Process Characterization is a late stage process design activity which aims to develop in-depth process understanding so that effective and robust control strategies can be developed for production. It is an important milestone in manufacturing development. 

Activities include:

Use of risk assessment and analysis tools to prioritize experimental efforts.

Utilize advanced statistical experimental designs (DoE) including factorial and response surfaces to elucidate primary effects and interactions of potential CPP's and CQA's.

Employ statistical regression and mathematical modeling to develop process and product design space in line with Quality by Design (QbD) principles.

Analytical Method qualification and validation for process and product analysis using Analytical Development and Quality Control Departments.