PDF Standards ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2007
Blog Archive
PDF Standards ISPE Guide: Biopharmaceutical Process Development and Manufacturing
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 10/31/2013
PDF Standards 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
PDF Standards APQ Guide: Change Management (CM) System
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2022
PDF Standards ISPE GAMP Good Practice Guide: Computerized GCP Systems & Data
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2017
PDF Standards ISPE Sustainability Handbook
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2015
PDF Standards ISPE Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 04/01/2022
PDF Standards ISPE Good Practice Guide: Operations Management
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2016
PDF Standards 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
PDF Standards 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