The Manufacturing TOP documentation requirements should not, in any way, replace or supersede documentation required by Engineering.
The Validation Installation section of the Turnover package must be delivered to Amgen together with the rest of the project turnover package.
Archiving of the Project Documentation At project closure, one complete set of the project documentation including the Active Engineering File and the Turnover Documentation should be archived. The additional TOP set(s) should be distributed to internal users based on their requests.
The project documentation should be archived in accordance to the site engineering archiving standards.
Retention It is recommended that the Project Coordinator requests the retention dates for all the project documentation. Most of the documents lose their validity over a period of time and should be purged accordingly based on Amgen global retention guidelines.
The Amgen global corporate retention team is currently working on defining the guidelines for the retention of project records. They will be referenced in this document once it becomes available.
Off-Site Storage If the on-site storage space is inadequate, it is recommended that the Project Coordinators contact an off-site storage vendor. The Thousand Oaks office recommends contacting the national Iron Mountain Storage Company as the preferred Amgen off-site storage vendor.