GxP Engagement: Supplier Quality Engineering System Design

The Project.

Supplier Quality Engineering System Design


GxP Engagement: 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.


Quotation Marks
i-Pharm GxP's strong project work ensured a successful implementation of our first US product launch.
Large Pharmaceutical Company