Annual Audit Summary Report

This report provides a summary of the various audits conducted by the IRCA certified Lead Auditor from FWQRC – Global GxP & Regulatory Consultant in accordance with the following regulations across various industries in Asia and Europe during the past year:

1. ICH (Q7): Conducted audits to ensure compliance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7 guidelines.
2. EU-GMP- Part I: Audited medicinal products for human and veterinary use to ensure adherence to the EU-GMP Part I regulations.
3. EU-GMP- EudraLex: Ensured that active substances used as starting materials comply with the EudraLex Volume 4, Part-II-Basic Requirements.
4. EU-GMP-Part-IV: Conducted audits specific to Advanced Therapy Medicinal Products as per EU-GMP Part IV guidelines.
5. COFEPRIS – NORMA Official Mexicana NOM-164-SSA1-2015: Audited as per the Mexican health authority COFEPRIS’s official standard NOM-164-SSA1-2015.
6. Ministry of Food and Drug Safety Notice No.2021-87: Ensured compliance with the KFDA Regulation on Good Manufacturing Practices (GMP) for Medicinal Products.
7. USFDA 21 CFR PART 210: Conducted audits to ensure compliance with the USFDA’s Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs.
8. USFDA 21 CFR PART 211: Ensured adherence to the USFDA’s Current Good Manufacturing Practice for Finished Pharmaceuticals.
9. ISO 9001:2015: Audited for compliance with the ISO 9001:2015 Quality Management System.
10. ISO 14001:2015: Ensured adherence to the ISO 14001:2015 Environmental Management System.
11. ISO 45001:2018: Conducted audits as per the ISO 45001:2018 Occupational Health and Safety Management System.
12. ISO 14298:2021: Ensured compliance with the ISO 14298:2021 Graphic Technology – Management of security printing processes.
13. ISO 13485:2016: Audited for adherence to the ISO 13485:2016 requirements for a comprehensive quality management system for the design and manufacture of medical devices.
14. ISO 22000: Ensured compliance with the ISO 22000 Food Safety Management System.

FWQRC is committed to ensuring that organizations adhere to the highest standards of quality and regulatory compliance. We look forward to another year of helping organizations enhance their quality systems through rigorous audits.