GxP Engagement: Supplier Quality Engineering System Design
The Project.
Supplier Quality Engineering System Design
The Scope.
i-Pharm GxP was engaged under a defined Scope of Work to support strategy and procedure implementation for US Supplier Quality, ensuring efficient processes and the acquisition of high-quality materials.
The Solution.
To execute the agreed Scope of Work, i-Pharm GxP deployed a dedicated project team:
• 1 x Project Manager
• 2 x SME Consultants
The Outcome.
- Writing of processes, procedures and SOPs to define the function on behalf of the US business.
- Development of international partners and subsequent evaluation of performance data & CAPA implementation.
- Per supplier assessment for QMS including processes, documentation, training, records and process qualification.
- Acting and functioning in-house Quality representatives for documentation, design reviews and ongoing risk assessments.
- Timely generation of Design History File (DHF) for hardware and software.
- Successful implementation in support of the first US product launch.
i-Pharm GxP's strong project work ensured a successful implementation of our first US product launch.
