Cqa and cpp and their range for different stages in oral manufacturing.

Question

Accepted Answer

Cqa and cpp are critical quality attributes and critical process parameters respectively used in oral manufacturing.

Cqa refers to the physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.
Cpp refers to the process parameter that must be maintained within a narrow range to ensure the desired product quality.
The range for Cqa and Cpp varies depending on the stage of oral manufacturing, such as formulation, granulation, compression, coating, and packaging.
For example, in the formulation stage, Cqa may include particle size, bulk density, and flowability, while Cpp may include mixing time, mixing speed, and temperature.
In the compression stage, Cqa may include tablet hardness, friability, and disintegration time, while Cpp may include compression force, dwell time, and tablet weight.
In the packaging stage, Cqa may include moisture content, seal integrity, and label accuracy, while Cpp may include sealing temperature, sealing time, and label placement.

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