By Michael J. Miller, Ph.D., President, Microbiology Consultants, LLC
This is the third in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order…
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The implementation of Rapid Microbiological Methods (Article 1)
This is the first in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010.
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Real-time environmental monitoring: PAT solutions using rapid microbiological methods
In these economic times the pharmaceutical industry has expressed a renewed interest to explore ways in which to enhance the efficiency and agility of existing and future manufacturing processes. This is also true for laboratory-based operations that support forward processing and product release decisions. One function that can greatly benefit…
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Quality risk management and the economics of implementing rapid microbiological methods
Quality risk management (QRM) is an important part of science-based decision making which is essential for the quality management of pharmaceutical manufacturing1. The ICH Q9 guideline, Quality Risk Management2 defines QRM as a systematic process for the assessment, control, communication and review of risk to the quality of drug product…
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Implementation, validation and registration of rapid microbiological methods
19 June 2008 | By
Over the last decade, interest in rapid microbiological methods (RMMs) in the pharmaceutical sector has grown considerably. Technologies such as ATP bioluminescence, solid phase laser cytometry and genetic-based identification systems are being vigorously investigated. Validation and regulatory requirements for such new technologies are beginning to emerge. However, there is a…
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Microbiology / Microbiologists – Where next?
23 January 2008 | By Stewart Green Director of Quality, Wyeth, UK and Chair, Pharmig
Arguably microbiology is the oldest of the applied sciences, although early exponents doubtless had no understanding of how the fruits of their labour in fermentation for example, came about. The true forerunners of microbiology as it is recognised today would be Koch, Pasteur, Petri et al, who developed much of…
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Rapid microbiology: Solutions for the next stage
20 July 2006 | By Tim Lloyd, Editor, European Pharmaceutical Review
Rapid microbiology is an exciting field for the development of new technologies and applications. There are significant challenges to be overcome and in doing so, great prospects for microbiologists and the companies that provide cutting-edge equipment.
