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.
Results like these start with a clear scope. Scope your project with i-Pharm GxP.
i-Pharm GxP's Project team provided exceptional remediation support to ensure a successful CAPA.
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