GxP Engagement: Remediation Support at Aseptic Fill-Finish Facility
The Project.
Remediation Support at Aseptic fill-finish facility.
The Scope.
i-Pharm GxP was engaged under a defined Scope of Work to address a backlog of deviations, identify root causes, and support successful CAPA implementation at an aseptic fill-finish facility.
The Solution.
To execute the agreed Scope of Work, i-Pharm GxP deployed a dedicated project team:
• 10 x SME Investigators
• 2 x Lead Consultants
• 1 x Project Manager
The Outcome.
All critical and historical deviations were resolved and the backlog was reduced. We also delivered QMS improvement, training, and knowledge transfer to help prevent reoccurrence.
i-Pharm GxP's Project team provided exceptional remediation support to ensure a successful CAPA.
