• Product Quality Lifecycle Implementation Guide: Product Realization
    Full Title: ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 1 – Product Realization using Quality by Design (QbD): Concepts and Principles, including Overview, Criticality, Design Space, and Control Strategy
    Pages: 188
    Published: 2011-11-01
  • Good Practice Guide: Process Validation
    Full Title: ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation
    Pages: 208
    Published: 2019-03-01