Category: ISPE
ISPE

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

Good Practice Guide: Investigational Medicinal Product Reverse Logistics
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/21/2021

ISPE Good Practice Guide: Good Engineering Practice, Second Edition
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 10/01/2021

Good Practice Guide: Enabling Innovation
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/01/2021