Quality Risk Management and the role of Cognitive Solutions

Quality Risk Management (QRM) is a systematic process for the assessment, control communication, and review of risks to the quality of the pharmaceutical product across the product life-cycle.

It is especially critical in the pharmaceutical industry, where product quality can greatly affect consumer health and safety.

An effective quality risk management approach can further ensure the high quality of the drug (medicinal) product to the patient by providing a proactive means to identify and control potential quality issues during development and manufacturing.

The goal of QRM within the context of QbD is to identify the risks to product quality from a development perspective, identify the critical parameters of a formulation and process that most significantly affect the quality (CPPs and CMAs) and finally to reduce the level of risk by implementation of a Control Strategy. In the attached Figures the Risk Management Steps and tools are outlined. In summary, the implementation of appropriate Process Analytical Technologies (PAT) is fundamental part for securing the quality of the pharmaceutical products.