If I am an inspector inspecting a sterile facility. I wanted to go inside Grade B area, but was refused to do so unless I do the qualification programme as per the company’s policy and Sop of qualification of Gowning ( 3 days programme). Are they entitled to refuse entry
Inspector can enter to aseptic area with an authorized person.
It should be mentioned in their sop.
These days companies are playing smart move to avoid auditors entering into the sterile facility. they have their procedures modified such that you have to undergo some gowning and personal qualification before making an entry to the area.
if you want to enter into the sterile/aseptic area when some production activity is going on…its better you should avoid entering, however you may request when area is idle.
for regulatory inspectors they don’t have any SOP, they simply allow, moreover regulatory inspectors are trained in such a way that they know the procedures and precautions of aseptic areas and they give declaration also that they are trained.
Almost all companies have see through glass from where you can view the aseptic practices and i hope that also suffice the audit’s requirement.
Hope it help.
Thank you all for your useful responses