Using Knowledge Work Intensity Assessment to Improve the Effectiveness of Quality Assurance in New Drug Development

Research and development of new pharmaceutical products are very knowledge-intensive activities, which require an efficient quality assurance process. The trade-off between quality and time to market is increasingly critical, which generates stress in the face of the risks associated with delays in quality assurance or even longer delays if the regulatory agency rejects the proposal. To help resolve this dilemma in a company involved in the research, production and marketing of biopharmaceuticals, we assessed the knowledge intensity required for quality assurance. This was achieved by breaking down the quality assurance process into tasks and evaluating each of these tasks according to the dimensions of required qualification, autonomy, innovation, information intensity, interdependencies and decision variability. The most demanding dimensions founded in the study were information intensity and innovation, while level of autonomy was low. A content analysis technique was incorporated to uncover the knowledge present in the many documents of past technical reviews. This revealed the main sources of delays in past quality assurance processes and support findings proactive decisions. The working system was redesigned to facilitate the harmonisation of criteria and the presentation of the scientific basis of the results, thereby strengthening interdependencies, information analysis, innovation capacity and qualification.