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newman2021

03/27/23 8:33 PM

#580934 RE: flipper44 #580932

what is a GMPC? Looks like FW/EDEN reproducibility involved in this QA/QC. Am I correct, flipper?

Doc logic

03/27/23 8:35 PM

#580935 RE: flipper44 #580932

flipper44,

Someone noted a type of change in the notification but no mention of GMPC that I know of. Best wishes.

flipper44

03/27/23 8:58 PM

#580943 RE: flipper44 #580932

Ignore at your own risk. :-) Could get busy tomorrow.

LearningEveryTrade

03/27/23 9:14 PM

#580950 RE: flipper44 #580932

Flipper GMP was there 3/20

pgsd

03/27/23 10:42 PM

#580961 RE: flipper44 #580932

580156

pgsd
RE: None

03/24/2023 01:16 PM
Post
#
580156
of 580960
There are currently 2 entries on MHRA website for Advent:-

UK MIA 54923
which has a 'legal basis' of....'Human'

and

UK MIA(IMP) 54923
which has a 'legal basis' of....'Investigational'

I have sourced a MHRA Inspectorate Q&A regarding Manufacture of Investigational Medicinal Products. Guess the main takeaway is I was relieved to see we also had the 'Human' approval as well as the 'Investigational'

https://mhrainspectorate.blog.gov.uk/2023/02/03/manufacture-of-investigational-medicinal-products-frequently-asked-questions/

https://cms.mhra.gov.uk/mhra/mia?f%5B0%5D=authorisation_holder%3AADVENT%20BIOSERVICES%20LTD

attilathehunt

03/28/23 10:40 AM

#581052 RE: flipper44 #580932

What significance (if any) does the back date reveal?