Category: ISPE
ISPE
ISPE Readiness Report Bundle
Report on ISPE Work to Support Establishment of the European Union Health Emergency Preparedness and Response Authority (HERA) and Increasing Domestic Resiliency in the Supply of Essential Active Pharmaceutical Ingredients
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2023
APQ Guide: Cultural Excellence
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2022
ISPE Good Practice Guide: Containment for Potent Compounds
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2022
APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/22/2022
ISPE Good Practice Guide: Membrane-Based Water Injection Systems
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/25/2022
ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems, Second Edition
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/31/2022
ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification Mapping and Monitoring
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2021
ISPE Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 04/01/2022
APQ Guide: Change Management (CM) System
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2022
ISPE Guide: ATMPs – Autologous Cell Therapy
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2021
Good Practice Guide: Knowledge Management in the Pharmaceutical Industry
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 04/30/2021
APQ Guide: Management Responsibilities & Review (MRR)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2021