GxP Engagement: Remediation of Aseptic Manufacturing Facilities.
The Project.
Remediation of Aseptic Manufacturing Facilities.
The Scope.
i-Pharm GxP was engaged under a defined Scope of Work to plan, lead, and strategically manage the closure and triage of deviations and CAPAs in support of production.
The agreed scope also included training, supporting, and mentoring junior team members in deviation investigation, CAPA and root cause analysis, GMP upskilling, and cross-functional communication.
The Solution.
To execute the agreed Scope of Work, i-Pharm GxP deployed a dedicated project team:
• 1 x Project Manager
• 5 x SME GMP Consultants
• 2 x Technical Writers
The Outcome.
- Successful roll-out of the deviation management process and workflow training.
- Successful reduction of backlog and restart of production operations.
- Successful redesign and implementation of the QMS.
i-Pharm GxP deployed a team that ensured the successful roll-out of the Deviation Management Process, reduced the backlog and enabled production to restart.
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