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.

Until these methods become official all Pharmacopoeias have allowed a transition time, e. g. the European Pharmacopoeia have proposed that the (old) Ph. Eur. method will remain the official valid method until 31st December 2008 while the methods in US Pharmacopoeia stay valid until 30th. April 2009.

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.

Not only already registered pharmaceutical products but also not yet released products have to be tested according to the new methods. As a consequence the harmonization requires that pharmaceutical companies revalidate each manufactured pharmaceutical product.

Usually three batches of each pharmaceutical product and not three batches of the culture media are used for this procedure.

In order to meet the criteria of the harmonized Pharmacopoeia Merck has implemented:

• The composition of the culture media as per the new USP chapter <62> and new EP chapter 2.6.13.
  
  
• Changes of existing culture media to be compliant with the pharmacopoeia requirements and introduction of new media to the pharma market (e.g. RVS, EE broth and XLD Agar).
  
  
• Quality control testing methods and specifications according to the new harmonized 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.