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Manufacturing Baseline TOP Requirements for Manufacturing / GMP Projects The following section documents the Manufacturing baseline TOP requirements for every Manufacturing/GMP project.

The Manufacturing/GMP project support staff requests that the General Contractor coordinate and deliver the Installation Verification (IV) documentation and incorporate it into the project turnover package.

Installation Verification information has been structured to follow the Validation Installation Qualification documentation format. Therefore it is not only used by Manufacturing team as the base for equipment data, but it is also used by the Validation team as one of the most important references in the process of commissioning and validating the facility or system.

The GC will be issued the Installation Verification Guideline Document early in the project, which gives the overview of the IV documentation and provides instructions on how to complete the required forms. Additionally, the GC should obtain electronic copies of the IV templates from Amgen.

The required Installation Verification documentation must be formatted using the Amgen Manufacturing predefined templates.

The GC should direct all questions and requests regarding the IV to the Amgen Project Engineer, who should provide guidance on completing this part of the documentation. The PE would also be responsible for verifying that the IV documentation has been completed correctly. The IV should be delivered in the two forms:

IV Binder

IV Electronic Media Set

Table 3: Manufacturing TOP Deliverables

  • Quantity: 2 or more, depending on requirements

  • Format:

    • Provide the Cover and Edge description, including Amgen project name and number and binder sequence number

    • Provide the content index per template

    • Incorporate tabs for sections

    • Collate

    • Provide covers large enough to accommodate the 8.5x11 or 11x17 size documents

  • Quantity: 2 or more, depending on requirements

  • Format:

    • Label on the CD box and face identifying the Amgen project name and number and the CD sequence number

    • Provide the electronic content index

    • Structure the CD electronic folder to resemble the binder structure

Turnover Package


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