Get Ready for the New Harmonized Pharmacopoeia
With Merck’s high-quality DCM product portfolio, you can easily meet all requirements of the new harmonized microbiology test methods
As the first supplier of pharmaceutical materials worldwide, Merck offers you a wide selection of Dehydrated Culture Media (DCM) meeting the requirements of microbial limits test methods according to the new internationally harmonized pharmacopoeia. With Merck’s new, high-quality DCM product portfolio, pharmaceutical companies are finally able to start the required tests to establish method suitability that have to be concluded until the end of 2008.
Merck product portfolio meets all criteria of the harmonized pharmacopoeia
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As a reliable partner for pharmaceutical companies, Merck supports its customers in meeting the new requirements of the harmonized pharmacopoeia: Merck is able to provide you a comprehensive product portfolio of qualified Dehydrated Culture Media for microbiological control of pharmaceutical products.
Harmonisation of General Microbiology chapters
The goal of global pharmacopoeia harmonisation is to promote consistency of microbiology methods used by companies throughout the world. The 6th Supplement to the Ph. Eur. 5th edition (chapters 2.6.12 and 2.6.13) contains detailed descriptions of the methods for microbial enumeration tests and tests for specified microorganisms, harmonized with regulations in the USA and Japan. Among other modifications, the harmonized methods provide much more detail in terms of demonstrating method suitability (method validation) and media-growth promotion.
Pharmaceutical companies must act
The European Pharmacopoeia has proposed that until December 31, 2008 the Ph. Eur. methods will remain the official valid method, but either the Ph. Eur. methods or the new harmonized methods may be used. For new applications for products not covered by a monograph, however, use of the harmonized methods is recommended.
Based on changes in the harmonized chapters, registered products may need to be revalidated due to differences in e.g. media requirements, testing conditions or amount of sample to be used. Until the harmonized methods become the official reference methods, they should be shown by the manufacturers to be suitable to replace the Ph. Eur. method for all registered products. The harmonized European Pharmacopoeia specifies that manufacturers have to establish the ability of the test to detect micro-organisms in the presence of the product to be tested. Companies should undertake all suitability tests and revalidations in due time before the new harmonized methods go into effect in 2009.
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