New Requirements on the Validation of Sterility Tests

GMP News No. 386

12 February 2004

NewRequirements on
the Validation of Sterility Tests

At the beginning of 2004, the 6th supplement to the European Pharmacopoeiawith the harmonised text on sterility testing came into force.

This has led to changes that may be critical for many pharmaceuticalcompanies.

For the validation of sterility tests as well as for the test forgrowth-promoting properties, the EP now requires expressly that all of themicro-organisms listed in the text have to be taken into account. Inaddition, the incubation period for validation was standardised to5 days for both fungi and bacteria.

Another change that might make a new validation of the method necessaryin many cases are the new values for the minimum quantity to be testeddepending on the type of formulation.

Here we have mentioned only some examples for the consequences in orderto demonstrate that the publication of this supplement has brought aboutsignificant changes that have to be strictly observed in any case. 

The positive aspect - and for many the most important one - is that theextensive harmonisation of sterility testing in EP, USP and JP, has openedup the possibility to fulfil the requirements in the geographical scope ofthese monographs by performing one sterility test. 


Dr Ulrich Herber


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