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5.0

Turnover Package........................................................5

    • 5.1

      TOP Process............................................................................5

    • 5.2

      Active Engineering File vs. Turnover Package .................................5-1

    • 5.3

      Amgen TOP Requirements ........................................................5-2

      • 5.3.1

        Engineering Baseline TOP Requirements ..............................5-2 Binder Sets Composition...................................................5-4 Drawing Sets Composition.................................................5-5 Electronic Media CD Sets ..................................................5-5

      • 5.3.2

        Manufacturing Baseline TOP Requirements for Manufacturing/GMP Projects .............................................5-7

      • 5.3.3

        Archiving of the Project Documentation ................................5-9 Retention .....................................................................5-9 Off-Site Storage .............................................................5-9

6.0

Glossary...................................................................6

Appendix

A:

Appendix

B:

Appendix

C:

Appendix

D:

Appendix

E:

Appendix

F:

Appendix

G:

Appendix

Project Team Participants..............................................A-1 Sample Administrative Folders Setup and Structure ..............B-1 Sample Engineering Folders Setup and Structure .................C-1 Livelink Endeavor .......................................................D-1 Prolog......................................................................E-1 Microsoft Outlook........................................................F-1 Sample Turnover Binder Structure ...................................G-1

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