Global Sterile Manufacturing Regulatory Guidance Comparison & Assessment Tool Second Edition
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Companies producing sterile drug products must remain compliant with all regulations and requirements for current good manufacturing practices (cGMP) for any country or region where they wish to manufacture and market their products. Each regulatory authority presents their requirements through differing approaches, covering topics between multiple reference sources that have different enforcement requirements (e.g., law, regulation, directive, pharmacopeia requirement, or guidance). One of the challenges to the drug industry is tracking all the published requirements and staying current in their interpretation by regulatory bodies.
This publication compares seven regulatory documents and identifies similarities and differences between them. This analysis and the accompanying Excel file tool, which provides a detailed, line-by-line comparison of all seven guidelines on aseptic processing, will enable the reader to:
- Prepare for Health Authority inspections
- Educate new and experienced staff
- Guide internal assessment of sterile manufacturing facilities, equipment, procedures, and personnel
- Perform gap assessment against global aseptic processing requirements
- Assist decision-making for investments
The following documents were compared and are presented in the Excel file:
- Guidance for Industry. Sterile Drug Products Produced By Aseptic Processing – Current Good Manufacturing Practice. U.S. Food and Drug Administration. 2004.
- The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. Annex-1 European Commission. 2022.
- TRS 1044 - Annex 2: WHO good manufacturing practices for sterile pharmaceutical products. 31 October 2022. World Health Organization.
- PE 009-17 (Part 1) Guide To Good Manufacturing Practice For Medicinal Products – Part 1. 25 August 2023 Pharmaceutical Inspection Co-Operation Scheme.
- Annex 1 to the good manufacturing practices guide – Manufacture of sterile drugs February 28, 2018. Health Canada.
- Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing Pharmaceuticals and Medical Devices Agency (Japan).
- Good Manufacturing Practice for Drugs (2010 Revision) Annex 1, Sterile Medicinal Products. (Chinese GMP).
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