GxP Engagement: Remediation of Aseptic Manufacturing Facilities.
The Project.
Remediation of Aseptic Manufacturing Facilities.
The Case.
Planning, leading and strategically working through closure/triage of Deviations and CAPAs in support of production.
Training, supporting, and mentoring junior team members in: Deviations investigation, CAPA/RCAUpskilling GMPCross-functional communication.
The Solution.
Project Team Deployed:
- 1 X PM
- 5 SME GMP Consultants
- 2 X Technical Writer
The Outcome.
Successful roll-out of Deviation Management Process and workflow training.
Successful reduction of backlog and restart of production operations.
Successful re-design and implementation of 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.
