Alternative methods for control of microbiological quality

The European Pharmacopeia is to completely revised the chapter “Alternative methods for control of microbiological quality”. This is chapter 5.1.6 and is the chapter relating to rapid and alternative methods. A draft has been published in the current edition of Phareuropa and it is available for public comment.

The introduction to the revised document reads:

“The objective of this chapter is to facilitate the implementation and use of alternative= microbiological methods where this can lead to efficient microbiological control and improved assurance for the quality of pharmaceutical products. The microbiological methods described in the European Pharmacopoeia have been used for over a century and these methods for detecting, enumerating and identifying micro-organisms still serve microbiologists well. Over the years, these methods have been invaluable for the production of microbiologically safe pharmaceutical products. However, conventional microbiological methods are slow, and in the case of sterility tests, results are not available before an incubation period of 14 days. Consequently, the results from these conventional methods seldom enable proactive corrective action to be taken.

Alternative microbiological methods for the control of microbiological quality have been introduced in recent years, and some of these methods have shown potential for real-time or near real-time results with the possibility of earlier corrective action. These new methods, if validated and adapted for routine use, can also offer significant improvements in the quality of testing. Alternative methods may be used for the application of Process Analytical Technology (PAT) to in-process samples of pharmaceutical products and for environmental monitoring, thereby contributing to the quality control of these products.”

The revised chapter includes sections on:

• General critical aspects of methods based on early detection of growth
• Electrochemical methods
• Measurement of consumption or production of gas
• Bioluminescence
• Turbidimetry
• Growth detection using selective and/or indicative media
• Solid phase cytometry
• Flow cytometry
• Direct epifluorescent filtration technique (DEFT)
• Autofluorescence
• Phenotypic techniques
• Genotypic techniques
• Validation of alternative microbiological methods

The chapter is available for review via Pharmeuropa. You will need to register in order to comment.

Pharmeuropa is a free online EDQM publication. Draft monographs are published in Pharmeuropa for public enquiry, which lasts for three months. Comments received are processed by EDQM, at this stage the draft can be amended and republished. If no further revision is required the draft monograph is proposed to the European Pharmacopoeia Commission if adopted an implementation date is given and this is about one year after the adoption of the monograph. The monograph is then published in the European Pharmacopoeia (or supplement). The monograph is published about 6 months after adoption. Therefore draft text appearing in Pharmeuropa may not become official for up to 2 years. Those monograph’s adopted will be highlighted in reviews of the European Pharmacopoeia or supplements

Posted by Tim Sandle