Category: ISPE
ISPE
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: Process Gases
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2011
ISPE Baseline Guide: Volume 7 – Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2017
ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2017
GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2011
ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2011
ISPE Good Practice Guide: Technology Transfer
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2018
ISPE Good Practice Guide: Management Engineering Standards
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2016
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 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
ISPE GAMP Good Practice Guide: Global Information Systems Control and Compliance (Second Edition)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2017
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