European Qualified Person Association publishes Results
of a Survey on Monitoring of Changes
According to Article 51of the European Directive
2001/83/EC as amended by Directive 2003/63/EC and Directive 2004/27/EC,
the qualified person is responsible for securing that "in the case of
medicinal products manufactured within the Member States each batch of
medicinal products has been manufactured and checked in compliance with
the laws in force in that Member State and in accordance with the
requirements of the marketing authorization."
Tracking of product specifications and regulatory files may be a
manageable task in smaller companies where the QP has close links to the
regulatory department. When it comes to companies with permanent global
change activities this task becomes more and more complex and may only
be manageable by either using IT solutions or defining processes keeping
the QP informed about any relevant changes
As more and more inspections ask for evidence that the QPs certifying
batches have checked regulatory compliance of product and production
processes it becomes more and more vital for QPs to assure these tools
are in place.
The European QP Association was contacted to initiate a questionnaire to
find out whether the company's regulatory department have some system in
place ensuring that the actual status filings or changes of products is
monitored and in compliance.
The results of the first and most crucial question
Do you have access to an electronic or paper based system that allows
you to check the actual status of filings and changes on a global basis
of all the products you certify?
must be considered somewhat worrying, as only 41 % of the 183
respondents confirmed that they have access to an adequate system.
However, reassuringly a high number of 65 % of the negative answering
respondents to the first question confirmed in the following part 2 of
this question that there is an appropriate system in place within their
According to the second question QPs do ensure themselves that they only
certify batches that have been manufactured according to the actual
marketing authorizations in nearly equal shares by either regularly
checking of manufacturing and testing documents together with regulatory
department, active participation in change control boards or signing-off
on any changes to the registered specification.
Products already released and sitting in distribution centres, however
is checked for compliance with latest regulatory changes in the
particular country only in app. 52 % based o checks of the batch
documentation or the labelling, whereas nearly 48 % will eave the
distribution centres unchecked.
The results of this survey clearly indicate that companies have
strategies in place to keep QPs in the loop when it comes to pass
information concerning changes in the registration files. However, the
ideal solution or tool to support QPs in one of their most prominent
responsibilities, ensuring that batches certified fully comply with he
marketing authorisation in the appropriate country has yet to be
Somewhat more worrying are the results concerning the surveillance of
batches already certified and sitting in distribution centres. Here
seems to be considerable room for improvement.