When/how to switch from RUO to GMP Materials
In the early stages of development, organizations may use Research use only (RUO) materials. This is particularly prevalent in the ATMP field where often suppliers are small scale and supplier base less mature. However, as organizations progress to clinical trials, it will be important to ensure materials of GMP standard are utilized.
Lack of clarity
Currently there is a lack of understand and confusion around the process of what is required for RUO upgrade of materials. There is also a lack of clarity of when this upgrade is required.
Reduced regulatory risk
This team will provide a risk assessment tool to support the switch from RUO to GMP. In developing this risk assessment tool, the team will discuss what would health authorities want to know about the materials, release criteria, are quality attributes met and is the material safe for use. It is hoped this deliverable will result in reduced risk of regulatory delay and reduced time to market.
When/how to switch from RUO to GMP Materials deliverables
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