PDF Standards GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2005
Blog Archive
PDF Standards ISPE Baseline Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2013
PDF Standards APQ Guide: Management Responsibilities & Review (MRR)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2021
PDF Standards GAMP Good Practice Guide: Data Integrity – Manufacturing Records
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2019
PDF Standards ISPE Good Practice Guide: Equipment Reliability
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2020
PDF Standards ISPE Good Practice Guide: Management Engineering Standards
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2016
PDF Standards APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/22/2022
PDF Standards ISPE Good Practice Guide: Process Gases
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2011
PDF Standards 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
PDF Standards GAMP Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2010