Module 9 2021

19/03/2021

Definitions

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.

Input Materials Process Control Product Output

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 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)

*CMA is not defined in ICH guidance, the definition here is widely quoted by regulatory agencies

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Target Product Profile (TPP)

The quality target product profile (QTPP) describes the design criteria for the product, and should therefore form the basis for development of the CQAs, CPPs, and control strategy ICH Q9 states: “…the protection of the patient by managing the risk to quality should be considered of prime importance.” The QTPP provides an understanding of what will ensure the quality, safety, and efficacy of a specific product for the patient and is a starting point for identifying the CQAs”

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