e0f7c185-caa9-4978-a00f-6b6215c53a8b.jfif

## Quality - The degree to which a set of inherent properties of a product, system or process fulfills requirements ## Pharmaceutical Quality System - Management system to direct and control a pharmaceutical company with regard to quality. ## Quality System - The sum of all aspects of a system...

## Quality - The degree to which a set of inherent properties of a product, system or process fulfills requirements ## Pharmaceutical Quality System - Management system to direct and control a pharmaceutical company with regard to quality. ## Quality System - The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met. ## Quality Risk Management - A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. ## Change Management - A systematic approach to proposing, evaluating, approving, implementing and reviewing changes. ## Product Realisation - Achievement of a product with the quality attributes appropriate to meet the needs of patients, health care professionals, and regulatory authorities and internal customers' requirements. ## Risk - The combination of the probability of occurrence of harm and the severity of that harm. ## Risk Acceptance - The decision to accept risk ## Risk Analysis - The estimation of the risk associated with the identified hazards. ## Risk Assessment - A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards. ## Risk Communication - The sharing of information about risk and risk management between the decision maker and other stakeholders. ## Risk Control - Actions implementing risk management decisions. ## Risk Evaluation - The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk. ## Risk Identification - The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description. ## Risk Management - The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating and reviewing risk. ## Risk Reduction - Actions taken to lessen the probability of occurrence of harm and the severity of that harm