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3 July 2008

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 regulatory department.

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 invented.

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.

The detailed survey results can be found here.

Dr Bernd Renger
Chairman, European Qualified Person Association

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