Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

CMC Documentation Contemplation on regulatory requirements in relation to the maintenance of drug products concerning life cycle and change management

Britta Neubauer (Abschlußjahr: 2008)

Language: English

The manufacturing and control of drug products generally has two essential aspects: On one hand the medicinal product should be produced and controlled complying with all relevant GMP/GLP Regulations and on the other hand a dossier for marketing authorization should only contain product specific information.

The Master-Thesis highlights requirements in CMC documentation and gives examples how to cope with the balancing act between regulatory requirements and avoidance of unnecessary changes in CMC documentation. Moreover an impression of ICH Q8 in relation to the options and challenges of "quality by design" for CMC documentation is presented.

The relevant documentation requirements for the compilation of the CMC documentation and the stipulated structure as defined in NTA, Volume 2B and relevant ICH resp. CHPM guidelines are illustrated on documentation examples for two options:

• Option 1: Development drug product with planned first Marketing Authorization
• Option 2: Drug product that was authorized nationally in several EU member states several years ago

The submitted information in the applied dossier is legally binding. In both options any amendment to the approved documentation of the drug product has to be checked and well considered during the life cycle of the product before implementation of a change. The implementation of design space according to ICH Q8 offers the opportunity of documented knowledge of processes that are critical to the product quality e.g. manufacturing processes.

To date most of the marketing authorizations are still national ones. For these "old" drug products every avoidable change in documentation brings additional unnecessary expense. The new Commission Regulation on variations hopefully provides an approach for a more flexible change management system in EU and contributes to harmonized regulatory requirements within the whole EU.

Pages: 51