Critical Material Attributes: Material properties that must be controlled to ensure consistent process performance and product quality.
Category: Pharmaceutical
A planned set of controls derived from current product and process understanding that ensures process performance and product quality.
Critical Process Parameters: The process parameters that have a significant impact on CQAs and need to be controlled.
Critical Quality Attributes: The properties of a drug product that need to be controlled to ensure quality.
Continuous Process Verification: An approach where manufacturing performance is continuously monitored to ensure that the process remains in control.
Procedures for ensuring that product design meets the intended use and requirements.
The multidimensional combination of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality.
Design of Experiments: A statistical method used to determine the relationship between factors affecting a process and the output of that process.
Category: Statistical
Key Process Parameters: Parameters that have a critical impact on the production process and product quality and need to be tightly controlled.
Ongoing activities that ensure the continued performance of the product and process over time.
Material Attributes: Physical, chemical, biological, or microbiological properties of input materials that can affect process performance or product quality.
A statistical approach used to understand the relationships between multiple process parameters and quality attributes simultaneously.
Process Analytical Technology: Systems used for analyzing and controlling manufacturing through timely measurements.
Category: Analytical
Process Attributes: Variables within the manufacturing process that can influence product quality.
A measure of how well a process can produce products within specification limits.
The ability of a process to remain unaffected by small, uncontrollable variations in input materials or operating conditions.
Quality by Design: A systematic approach to pharmaceutical development that emphasizes understanding and controlling variability in manufacturing.
Quality Target Product Profile: A summary of the quality characteristics a drug product should achieve.
A systematic process for the assessment, control, communication, and review of risks to product quality across the lifecycle.
A set of interrelated or interacting elements that organizations use to direct and control how quality policies are implemented and achieved.
The continuous assessment of manufacturing process parameters and quality attributes during production.
Real Time Release: The ability to evaluate and ensure the quality of in-process and/or final product based on process data.
The systematic process of identifying and evaluating potential risks in the product lifecycle and manufacturing process.
The boundaries within which product attributes must remain to ensure quality.
A strategic document that defines the desired product attributes and is used to guide the development process.