ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement
Part 1 – Product Realization using QbD, Concepts and Principles

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Published: November 2011
Pages: 188
Table of Contents ( 519 KB)

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Part 1 includes the topics of Criticality, Design Space, and Control Strategy and addresses product and process development, transfer to, and establishment of, commercial manufacture using science- and risk-based approaches.

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