In March 2006, the EMEA published the "Reflection Paper on a proposed solution for dealing with minor deviations from the detail described in the Marketing Authorisation" for the first time. Its objective was to reflect EMEA's expectations whether a batch can be released under the circumstances described despite the occurrence of deviations. A year later, in April 2007 the EMEA formulated a number of questions in order to get feedback from the industry (and especially from the QPs) about the practical implementation. Based on this, the European QP Association (EQPA) started a survey among its members. Later the results were presented at the Interested Parties Meeting in London in September 2007. On this, the stakeholders gave a joint answer. Apart from the EQPA, among others the EFPIA and the PDA also participated in the presentation.
Now the EMEA has published an updated version of this paper, into which some of the points discussed have been integrated. Unfortunately, the adaptations are not as extensive as the meeting participants had desired. Maybe some might be taken into consideration in the revision of the Variations Regulation.
It is to be welcomed that it has now been clarified that the Reflection Paper also applies to investigational medicinal products. Here, it does of course not refer to the marketing authorisation, but to the approval for clinical trials (like e. g. the IMPD).
What has always been debated is the term and status of a "planned deviation". The new document is the first to deal with this expression. However, the opinion prevails that these planned deviations must be under the control of the quality system and are therefore not covered by the Reflection Paper. In any case, it has to be decided if it represents a variation before such a planned deviation is conducted.
All deviations must in any case be documented in a GMP-compliant way in the batch documentation.
In the final analysis, not much has changed. The EQPA's request to extend the scope to deviations from less critical product specifications has not been granted either.
The new document can be found here.
On behalf of the European Compliance Academy (ECA)