Risk-based Modelling in Monitoring the Qulity of Pharmaceutical Products

According to WHO reports, low quality medicines represent about 10% of the global pharmaceutical market of which about 40% were substandard medicines. Most of the studies of quality of medicines recommend development of additional innovative techniques to control the existence of substandard medicines in the market. Based on recent assessment by WHO, systems applied to detect substandard and/or counterfeit medicines in developing countries were not effective enough. A strong post marketing surveillance system would be a more powerful tool for detecting sub standard medicines. In some countries, it was proven that strengthening the system by applying risk-based model for supporting the decisions is useful and possible approach. This exploration work aimed at exploring possible options to develop a risk-based quality monitoring model for pharmaceutical products. The model proposed based on this review work should help medicines regulatory authorities in resource limited settings to improve surveillance systems. The model was tested for its usefulness and effectiveness and the results obtained showed potential applications of the model in improving the system. This would include its use in the selection technique of products for inclusion in post-marketing quality monitoring. It can also be applied to increase the detection rate of low quality products.