dealtn wrote:How are AZN blamed if it's the sub-contractor responsible (I haven't read the link)?
When it comes to pharmaceutical manufacturing, the 'regulated company' is responsible for the whole process, even if they sub-contract anything out.
I just did further training on the various US/EU laboratory and manufacturing regulations a few weeks ago as part of my employment; as a subcontractor company all we can do is support the regulated pharmaceutical companies in meeting the regulations; we aren't able to claim our products or services are 'compliant' with the regulations, because it all depends how the regulated companies use what we provide.
Only the regulated company can ensure compliance because it all depends on how the whole process fits together, and only the regulated company has the overall oversight.
I would presume (though the training I undertook was only looking at the technical implications, so didn't cover this aspect), that the 'regulated company' will be the one applying for the licence, etc. For the AZ vaccine, I'd guess this would be AstraZeneca (though I don't know for sure), simply because I doubt each manufacturing subcontractor will go about separately getting licenced, though I don't know any of the details at that level of applying for licences, etc.
Happy to stand corrected if others know more definite details - specifically in this case whether AZ is considered the 'regulated company', or the 'sub-contractor' is considered the 'regulated company', but it was definitely a main take away from our training that the 'regulated company' is ultimately responsible, and they can't pass the book to subcontractors (and vice versa, the subcontractor / supplier cannot claim 'compliance' for their products in isolation). The 'regulated company' are responsible for all validation tests, etc, etc, to ensure that anything provided by subcontractors meets necessary safety and any other standards, etc.
I've just found these FDA guidelines for Covid-19 vaccine licencing
https://www.fda.gov/media/139638/download , and there doesn't seem to be any clear separation between vaccine development vs. manufacture, so it would seem the whole vaccine development process will likely form part of any licence. So this further leads me to think that AZ will probably be considered the 'regulated company'.