The European GDP Association is quite active in supporting its members. What has been achieved in 2019 so far?
Guideline interpretation
EQPA has finalised the Position Paper “QP responsibilities in the implementation of safety features (as per Directive 2011/62/EU)” aligned with EIPG. The main purpose is to clarify that the QP has no responsibility on electronic data handling/management after certification related to serialisation.
The paper was also discussed at an EMA-IWG Interested Parties teleconference on 16 January (by Ulrich). It is available for EQPA members in the download section of the website.
Surveys
Using Interactive Response Technology (IRT) to manage the use-by date is especially helpful in early clinical phase when there is limited stability data available, e.g. biological IMPs, ATMPs, refrigerated or frozen IMPs. EMA’s “Reflection paper on the use of IRT in clinical trials, with particular emphasis on handling expiry dates” outlines what National Competent Authorities expect from such systems. Appendix I to this reflection paper provides a “QP declaration template on use of IRT in the event of use for handling expiry dates” for IMPD submission.
The IMP Working Group asked the IMP QP members which European countries accepted IRT management of use-by dates including the IRT QP declaration and thus currently accept that no expiry date is printed on the label.
The IMP Working Group also has sent out a question with regards to the use of Interactive Response Technology (IRT) to manage the use-by date in early clinical phase. The Working Group is still interested in gathering more collective experience of the IMP QP members and is specifically interested in learning which European countries accepted IRT management of use-by dates including the IRT QP declaration and thus currently accept that no expiry date is printed on the label.
Meetings
The IMP Working Group has met in Brussels to start discussing the programme for the QP Forum.
Events
The programme for the Qualified Person Forum 2019 was published (27-29 November 2019, Munich).
Article
Georg Göstl has written an article for the EQPA Membership Letter on “Serialization and QP-Responsibilities”. The article was reviewed by Ulrich Kissel.
