PQLI Definition of Criticality |
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| Authors: | Roger Nosal Tom Schultz |
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| Institution: | (1) Pfizer Inc., Eastern Point Rd., Groton, CT 06340, USA;(2) Johnson & Johnson, 1125 Trenton-Harbourton Rd., Titusville, NJ 08560, USA |
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| Abstract: | 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.
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| Keywords: | PQLI Design space Criticality Control strategy Critical quality attribute Critical process parameter Knowledge space Target product profile Product and process knowledge Quality by design Quality risk management |
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