John_Shepard
Registered
Hi everyone,
In healthcare establishments in Europe, we'll need (better later than never!) to follow a regulation (PIC/S 010-004 - a GMP-light-like) to produce sterile drugs.
In our case, it's radiopharmaceuticals.
We have to upgrade our current facilities, for the moment not fit these regulations.
But we own a GMP area too.
The question is : can we use this GMP area to product non-GMP drugs, in a separate timing of course ?
In my opinion, yes we could, but we shouldn't.
Inspectors are not very comfortable with mixed areas, right ?
Thanks !
In healthcare establishments in Europe, we'll need (better later than never!) to follow a regulation (PIC/S 010-004 - a GMP-light-like) to produce sterile drugs.
In our case, it's radiopharmaceuticals.
We have to upgrade our current facilities, for the moment not fit these regulations.
But we own a GMP area too.
The question is : can we use this GMP area to product non-GMP drugs, in a separate timing of course ?
In my opinion, yes we could, but we shouldn't.
Inspectors are not very comfortable with mixed areas, right ?
Thanks !
