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A Few More Queries on our Recent GMP Inspection Report
We are currently working through the latest GMP audit report for our cosmetics production facility. Would be interested in opinions on the following items in the inspection report.
3.1 Some weaknesses has been found in the Changing Room
3.1.1 No control (i.e. cross over bench) provided to separate controlled area and non-controlled area in that room.
3.1.2 Wall fan is used in that room.
I’m not sure what items would go into the production area via “cross over bench.” We had the layout appovedby this Department, and everything goes into the production area via a seperate buffer zone. The Changing room is only designed for staff entry into the production area.
We are in the tropics, so fan is for staff comfort. The door into the change room from outside, and door into the production area have seals, and both remain closed during changing. Any ideas what the issue may be.
What annoys me is that they make these comments but never link them to a particular section of the GMP regulations.
Any suggestions on the above two items highly appreciated.
Thanks.
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1 Reply
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@mikethair include a stainless steel bench and remove the wall fans (big NO for the fans).
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