GxP Engagement: CMO Inspection Readiness
The Project.
CMO Inspection Readiness
The Scope.
i-Pharm GxP was engaged under a defined Scope of Work to represent the Owner on-site at a CMO, ensuring compliant manufacture of the product and a robust QMS in preparation for inspection.
The Solution.
To execute the agreed Scope of Work, i-Pharm GxP deployed a dedicated project team:
• 1 x Project Manager
• 4 x SME Consultants
The Outcome.
A successful gap analysis led to a prioritised action plan focused on lab events, deviation management, and workflow.
i-Pharm GxP's team ensured ensured we had the robust processes in place required for a successful inspection.
