cGMP Qualification
Project: 070028 Clean Utilities Re-qualification
Building Type: Oral Solid Dosage Manufacturing Plant
General Project Description: Griffin Engineering provided the project with qualification services to support the changes being made to the site Clean Steam, Water for Injection, and USP Water Systems. System changes involved mechanical upgrades, instrumentation, and control and monitoring changes. Although the automation and equipment commissioning was performed by other contractors, Griffin reviewed all commissioning documents to ensure the test cases would be acceptable for validation activities. Leveraging (referencing, not repeating) of commissioning testing during qualification saves the project time and money.
Services Provided:
- Review of Commissioning Documents
- Development of the Automation and Equipment IOQs
- Post-review and Approval of all Commissioning Documents
- Execution of the Re-qualification
- Draft Summary Reports and Close out of the Validation Documents
Special Challenges:
- The work was performed under a compressed holiday shut down schedule.
- The project scope of work changed through the early stages of construction.