Pharmaceutical NEWS - Fall 2008

Harmonized microbial limits testing becomes effective in 2009

In an effort to harmonize microbiological test methods between the major compendia, the United States (USP), European (EP) and Japanese (JP) Pharmacopoeias have agreed on new methods for microbial enumeration tests and tests for specified microorganisms. The harmonized methods, which are generally referred to as microbial limits testing, provide more detail than any of the earlier pharmacopoeia methods.

The new methods contain significant changes over earlier versions, including new techniques, media, incubation times and incubation temperatures. Because of these alterations, products previously validated under earlier methods need to be reevaluated. To remain compliant with the compendial requirements, adequate neutralization of the antimicrobial activity of products must be demonstrated. For products needing microbial limits testing in the future, it will be necessary to validate the specific product method using the harmonized microbial limits test methods. The validation proves the method conditions are appropriate for the specific product and that the dilution is not inhibitory to the organisms used in the test.

Lancaster Laboratories has significant experience performing the harmonized microbial limits test method. “We’ve been offering the harmonized methods for two years and have completed more than 200 product validations for more than 50 different clients,” says Mike Yunginger, manager of Non-Sterile Products at Lancaster Labs. Although new validations are needed for existing formulations, Yunginger explains that the change is beneficial because one method will now meet the requirements of any agency that recognizes either USP, EP or JP. He encourages clients to review their list of products that are currently validated and call their Lancaster Labs client service representative to make arrangements for revalidation of any products that will continue to require microbial limits testing after the effective dates for the harmonized methods. Having the validation completed prior to the effective dates for the methods will allow a seamless transition from the individual methods to the harmonized methods.

The implementation date for the new tests, originally scheduled for August 2007 in the US, was postponed to allow more time for users to comply and varies depending on the compendia. Use of the new methods will be required beginning January 1, 2009, for those who reference the EP methods (2.6.12 and 2.6.13), April 1, 2009, for the JP methods (4.05) and May 1, 2009, for the USP methods (<61> and <62>). These methods are currently approved for optional use and may be implemented prior to these effective dates.

For more information on testing using harmonized microbial limits methods, call Pharmaceutical Client Services at 717-656-2300.