Design & Quality Consulting Services for Insulin Project

Project Background：

The client is one of the well-known global pharmaceutical enterprises, leveraging its profound expertise in the pharmaceutical field to provide innovative treatment solutions for patients worldwide, particularly excelling in areas such as cardiovascular diseases, oncology, diabetes, and central nervous system disorders. While the insulin market is relatively mature overseas, the continued increase in the global aging population and the number of diabetes patients indicates ongoing growth in this niche sector. It is forecasted that by 2030, the domestic market capacity will also reach several hundred billion RMB. A compliant quality management system is fundamental in ensuring patient safety and health, and it also embodies the company's social value.

Project Info.：

• Project name：Insulin aseptic filling production line project

• Product type：Insulin

• Facility type：Expansion project

• Project-driven：Compliance with international regulations, Quality Safety, Rapidity

Service Scope：

• Project design & quality management

• Development of C&Q validation strategies

• Risk analysis and DQ for facility systems

• Risk analysis and DQ for process equipment

• Guidance and review of validation for factory facility systems and process equipment

• C&Q Compliance according to ISPE Guideline

Project Challenges：

• Risk analysis for multiple products manufacture in shared facilities

• Compliance with the latest version of EU Annex 1

• Simplification of personnel configuration and diversification of facility systems

Our Capabilities：

• Project experience with NMPA, EMA, and FDA standards

• Compliance monitoring throughout project execution

• Capability enhancement for client's project team

• Application of the new version of ISPE C&Q guidelines