user requirement statement GMP PIC/s 13

EU publish concept paper on revision of Annex 17 “Parametric Release”

This concept paper addresses the need to update Annex 17 (Parametric release) of the EU GMP Guide. At the time the original guideline was adopted (January 2002), the main foreseen application area was sterility testing, with a particular focus on the release of terminally sterilised medicinal products. Since then, there have been significant changes in GMP consequent to the adoption of the ICH Q8, Q9 Q10 and Q11 guidelines. Furthermore, the Quality Working Party has recently published a Guideline on Real Time Release Testing.

The current Annex 17 is therefore being reviewed in order to implement the concepts highlighted in the aforementioned ICH guidelines and to extend the underlying concepts to areas other than sterility testing. The revision should also take into account related changes in other GMP chapters and Annexes as well as in other regulatory documents.

It is widely recognised that quality cannot be tested into a product, but it should be built-in through design with an understanding of both the product and the process used to make it. The revised guideline will clarify to what extent Q8, Q9 Q10 and Q11 should be followed in order to implement Real Time Release testing (RTRT). Moreover, it will detail how to set a system of release that provides assurance that the product or active substance is of the intended quality, based on the information collected during the manufacturing process, through product knowledge and process understanding and control.

The current guideline is only focused on the application of Parametric Release for the routine release of terminally sterilised products waiving the carrying out of a sterility test, on the basis of successful demonstration that predetermined and validated sterilising conditions have been achieved. This approach is based on the assumption that a sterility test only provides the opportunity to detect a major failure of the sterility assurance system, which would be more reliably detected by other means. Although the current guideline already states that the control of certain specific parameters may be used as an alternative to routine end-product testing of medicinal products, hence allowing the application of parametric release to any stage of manufacturing and to any type of products, detailed information is only provided for its application to terminally sterilised medicinal products. The main aim of the new guideline will be to facilitate the application of the concept to other processes, including the manufacture of biologics, active substances and intermediates.

The proposed date for the release of the draft guideline is December 2013; with the expected date for adoption by Committee is October 2014. No adverse impact on Industry with respect to either resources or costs is foreseen.

Information obtained from Concept paper on revision of Annex 17 of the GMP guide.