The updated general chapter 5.1.6 provides a modernised text intended to streamline implementation for users.
The European Pharmacopoeia Commission has issued a new revised general chapter on alternative microbiological methods, supporting advancement of the field by modernising quality standards.
The revised chapter 5.1.6. Alternative methods for control of microbiological quality was published in Issue 13.2 of the European Pharmacopoeia (Ph. Eur.).
The Commission has updated the description of technologies to include modern approaches, removing outdated quality control methods. It means the framework offers a clearer definition of the responsibilities of suppliers and those using the chapter.
This change aligns with an earlier publication from the Eur. Ph. In January, it published a new general chapter on quality of data 5.38. The framework aids stakeholders with digitalisation during pharmaceutical quality decision-making.
As demand increases for alternative microbiological methods, especially for those that can provide rapid, simultaneous viable quantitation and microbial identification, among other technologies, AI offers potential to accelerate the field. Yet upfront cost, as well as the limited pool of qualified operators, are among the main factors limiting its widespread use.
Moreover, in the current revised chapter, multiple validation strategies, based on a risk assessment, have been added to enhance its implementation. For example, leveraging relevant existing data and enabling multiple implementation activities to be assessed simultaneously.
This revised general chapter comes into force on 1 April 2027.
As industry bodies such as the EDQM work to improve their quality oversight of microbiological approaches, the industry itself continues to make advancements.
Research conducted earlier this year suggests that loop-mediated isothermal amplification (LAMP) could provide a rapid, alternative detection method to culture-based surface monitoring approaches. Compared to quantitative PCR (qPCR), which can take several days, LAMP offers a turnaround of only 30 to 60 minutes.
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