GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (German Version)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2008
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ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/01/2009
ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2012
ISPE Good Practice Guide: Quality Laboratory Facilities
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/01/2012
ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 2 – Product Realization using QbD, Illustrative Example
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2011
ISPE Good Practice Guide: Booklet Labels
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 03/01/2013
ISPE Good Practice Guide: Management Engineering Standards
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2016
ISPE Good Practice Guide: Maintenance
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2009
ISPE Good Practice Guide: Single-Use Technology
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2018
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