Quality Risk Management (QRM) Considerations for Introduction of New Products

Abstract

Quality Risk Management (QRM) is an optional tool to improve product effectiveness and safety by assuring that the recognized risk is at a desired level. Also risk management tools provide a methodology to evaluate risk levels and prioritize on risk mitigation and risk control strategies. For this design project an evaluation was performed to identify the factors and considerations that could be adopted from the QRM methodology during the technology transfer process and new product introductions. The technology transfer approach was used to see possible risks and take on preventive actions to mitigate risk and avoid to inherit the risks throughout product life cycle. ICH Q9 was used as a guide for risk assessment during a pilot program on whole to ICH Q10 Pharmaceutical Quality System. An evaluation was conducted by determining risk prioritization numbers during the different new product introduction stages. It was noticed that as the new product introduction process progressed closer to commercial manufacturing, launch and distribution, the risk decreased which was a result of increased process detectability and reduced occurrence. Key Terms- FMEA, New Products, Quality Risk Management, RPN, Technology Transfer