GMP „Quo vadis?“ Entwicklung eines spezifischen Bewertungstools „GMP-DAKS-Σ“ für die qualitative und quantitative Analyse von GMP-Systemen in onkologisch herstellenden Apotheken

The aim of the present dissertation is to verify how GMP guidelines contribute to the strategic positioning of pharmacies producing carcinogenic, mutagenic and reprotoxic substances (CMR) and by which measurable indicators these pharmacies are characterised before and after implementation of a GMP system. All scientific investigations required to answer the research question were performed in carefully selected oncology pharmacies using the analysis tool GMP-DAKS-Σ which was developed within the scope of this work.
The input parameters for the GMP-DAKS-Σ tool, i. e. so-called GMP indicators, were extracted using qualitative research interviews conducted with experts.
The number of research interviews covers 60 percent of the Austrian market of the GMP-compliant production of carcinogenic, mutagenic and reprotoxic substances. The linguistic data collected during the qualitative interviews were processed by means of rule-governed content analysis of Mayring and the extract entered into the GMP-DAKS-Σ analysis tool. In order to link these findings to valid data of the prestigious British Medicines and Healthcare Products Regulatory Agency (MHRA), published GMP-Inspection-Deficiencies of the MHRA were extracted, processed and entered into the GMP-DAKS-Σ as reference values. This analysis tool was validated by means of an audit and enables automatic conversion of practice-oriented raw data collected in the oncology public and hospital pharmacy from qualitative into quantitative results by means of a catalytic converter with subsequent comparison and processing using Six Sigma.
Explorative data analysis by means of GMP-DAKS-Σ evaluation revealed that measurable improvements of the pharmaceutical quality management systems were achieved in the respective oncology pharmacies as determined with different methods depending on the specified evaluation criterion. Detailed analysis of the collected data leads to the conclusion that oncology hospital pharmacies have a higher base level as compared to oncology public pharmacies already partly fulfilling GMP success criteria. This can be attributed to synergy effects, e. g. central purchasing, personnel management or maintenance and repair that are necessary for a successful implementation of a pharmaceutical quality management system. In the light of the information provided, it may therefore be concluded that – due to different framework conditions regarding the provision of labour- and cost-intensive resources – it is far more difficult for a public pharmacy to implement a pharmaceutical quality management system than for a producing hospital pharmacy.