GxP Engagement: Remediation Support at Aseptic Fill-Finish Facility
The Project.
Remediation Support at Aseptic fill-finish facility.
The Case.
Address backlog of deviations, identify the root cause and ensure successful CAPA.
The Solution.
Project Team Deployed:
- 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 provided QMS improvement, training and knowledge transfer to prevent re-occurrence.
i-Pharm GxP's Project team provided exceptional remediation support to ensure a successful CAPA.
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