GxP Engagement: Aseptic Process and Equipment Validation
The Project.
Aseptic Process and Equipment Validation
The Scope.
i-Pharm GxP was engaged under a defined Scope of Work to review validation impact assessments for new equipment and processes, as well as changes to existing qualified systems and automation.
The agreed scope also included review and approval of verification and change control documentation supporting changes to existing equipment and the introduction of new equipment.
The Solution.
To execute the agreed Scope of Work, i-Pharm GxP deployed a dedicated project team:
• 3 x SME GMP Validation Consultants
• 1 x Project Manager
The Outcome.
- Reviewed and approved validation protocols and reports.
- Provided successful validation support as an SME during customer and regulatory audits across all areas of responsibility.
- Acted as the customer interface within equipment installation teams to support all phases of validation.
i-Pharm GxP’s team provided the expertise and oversight needed to ensure successful validation across our equipment and processes.
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