Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2011
Category: ISPE
ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2008
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 Good Practice Guide: Process Gases
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2011
ISPE Good Practice Guide: Technology Transfer
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2014
ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2017
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: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2014
ISPE Baseline Guide: Volume 2 – Oral Solid Dosage Forms
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2016
GAMP Good Practice Guide: Data Integrity – Manufacturing Records
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2019