A Semiquantitative Risk Assessment Methodology Fit for Biopharmaceutical Life Cycle Stages

This paper introduces an innovative risk assessment tool, a semiquantitative risk determination (SQRD) method designed to address risk on the operational and organizational level with a distinct patient safety perspective. Quality Risk Management (ICH Q9) is a systematic process for the assessment, control, communication, and review of risks to the quality of the drug (medicinal) product across the product life cycle. SQRD is a systematic data-driven risk assessment tool. It is of practical significance to have a risk assessment tool that directly links to patient safety attributes. The SQRD methodology has six distinctive steps that are customized to address patient impact and non-patient impact quality attributes. The target was to develop and utilize an advanced risk assessment tool that is reliable, robust, objective, and data-driven. SQRD can be applied to batch production, continuous process, or a hybrid of the two, and at any stage of the product life cycle such as early development, pilot formulation development, process validation, or commercial manufacturing. The output of SQRD can help in shaping and optimizing the product control strategy. The exercise enables systematic mitigation of the identified risks. The proposed SQRD tool systematically evaluates data and scientifically establishes reliable, robust, and efficient risk assessments.