Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Challenges Due to Globalisation of Drug Development and Manufacture Focusing on the Quality of Medicinal Products ***

Katrin Wengenroth (Abschlußjahr: 2011)

Language: English

The globalisation in the development and manufacture of medicinal products and drug substances is increasing. Due to high costs for research and development, international competition, reduced life time of products and austerity measures of health policy cost saving considerations are a big concern for pharmaceutical companies.

This pressure in pricing and competition leads to development and manufacture in lower cost countries like India and China.

The quality of medicinal products is the base for safety and efficacy. Past incidents with substandard medicinal products particullary point out that quality defects of medicinal products can harm patients.

This thesis deals with the challenges for the quality of medicinal products which are caused by globalisation of development and manufacture and on how to handle these challenges.

The challenges for the quality of medicinal products which are evoked by globalisation include the assurance of Good Manufacturing Practice compliance, new impurities in drug substances induced by alternative manufacturing routes, long lasting transports of drug substances and medicinal products passing various climatic zones, complex supply chains and product transfers.

In a globalised world cooperation and harmonisation are of course the best approaches to handle the challenges connected to globalisation. The European Union had a pioneering role in harmonisation activities. The International Conference on Harmonisation, the Pharmacopoeial Discussion Group (PDG), the World Health Organisation are some of the organisations which are engaged in the harmonisation of requirements. The European Medicines Agency cooperates with various authorities and organisations. Intensive collaboration is conducted with the United Staates Food and Drug Administration.

An approach on how to deal with the challenges of transportation in a mid-sized pharmaceutical company is proposed in this thesis. The main factors which might influence the quality of medicinal products are discussed. Subsequently a worst-case approach using the concept of the Mean Kinetic Temperature is proposed assuming an extreme transport temperature. A maximum acceptable transport time for uncontrolled transports is calculated. It is proposed that transports which are finished within the maximum acceptable transport time can be transported without any further precautionary measures.

Transports exceeding the maximum acceptable transport time according to the worst case approach need to be assessed in detail in order to find the best transport conditions, considering the characteristics of the specific product and the transportation route. Decission analysis has proven to be an adequate tool to figure out the best transport conditions for a transport of a specific medicinal product when it is anticipated that the maximum acceptable transport time is exceeded.

Decision analysis and cause and effect analysis have proven to be suitable tools to liase with complex challenges as shown in the approach for transportation of medicinal products. These tools would certainly be valuable to handle further globalisation challenges too.

Pages: 77