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 6 – Biopharmaceutical Manufacturing Facilities
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2013
ISPE Good Practice Guide: Critical Utilities GMP Compliance
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 06/01/2020
GAMP Good Practice Guide: Data Integrity – Manufacturing Records
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2019
ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2007
ISPE Baseline Guide: Volume 5 – Commissioning and Qualification, 2nd Edition
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 06/01/2019
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 Good Practice Guide: Technology Transfer
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2014
GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 10/01/2012
ISPE Baseline Guide: Volume 4 – Water and Steam Systems, Third Edition
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/01/2019
ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2012
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