GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 10/01/2012
ISPE Baseline Guide: Volume 4 – Water and Steam Systems, Third Edition
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/01/2019
ISPE GAMP Guide: Records and Data Integrity
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 03/01/2017
ISPE Good Practice Guide: Clinical Supply Systems
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 03/01/2014
ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/01/2009
ISPE Baseline Guide: Volume 7 – Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2017
ISPE Baseline Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2013
ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2008
GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2012
ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 4 – Process Performance and Product Quality Monitoring System
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2012