Masterstudiengang "Drug Regulatory Affairs"


How to achieve and maintain compliance for quality documents in a global company ***

Andrea Krause (Abschlußjahr: 2010)

Language: English

The maintenance of compliance for quality documents is a key requirement for a marketing authorisation holder.
Legal requirements and guidelines in the regulatory environment have changed over the years. This fact creates a specific situation especially for nationally authorised medicinal products being on the market for a long time. Due to the differences in the national approaches to obtain a marketing authorisation a global acting company faces challenges to maintain compliance within the CMC (Chemistry, Manufacturing and Control) documentation according to each country`s approved conditions.

The challenges to reestablish regulatory compliance for quality documents of older products are outlined and a central model to this approach in a global acting pharmaceutical company is introduced in this paper.
For the marketing authorisation holder it is fundamental to know about the currently registered status for quality documents in each country. If this is not the case the status needs to be assessed. Since July 2003 registration documents in the ICH regions need to be provided according to the CTD (Common Technical Document) format. For older national marketing authorisations in the EU a further challenge might be that the approved documentation is only available in the NtA Part II format.

A Compliance assessment is a tool to describe and understand how far the current registered status of a medicinal product is deviating from the actual way of manufacturing, testing and packaging of this product at the manufacturing site. A decision analysis can help to identify the right documentation to be used as comparator for the assessment.

Findings can be grouped in risk categories and a corrective action plan needs to be developed.

If regulatory changes are needed a regulatory submission strategy needs to be developed. Since 01 January 2010 it is mandatory in the EU to follow the New EU Variations Regulation and the accompanying guidelines for centralised, mutual recognition and decentralised procedures, and some member states also apply the New Regulation to national applications at the moment. This divergent situation complicates the development of a submission strategy for national marketing authorisations.

A compliance check on nationally approved medicinal products provides also a good opportunity to think about harmonisation. It could be useful and efficient to combine both. However there are limits of harmonisation and risks related to this approach.

With respect to the preparation of the variations it is essential for a global acting pharmaceutical company to think about resources and priorities. A global compliance program will be a huge workload in addition to the day to day work.

To maintain compliance a Change Control management system needs to be in place at the manufacturing site. In addition to this a data management system is an important tool to guarantee compliance.

Pages: 57