SAS 2 Flashcards
The inherent properties of a product that fulfills a system.
Quality
Management system to direct and control a pharmaceutical company about quality
Pharmaceutical quality system
The sum of all aspects of a system that implements quality policy
Quality system
A systematic process for assessment, control, communication and review of risk to the quality of the drug product across the product lifecycle
Quality risk management
A systematic approach to proposing, evaluating, approving, implementing and reviewing changes.
Change management
Achievement of a product with the quality attributes approved by the general standard.
Product realisation
The combination of the probability of occurrence of harm and the severity of the harm.
Risk
The estimation of the risk associated with the identified hazards.
Risk analysis
A systematic process of organizing information to support a risk decision to be made within a risk management process.
Risk assessment
The sharing of information about risk and risk management between the decision maker and other stakeholders.
Risk communication
Actions implementing risk management decisions
Risk control
The comparison of the estimated risk to a risk criteria through qualitative or quantitative way.
Risk evaluation
The systematic use of information to identify potential sources of harm
Risk identification
The systematic application of quality management policies, procedures, and practices to the task of assessing, controlling, communicating and reviewing risk.
Risk management
Review or monitoring of results of the risk management process considering new knowledge and experience about the risk.
Risk review
