ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2008
ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2012
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
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2012
ISPE Good Practice Guide: Process Gases
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2011
ISPE Good Practice Guide: HVAC and Process Equipment Air Filters
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2019
GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, Second Edition
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2010
Comprehensive Guide to Clinical Materials: A Handbook for Training Clinical Materials Professionals
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2006
ISPE Good Practice Guide: Maintenance
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2009
ISPE Good Practice Guide: Management Engineering Standards
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2016
ISPE Baseline Guide: Volume 5 – Commissioning and Qualification, 2nd Edition
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 06/01/2019