This video is about CQAs | Critical Quality Attributes in Pharmaceuticals

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What are Critical Quality Attributes?



Critical Quality Attributes (CQA) are measurable properties of the product that are considered critical for establishing the intended purity, efficacy and safety of the product in conjunction with the process validation.


A quality attribute is a regulatory or compliance related characteristic that can be measured/tested and will form the basis for process qualification testing.




Quality Critical Attributes should be defined, justified, and documented for validation of all products.

A physical, chemical, biological, or microbiological property or characteristic that should
be within an appropriate limit, range, or distribution to ensure the desired
product quality (ICH Q8)




Examples of Critical Quality Attributes?




Physical Attributes,

Identification,


Assay,

Content
Uniformity,

Blend uniformity,

Dissolution And Drug Release,

Degradation Products,

Residual Solvents,

Moisture,

Microbial Limits, etc.

Tablet Thickness,

Tablet Hardness,

Tablet weight

Tablet thickness

friability





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