EMEA Plans Amended Guideline on Parametric Release

On 26 November 2008, the EMEA published a concept paper on the revision of the Guideline on Parametric Release. The deadline for comments on this paper is February 2009.

The existing Guideline on Parametric Release has dealt in essence with replacing sterility testing in final product testing (release for the market). With the ICH Guidelines Q8, Q9 and Q10, however, the approach has to be much more comprehensive. The principles of Quality by Design, PAT and Real-Time Release have not been taken into account in the guideline. This is meant to be changed. With the extension of the scope of parametric release, not only for sterility testing, but generally all final product tests are intended to be omissible if the requirements laid down in the guideline have been implemented. With the revision of the current guideline, the requirements on the tests of batches imported from third countries into the European Union are also planned to be dealt with, since the advantage of the introduction of the parametric release is more or less inexistent if the test according to the product specifications has to be performed once more after the import into the EU even if parametric release was approved by an EU authority.

The Concept Paper on Parametric Release can be found here.

The FDA had published a Guidance for Industry regarding parametric release within the framework of an application for a marketing authorisation in August 2008. More information can be found in our GMP News of 10 September 2008.

Compiled by:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

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