Publications Text Search By Year 2024(2)2023(4)2022(3)2021(2)2020(1)2019(2)2018(2)2017(2)2016(1)2015(1)2014(2)2012(2)2008(1)2005(1)2002(1) Reset 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 09/05/2023 M7 information to HA and MAH – Templates Read more 11/04/2023 Data Integrity – Frequently Asked Questions (FAQ) 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 17/06/2021 The APIC Audit Program Read more 23/03/2020 Nitrosamines Read more 31/10/2019 Supplier Management Read more 23/03/2019 GDP Read more 23/11/2018 Guideline Technical Change Control revised Download 23/10/2018 Audits of RSM Suppliers Read more 23/10/2017 APIC Brochure Download 23/10/2016 APIC Auditing Guide Read more 23/06/2015 Guidance on Handling of Insoluble Matters and Foreign Particles in APIs Download 23/10/2014 Qualification of existing equipment Download 23/07/2014 eCTD How to do Document Download 23/10/2012 APIC Quick Guide for API Sourcing Download 23/10/2012 Guideline for Qualification & Management of Contract Quality Control Laboratories Download 23/10/2012 Quality Agreement for Laboratories Download 23/10/2005 Quality Management System (QMS) for APIs Download 23/10/2002 Computer Validation Guide Download
