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Can you please explain, in laymans terms, what the following are:
GMP PET radioisotope labelling and production
Hot2 chemistry
Cold Chemistry labelling
GMP and non GMP storage
The MHRA and OUHT
I-so-tope you can help me (sorry)
Feel qualified to answer only one of those.
GMP vs non-GMP.
cGMP - (current) Good manufacturing practice. For us that means a full record of everything.
How did you choose equipment for storage - Are you trained/approved to do so?
How did you install equipment for storage - are you trained/approved to do so?
How did you prove it's working as per your/manufacturers specification, are you trained/approved to do so?
Etc etc etc - A large chunk of the costs of pharmacuetical stuff is paying people to do all this and you regularly audit yourselves and often external people will audit you.
As above, I mainly worked to GLP, which is like GMP on steroids.
SOPs detailing methods for everything, all on controlled documents so that they have a version and review date
Training records that document all staff are signed off on the current SOP before doing a task
Data handling procedures
Calibration records
Internal audit process for above
External audit (That's where MHRA come in)
Etc.
MHRA = Medicines and Healthcare products Regulatory Agency
They are the regulatory body from New drug development and testing to distribution.
[url= http://www.mhra.gov.uk ]MHRA[/url]
Thanks Saccades, that makes some sense. I've worked out what Positron emission tomography is now (very basically) with some googling.
I assume Hot Cell refers to the fuel/medium rather than part of the infrastructure (I'm interested in the infrastructure only)
Cheers guys, some more blanks filled!
A 'hot' cell is essentially a container within which radioactive materials can be manipulated, providing a safe barrier to the operator.
No worries - Can tell I've been out of the UK too long - had no idea who MHRA was until I looked it up (used to be MCA back in my day).
As above, I mainly worked to GLP, which is like GMP on steroids.SOPs detailing methods for everything, all on controlled documents so that they have a version and review date
Training records that document all staff are signed off on the current SOP before doing a task
Data handling procedures
Calibration records
Internal audit process for above
External audit (That's where MHRA come in)
Etc.
GxP encompasses all of the above and more, seems the more common term in IT circles in supporting systems - just in case you're looking for work and that pops up.
From my point of view, it generally means another acronym - PITA. I'll let you google that if necessary 😀