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.
Document identifier
ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 1 - Product Realization using QbD, Concepts and Principles
ISPE Category
PQLI Guides
Publication date
2011-11-01
International Relationship
Price |
460 vnd |