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Figure 6: Phase III – Project Turnover and Closure

Project Design, Construction, Start-Up, and Commissioning. See Phase II

Start Phase III

TOP and Closure

Develop the TOP Matrix:

  • Reconfirm the TOP Scope with A/E, GC and PM

  • Develop and Distribute the Schedule for the Delivery

of the TOP Documents

Manufacturing or GMP Project?

Satellite Involvement

No

Manage the Transfer of the TOP Package from the GC:

  • Verify the Completeness of the Package

  • Notify the Amgen Team about the TOP Delivery and Request Their Assistance in its Review

Develop Document Retention Matrix for the Project:

  • Use the Master Retention Policy guidelines as Template

  • Re-verify Correctness and Completeness of the final Docs with the PM and Supervisor

Project Support Internal Activity Amgen Internal Activity A/E & GC Related Activity Start or End of Flow Flow Connection Point

Archive all of the Project Data and Files:

  • Electronically Archive the Project Database

  • Electronically Archive all the E- mails and Computer Files

  • Archive the Hard Copy Documents at Offsite Storage

Initiate and Execute the Project Closure:

  • Notify the PS Supervisor that the Project is about to be Closed

  • PS Supervisor will Spot-Check the Completeness of Archive

  • PS Supervisor will Authorize the Release of the Project Closeout Signoff Form

  • DC will Manage the Routing of the Form and File with the Project Files

End Phase III

Process Overview

Yes

Manage the Transfer of the TOP Package from the GC:

  • Verify the Completeness of the Package

  • Notify the Amgen Team about the TOP Delivery and request their assistance in its review

  • Coordinate the review process of the manufacturing, validation, and

maintenance/operations portion of the TOP

Develop Document Retention Matrix for the Project:

  • Use the Master Retention Policy guidelines as Template

  • Re-Verify Correctness and Completeness of the final Docs with the PM and Supervisor

Manage the Transfer of the TOP Package to Manufacturing, Validation, and Maintenance/Operations

3-5

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