QbD Definitions
QbD Definitions
- Quality-by-Design (QbD): a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management
- Quality Target Product Profile (QTPP): a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product.
- Quality Attribute (QA): a physical, chemical, or microbiological property or characteristic that directly or indirectly relates to pre-defined product quality (safety, identity, strength, purity, and marketability of the product) .
- Critical Quality Attribute (CQA): a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure product quality
- Process Parameter (PP): a process variable (e.g., temperature, compression force) that can be assigned values to be used as control levels or operating limits.
- Critical Quality Parameter (CPP): a process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces desired quality
- Design Space (DS): the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality
- Control Strategy (CS): a planned set of controls, derived from current product and process understanding that ensures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring or control.
- Quality Risk Management (QRM): a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle
- 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
- Process Analytical Technologies (PAT): a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of assuring final product quality
- Process Performance and Product Quality Monitoring System: a system for the monitoring of process performance and product quality to ensure a state of control is maintained
- Corrective Action and Preventative Action System: a system for implementing corrective actions and preventative actions resulting from an investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring
- Change Management System (CMS): a systematic approach to proposing, evaluating, approving, implementing and reviewing changes
References
ICH Q8 (R2) – Pharmaceutical Development
ICH Q9 – Quality Risk Management
ICH Q10 – Pharmaceutical Quality System