ISPE Good Practice Guide: Cold Chain Management
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2011
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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 Validation
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2019
ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 4 – Process Performance and Product Quality Monitoring System
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2012
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 Baseline Guide: Volume 3 – Sterile Product Manufacturing Facilities, Third Edition
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 04/01/2018
ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2013
GAMP Good Practice Guide: Electronic Data Archiving
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2007
ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 1 – Product Realization using QbD, Concepts and Principles
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2011