What was your role in the project?
Thomas: I was part of the project team as the QA lead. In this role, I was involved in discussions about how we would design the system, right through to the final documentation of this approach in procedures and work instructions.
Sofie: I served as Technical Writer, providing support in delivering the necessary documentation and conducting theoretical and practical training for end users.
What were the main challenges?
Thomas: Since this is a multi-use facility, both experimental and clinical batches can be manufactured there. The biggest challenge for us as the QA department was to maintain a balance between the flexibility required for experimental batches and the level of compliance required for clinical batches. That’s why we conducted an end-to-end risk analysis of the clinical batch manufacturing process within the system to ensure that all compliance requirements were defined and addressed in a structured manner.
Sofie: With regard to documentation, I think the biggest challenge in the initial phase was motivating and guiding all authors to invest time in getting to know the system, discussing concepts with other stakeholders, and starting to draft all procedures. As with all new things, the beginning is always the hardest. In the next stage, we organized joint review sessions so that all comments could be addressed immediately with the entire team.
What did you learn during the project?
Thomas: One of the great opportunities I had during this project was attending a training session provided by the MES system vendor. During this training, I was able to learn a lot about the system and how the software works.
Sofie: I gained a lot of knowledge about the software itself and its practical application in a dynamic context where we must comply with clinical regulations while still remaining flexible for development work at the plant.
In the meantime, the first clinical batches have been produced using an electronic batch record. Kudos for the great collaboration with the Janssen project team.
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