What is critical process parameter? : Pharmaceutical Guidelines

What is critical process parameter?

Interview Question #043 - What is critical process parameter?
A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.
Or
A process condition or material or a test when it is essential to maintain a predetermined rage in order to reproducibly meet the specification is called a critical parameter. Critical parameters have a direct impact on the quality of a product.



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