The transfer of a new ATMP production line

Our consultant Dennis has worked on a large technology transfer project to move a new ATMP production process from the US to the Netherlands. One of the subprojects was to get the complete set of GMP documentation (230 documents) ready for production on time.

The main challenge was that the documents had to be reviewed by nine different departments. Moreover, virtually every document had an electronic draft version, review round, review annotation round, pre-approval round and final approval round. To manage this process in a structured way, we used the document management system Gvault. In order to make all these changes, six technical writers worked on the majority of the 230 documents to draft and finalize the documents after review rounds. In addition to these six project team member, 30 others were involved in the project as writer, author or approver on the remaining documents.

We are proud to say that for the first phase all milestones were achieved on time and the first batch of the transferred process has been produced. Working in such a large team required intensive communication and coordination, during a time when many of us had to work from home. 

Discover more about ATMPs at the Dutch ATMP Summit.