GxP Engagement: Supplier Quality Engineering System Design
The Project.
Supplier Quality Engineering System Design
![GxP Engagement: Supplier Quality Engineering System Design](https://sitescdn.wearevennture.co.uk/public/i-pharm/mediahub/supplier-quality-engineering-system-design-3a2673ccacef425588d1a08c4da68a04.png)
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
![](https://sitescdn.wearevennture.co.uk/public/i-pharm/mediahub/pharmaceauticals-ca64fc34c01641e48173331043cd08b5.png)
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.
![Quotation Marks](/img/Group774.png)
i-Pharm GxP's strong project work ensured a successful implementation of our first US product launch.