Differences between FDA and Annex 1 (Draft) EU GMP on Clean Room Classification

EU GMP regulations for clean rooms:

1. airborne particles with sizes ≥ 5.0 μm are differently counted and proposed between these two regulations.

2. FDA and EU GMP have different proposals on terminally sterilized and aseptically filled. products regarding Clean Rooms and Entering process.

3. Annex 1 has different view of start up, testing and monitoring after initial certification

4. Safety dangers from interlocking systems.

5. Cascade flow in personnel entrance through different Grade rooms are historically connected to deferential reading of both regulations.

6. Is micro contamination really measured in both regulations the same way and on a logical ground?

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