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Rapid microbe testing a must for industry

09-Jun-2003

Related topics: Packaging

A meeting organised by the UK Medicines and Healthcare products Regulatory Agency has heard calls for rapid microbiological methods (RMM) - such as laser scanning flow cytometry, bioluminescence, polymerase chain reaction technology and mass spectroscopy - to be used routinely in the pharmaceutical industry for drug development, manufacturing and quality assurance.

"RMM offer substantial advantages over conventional methods of for speed of the tests and should be an integral part of process analytical technology and process understanding," said the MHRA in a review of its latest New Technologies Forum, one of a series of meetings designed to bring industry and regulators together.

MHRA representatives at the Forum sought to persuade industry to adopt RMM techniques, and noted that companies should develop their own validation packages for the techniques, under all the conditions that are likely to be encountered in practice, rather than relying on literature provided by suppliers.

In addition, the reasons for the differences in results achieved with RMM compared to conventional microbiological techniques should be addressed in order to develop acceptance criteria for the techniques, and more academic research on RMM should be encouraged, according to the MHRA.