to determine clearly and unambiguously the prerequisites for certification and release of a batch of medicinal product
to minimise misinterpretation
to clarify the extent of personal involvement of the QP versus reliance on quality systems and other personnel
to harmonise interpretations across Member States regarding when and where samples should be taken
to provide guidance on what is understood by certification of compliance with the Marketing Authorisation with
respect to the Reflection Paper published by EMA on the QP's discretion when dealing with minor deviations from the details described
in the Marketing Authorisation
to explore implications of new legislation related to active pharmaceutical ingredients (APIs), excipients and
to ensure that the guideline is up-to-date concerning investigational medicinal products (IMPs
There are a number of additional areas where clarifying guidance regarding the QP is strongly desired, e.g.:
The QP's position in an organisation's structure
The physical location of the QP
Independence of the QP from the Head of Production Manager and/or Quality Control
The QP's role in product defects and related investigations
End of consultation (deadline for comments) will be 31 January 2012. On November 23rd, there is an Interested Parties Meeting with EMA's
GMDP Working Group in London on the revision of Annex 16. The European QP Association will be actively involved in the upcoming
discussion. Therefore the European QP Association will provide a presentation at the next Interest Parties Meeting with EMA. The
outcome of the Interested Parties Meeting will be presented at the QP Forum in Budapest from 1-2 December .