GMP for utilities design for med. device company
GMP for utilities design for med. device company
(OP)
Hi,
I would really appreciate a guidance as to where to purcahse a reasonably comprehensive Current Good Manufacturing practice for utilities design for medical devicees manufacturing company.
I tried FDA but nothing apparent comes up.
I would need a GMP guide taht would walk metherough critical utilities design ( process cooling water, oil free air, process vacuum etc.
It's contact lenses manuf facility.
Many thanks
I would really appreciate a guidance as to where to purcahse a reasonably comprehensive Current Good Manufacturing practice for utilities design for medical devicees manufacturing company.
I tried FDA but nothing apparent comes up.
I would need a GMP guide taht would walk metherough critical utilities design ( process cooling water, oil free air, process vacuum etc.
It's contact lenses manuf facility.
Many thanks





RE: GMP for utilities design for med. device company
the best you can do is to ask your client, presumably medical devices company, to give your their quality manuals, which will be initial point for your development, they are more important than any generic recommendations.
RE: GMP for utilities design for med. device company
I've been generally involved in design and installation while this role assumes some gap analysis and bringing the utilities specs in line with CGMP.
Will start with Quality Manual and hope for the best.
Many Thanks
RE: GMP for utilities design for med. device company
if you have some very specific question, you can try to post it here.