Non_GMP (PIC/S 010) production in a GMP area ?

J

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 !
 
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