Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Assignment of GMP data - within application dossiers and during external inspections
Ariane Prochaska (Abschlußjahr: 2007)
Good Manufacturing Practice ensures Quality, Safety and Efficacy of finished drug products. Compliance with GMP guidelines is routinely assessed by inspectors during on site inspections and by assessors during review of application dossiers. Different understanding and interpretation of GMPs through different competent authorities is a result of international marketing of drug products.
This master thesis presents the opportunities to simplify the presentation of GMP data basing on actual guidelines and with respect to the global harmonization trend.
EMEA, ICH and PIC/S are working close together to facilitate a common understanding of GMP standards and their interpretation: Mutual Recognition Agreements between European Community and third countries have been implemented to allow acceptance of GMP inspection reports and GMP certificates from other parties and to harmonize the GMP Annexes between EC and third countries. ICH is working on the harmonization of the quality aspects of CTD module 3. EMEA Inspection Sector and PIC/S have established a Joint Audit Programme to train the auditors in order to ensure a harmonized approach to audits and in further consequence to harmonize the conduct of inspections. The EudraGMP database will support further the inspectorates by exchange of information, and the Compilation of Community Procedures triggered by the EMEA provides a collection of GMP inspection related procedures and forms to facilitate the administrative collaboration between the competent authorities.
ICH has made a significant step with the recently issued guidelines Q8, Q9 and Q10, which may be regarded as framework for a modern quality system. Following the ICH concept a consistent product quality through each product life cycle is ensured. The assessment of application dossiers following Q8 will need a comprehensive knowledge about product development, life cycle and manufacturing process, since multidimensional correlations are presented instead of the traditional tables with process parameters and specifications. Any raw data or mathematical operations supporting the submitted Design Space will be on file and can be evaluated during on site inspections by the GMP inspector or by the Quality assessor itself.
Pages: 44