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