Global Sterile Manufacturing Regulatory Guidance Comparison & Assessment Tool Second Edition

**PRE-SALE! Full title will be released on 10/2/24**

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:

1. Prepare for Health Authority inspections

2. Educate new and experienced staff

3. Guide internal assessment of sterile manufacturing facilities, equipment, procedures, and personnel

4. Perform gap assessment against global aseptic processing requirements

5. Assist decision-making for investments