Ownership of Pre-Clinical cGMP Stability Testing

M

mwmather

#1
Hi all! I am new to pre-clinical cGMP, but am being told that I am the owner/author of the Stability Protocol? I am the only QA person here, but I have never had QA take ownership of a process in this manner. Thoughts please?
 
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Ajit Basrur

Staff member
Admin
#2
Hi all! I am new to pre-clinical cGMP, but am being told that I am the owner/author of the Stability Protocol? I am the only QA person here, but I have never had QA take ownership of a process in this manner. Thoughts please?
Welcome to the Cove :bigwave:

It all depends on your Organization structure and how the different roles and responsibilities are defined. Many bif corporations have a seperate Stability group that is responsible for all stability testing or it could be the R & D or in some, it could be part of the Quality group.
 
M

mwmather

#3
We're a very small company and I came from big pharma, so many of these practices are foreign to me. As QA, I was always remote from other aspects of R&D, but now I'm in the middle of it all. It's a big change!!
 
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