ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System ISPE
GAMP Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach ISPE
ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 4 – Process Performance and Product Quality Monitoring System ISPE