Media for New Harmonized Microbiology: Microbial Limits Test
After years of discussion between microbiologists in the US, Europe and Japan there is now for the first time ever a harmonized testing procedure available for microbiological quality control. In the future, these Pharmacopoeia methods will use identical media, test organisms and performance test parameters in the US, in Europe and Japan.
Before harmonization comes into effect, pharmaceutical laboratories must present evidence for registered products that the new methods are suitable to replace the current methods. At least for Europe and the US, after the deadlines described above, only the new harmonized methods will be the official EP/US Pharmacopoeia methods.
This process is now completed and Merck can currently offer to all pharmaceutical customers a product portfolio meeting the requirements of the new harmonized microbiology microbial limits test methods.
Source: Merck Millipore View latest company information
Posted: September 3, 2007
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