GxP Engagement: Aseptic Process and Equipment Validation
The Project.
Aseptic Process and Equipment Validation
![GxP Engagement: Aseptic Process and Equipment Validation](https://sitescdn.wearevennture.co.uk/public/i-pharm/mediahub/aseptic-process-and-equipment-validation-106605fcefa545e8aa3a15bdcb4c517d.png)
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
![](https://sitescdn.wearevennture.co.uk/public/i-pharm/mediahub/pharmaceauticals-cc8c6a227e894cebbcfddc0eb1bd0889.png)
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.
![Quotation Marks](/img/Group774.png)