Articles
PQLI Definition Of Criticality
April 1, 2009
Click Here To Download:
•White Paper: PQLI Definition Of Criticality
•White Paper: PQLI Definition Of Criticality
•White Paper: PQLI Definition Of Criticality
By Roger Nosal and Tom Schultz
This paper describes progress made by the Criticality Task Team within the ISPE PQLI initiative. It aims to provide a concise, coherent, and universal approach for determining criticality for parameters, material attributes, conditions, and quality attributes. The work also clarifies the risk based distinctions governing the assignment of criticality to provide consistency and facilitate the adoption and implementation of Quality by Design (QbD) principles in the development of pharmaceutical manufacturing processes. The application of the concept of criticality presented in this paper aligns with the principles of ICH Q8, Q9 and Q10 guidelines.
Click Here To Download:•White Paper: PQLI Definition Of Criticality
