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NOTICE: We are performing maintenance on the ISPE Guidance Documents Portal on Tuesday 14 May. Current users can access their existing content, however, new purchases cannot be made. We apologize for any inconvenience this may cause.
Published: November 2011
Pages: 188
Product Realization using QbD: Concepts and Principles (PQLI® Guide 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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