Issue 1 2010 / 22 February 2010 /
This is the first in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010.
Microbiology trapped in the 19th Century
When the science of microbiology was in its early stages of development, scientists used liquid media for the cultivation of microorganisms. For those who were in need of a method to segregate individual types of organisms, the use of liquid media proved to be a significant disadvantage. This was the case for Dr Robert Koch, who, in 1881, was determined to find an alternative method for his experiments. His laboratory first used aseptically cut slices of potato as a solid culture medium, and later turned to liquid culture supplemented with gelatin, which was subsequently poured into glass plates and allowed to solidify. This technique permitted the scientists to obtain pure cultures of the bacteria that were found to be growing in the form of discreet colonies on the surface of the plates.
(more…)
Issue 4 2009, Past issues / 30 July 2009 /
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 from implementing more efficient testing platforms and realise a significant return on investment (ROI) is the QC microbiology lab. This is especially apparent when the laboratory replaces conventional growth-based microbiology procedures with more efficient rapid microbiological methods (RMMs). (more…)
Issue 2 2009, Past issues / 20 March 2009 /
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 across the product lifecycle. Similarly, the FDA Final Report for Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach3, states that using a scientific framework to find ways of mitigating risk while facilitating continuous improvement and innovation in pharmaceutical manufacturing is a key public health objective, and that a new risk-based pharmaceutical quality assessment system will encourage the implementation of new technologies, such as process analytical technology (PAT), to facilitate continuous manufacturing improvements via implementation of an effective quality system.
The FDA’s PAT Guidance, which was finalised in 20044, describes a regulatory framework that will encourage the voluntary development and implementation of innovative approaches in pharmaceutical development, manufacturing, and quality assurance. Many new technologies are currently available that provide information on physical, chemical, and microbiological characteristics of materials to improve process understanding and to measure, control, and/or predict quality and performance. The guidance facilitates the introduction of such new technologies to improve efficiency and effectiveness of manufacturing process design and control, and quality assurance. A desired goal of the PAT framework is; therefore, to design and develop well-understood processes that will consistently ensure a predefined quality at the end of the manufacturing process, which is the foundation for the concept, that quality cannot be tested into products; it should be built-in or should be by design.
(more…)
Login to access exclusive content