ISPE Good Practice Guide: Management Engineering Standards
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2016
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
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: Assessing the Particulate Containment Performance of Pharmaceutical Equipment
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2012
ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 06/01/2017
GAMP Good Practice Guide: Data Integrity – Manufacturing Records
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2019
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
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
ISPE Baseline Guide: Volume 1 – Active Pharmaceutical Ingredients (Second Edition)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 06/01/2007
ISPE Good Practice Guide: Process Validation
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2019