Re: Wall curvature (between wall & floor) as required by GMP
We are also constructing a new "clean" room. From everything that I have been told, the cGMP question is not what are the angles of the floor to wall but how do you show that the environmental conditions (viable and non-viable) meet the requirements of your product. I have yet to have an inspector ask about the angle of the floor to wall, they have asked to see objective evidence that the room meets product requirements and it is under control (monitoring). With that said, there are initial minimal room requirements if you are claiming a Certified Classification.