Category: ISPE
ISPE
Posted in ISPE
ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2008
Posted in ISPE
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
Posted in ISPE
ISPE Good Practice Guide: Operations Management
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2016
Posted in ISPE
ISPE Baseline Guide: Volume 5 – Commissioning and Qualification, 2nd Edition
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 06/01/2019
Posted in ISPE
ISPE Guide: Biopharmaceutical Process Development and Manufacturing
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 10/31/2013
Posted in ISPE
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
Posted in ISPE
ISPE GAMP RDI Good Practice Guide: Data Integrity – Key Concepts
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 10/01/2018
Posted in ISPE
ISPE Baseline Guide: Volume 2 – Oral Solid Dosage Forms
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2016