Category: ISPE
ISPE
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: Technology Transfer
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2014
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 Baseline Guide: Volume 3 – Sterile Product Manufacturing Facilities, Third Edition
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 04/01/2018
ISPE Baseline Guide: Volume 1 – Active Pharmaceutical Ingredients (Second Edition)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 06/01/2007
GAMP Good Practice Guide: Electronic Data Archiving
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2007
ISPE GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems – A Companion Volume to GAMP 5
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2010
ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2012
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 Good Practice Guide: HVAC and Process Equipment Air Filters
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2019
ISPE Good Practice Guide: Asset Management
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2019
ISPE Good Practice Guide: Comparator Management
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 03/01/2012