GMP for utilities design for med. device company

[Boiler1]

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

 

[Drazen]

i don't believe you can easily find overall guidebook, consultancies specialized in pharmaceutics and similar fields charge very much for providing quality manuals. that is simply know-how and noone shares it for free.

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.

 

[Boiler1]

Thanks Dražen - it makes sense but that’s what I was afraid of.
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

 

[Drazen]

that is way how you can proceed - once you find specific requirements your utilities have to meet, than you look for system that can satisfy it.

if you have some very specific question, you can try to post it here.