GxP Engagement: Supplier Quality Engineering System Design
The Project.
Supplier Quality Engineering System Design
The Case.
Strategy and procedure implementation for US Supplier Quality to ensure efficient processes and the acquisition of high-quality materials.
The Solution.
Project Team Deployed:
- 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.
