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
ISPE Good Practice Guide: Process Validation
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2019
GAMP Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2010
ISPE Baseline Guide: Volume 2 – Oral Solid Dosage Forms
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2016
ISPE Good Practice Guide: Cold Chain Management
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2011
GAMP Good Practice Guide: Electronic Data Archiving
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2007
ISPE Good Practice Guide: Interactive Response Technology
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2011
GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2011
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 GAMP Guide: Records and Data Integrity
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 03/01/2017
ISPE GAMP RDI Good Practice Guide: Data Integrity – Key Concepts
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 10/01/2018
ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 06/01/2017