St ISPE

St ISPE Guide - 503B Compounding - Regulatory basis and industry good practices for outsourcing facilities 2023

Standard St ISPE Guide - 503B Compounding - Regulatory basis and industry good practices for outsourcing facilities 2023 original PDF full version. Additional info and preview on request

Document status: Active

€35
St ISPE Drug Shortages Prevention Model 2023

Standard St ISPE Drug Shortages Prevention Model 2023 original PDF full version. Additional info and preview on request

Document status: Active

€35
St ISPE Baseline Guide volume 6 - Biopharmaceutical Manufacturing Facilities 2023

Standard St ISPE Baseline Guide volume 6 - Biopharmaceutical Manufacturing Facilities 2023 original PDF full version. Additional info and preview on request

Document status: Active

€35
St ISPE Guide - Advanced Therapy Medicinal Products - Recombinant AAV Comparability and Lifecycle Management 2023

Standard St ISPE Guide - Advanced Therapy Medicinal Products - Recombinant AAV Comparability and Lifecycle Management 2023 original PDF full version. Additional info and preview on request

Document status: Active

€35
St ISPE Good Practice Guide - Process Gases 2023

Standard St ISPE Good Practice Guide - Process Gases 2023 original PDF full version. Additional info and preview on request

Document status: Active

€35
St ISPE Baseline Guide - Pharma 4.0 2023

Standard St ISPE Baseline Guide - Pharma 4.0 2023 original PDF full version. Additional info and preview on request

Document status: Active

€35
St ISPE Report on ISPE work to support establishment of the EU Health Emergency Preparedness and Response Authority (HERA) 2023

Standard St ISPE Report on ISPE work to support establishment of the EU Health Emergency Preparedness and Response Authority (HERA) 2023 original PDF full version. Additional info and preview on request

Document status: Active

€35
St ISPE GAMP 5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems 2022

Standard St ISPE GAMP 5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems 2022 original PDF full version. Additional info and preview on request

Document status: Active

€35
St ISPE APQ Guide Series - Process Performance and Product Quality Monitoring System 2022

Standard St ISPE APQ Guide Series - Process Performance and Product Quality Monitoring System 2022 original PDF full version. Additional info and preview on request

Document status: Active

€35
St ISPE APQ Guide - Cultural Excellence 2022

Standard St ISPE APQ Guide - Cultural Excellence 2022 original PDF full version. Additional info and preview on request

Document status: Active

€35
St ISPE Good Practice Guide - Continuous Manufacturing of Oral Solid Dosage Forms 2022

Standard St ISPE Good Practice Guide - Continuous Manufacturing of Oral Solid Dosage Forms 2022 original PDF full version. Additional info and preview on request

Document status: Active

€35