New Requirements on the Validation of Sterility Tests

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

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

For the validation of sterility tests as well as for the test for growth-promoting properties, the EP now requires expressly that all of the micro-organisms listed in the text have to be taken into account. In addition, the incubation period for validation was standardised to 5 days for both fungi and bacteria.

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

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

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

Inform yourself about these and further current GMP requirements in microbiological quality control at our GMP Education Course "Validation of Microbiological Test Procedures" taking place in Vienna, Austria, on 26-28 April 2004. Please click here to view the programme.