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

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Cultural Excellence Report

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 04/01/2017

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APQ Guide: Cultural Excellence

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2022

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ISPE Good Practice Guide: Containment for Potent Compounds

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2022

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APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/22/2022

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ISPE Good Practice Guide: Membrane-Based Water Injection Systems

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/25/2022

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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

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APQ Guide: Change Management (CM) System

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2022

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ISPE Guide: ATMPs – Autologous Cell Therapy

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2021

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ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification Mapping and Monitoring

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2021

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