[Sephiroth]

Originally Posted by jonbxx

The and EC and EMA wouldn't have knowledge of how easy or hard the tech transfer would be, they would work on information from the manufacturer. Some tech transfers are easy, some are not. I have seen issues where exactly the same equipment and chemicals are used at two sites and the results are different. Unexpected quirks pop up all the time but these are usually ironed out behind closed doors.

If AZ promised the tech transfer done by a certain time and manufacturing to start, to an extent, their word is taken on it as they would be the experts in their manufacturing process. Even the EMA would only be looking at how the production at site x, y or z is done in terms of quality and safety, not if it works at all.

The EC project delivery manager would have the knowledge of how to do a risk analysis. They did have a project manager, didn't they?