What are CQA & CPP for tablets and Capsules?

Question

Accepted Answer

CQA stands for Critical Quality Attributes and CPP stands for Critical Process Parameters for tablets and capsules.

CQA are the key physical, chemical, biological, or microbiological characteristics that must be within an appropriate limit, range, or distribution to ensure the desired product quality.
CPP are the key process parameters that should be controlled within a narrow range or set points to ensure the product meets the desired quality attributes.
Examples of CQA for tablets and capsules include potency, dissolution rate, uniformity of dosage units, and impurities.
Examples of CPP for tablets and capsules include mixing time, compression force, drying temperature, and coating thickness.

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