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Definitions
Critical Quality Attributes (CQA)
– 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)
Critical Process Parameter (CPP)
– A process parameter whose variability has an impact on a
CQA and therefore should be monitored or controlled to
ensure the process produces the desired quality. (ICH Q8)
Critical Material Attribute (CMA)*
– A physical, chemical, biological or microbiological property
or characteristic of an input material that should be within
an appropriate limit, range, or distribution to ensure the
desired quality of output material.
*CMA is not defined in ICH guidance, but used here for discussion purposes