ISPE GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems – A Companion Volume to GAMP 5
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2010
ISPE Good Practice Guide: Quality Laboratory Facilities
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/01/2012
ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2011
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 Sustainability Handbook
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2015
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 Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2016
ISPE Good Practice Guide: Process Gases
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2011
ISPE GAMP Good Practice Guide: A Risk-Based Approach to Regulated Mobile Applications
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 10/01/2014