Publications Text Search By Year 20262025202420232022 Group Apic Group APIC GroupAPIC ManagementAPIC Task Force APIC Task Force APIC Cleaning ValidationAPIC Data Integrity TFAPIC GDP TFAPIC ICH Q7 – How-To-Do TFAPIC Nitrosamine TFAPIC Supplier Management TFICH Category Annual reportAuditBrochureFAQGuidanceLetterMeeting reportPosition papersReportTemplate Reset 10/07/2026 GDP for APIs: “How to do” Document Download 24/03/2026 Annual Report 2026 Download 02/03/2026 Template for report on Nitrosamine Risk Evaluation Update January 2026 – V4 Download 02/03/2026 Position Paper on the use of recycled solvents in production of APIs Download 11/12/2025 Quality Agreement Template for Regulatory Starting Materials (“RSMs”) and Critical Materials Download 03/12/2025 Annex 1 – Best practices guide for managing suppliers of API manufactures Download 15/10/2025 Data Integrity — Frequently Asked Questions (FAQ) Download 13/06/2025 Annual report 2024 Download 21/05/2025 Nitrosamine Risk Management: Guidance for API Manufacturers Download 21/01/2025 How to do – Interpretation of ICH Q7 Guide Download 14/01/2025 Data Integrity — Frequently Asked Questions (FAQ) Download 16/12/2024 Report on the risk of potential presence of Nitrosamines impurities Download 30/08/2024 APIC position on Nitrosamine Drug Substance Related Impurities (NDSRIs) and vulnerable amine impurities acceptable limits in APIs Download 01/08/2024 Letter of intent for collaboration between APIs manufacturers ans MAHs on Nitrosamines Drug Substance Download 16/04/2024 Annual Report 2023 Download 19/03/2024 Best practices guide for managing suppliers of API manufacturers Read more 13/02/2024 APIC Quality Agreement guideline & Template Read more 19/06/2023 APIC Position Paper on the Active Substance Master File Certificate Download 09/05/2023 M7 information to HA and MAH – Templates Read more 11/04/2023 Data Integrity – Frequently Asked Questions (FAQ) Download 25/01/2023 APIC Position Paper on the European Active Substance Master File (ASMF) Single Assessment Download 23/04/2022 Practical Risk-based Guide for Managing Data Integrity Read more 14/03/2022 How to do – Interpretation of ICH Q7 Guide Read more 15/02/2022 Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants Download
