GxP Engagement: Aseptic Process and Equipment Validation
The Project.
Aseptic Process and Equipment Validation
The Case.
Review validation impact assessments for new equipment/processes and changes to existing qualified systems and automation.
Review and approve verification and change control documentation supporting all changes to equipment, and new equipment.
The Solution.
Project Team Deployed:
- 3 x SME GMP Validation Consultants
- 1 x Project Manager
The Outcome.
Reviewed and approved validation protocols and reports.
Successful validation as an SME during customer and regulatory audits for all areas of responsibility.
Represented the unit as a customer interface on equipment installation teams to support all phases of validation.
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