GMP Specs for plant design - Reference : Flooring and other questions

[therunningbruce]

Im not sure exactly where to post this.

I'm supporting a GMP plant. I after a design guide for general GMP practice..

is it a GMP requirement to have flooring plate ? (on 1st,2nd. 3rd floors..)

or is the requirement just to be clean.. and generally structural steel floors are plated to ensure this..

are their GMP regulations or is it audits and best practice..e.g. in the EU you must do this.. in UK you must do , USA you must do..

 

[pierreick]

Hi,
You should consult people (specialized engineering) knowledgeable about cGMP, don't take it light you may go for trouble with the inspectors if your set up is not done properly at the start. It has to do with contamination. FDA is supplying guidelines; you may also consider hiring a cGMP consultant to support you on this project.
It has nothing to do with sweeping the floor!

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211

Note: If you are compliant with US FDA there is a great chance you will be compliant with FDA from other countries.
Based on experience
Good luck
Pierre

 

[therunningbruce]

thanks for response,

its a good manufacturing plant for customer requests e.g. cosmetics not food.. I assume thats different.

cGMP consultant or cosmetics or other..sorry if i dont understand.

from what ive read gmp does state the area must be clean. so surely a solid floor is enabling that requirement but if you had bolted floor if it can be kept clean then that meets it right?

it seems to be for plant build its about making it cleanable..and thats up to designers and operators to accept..and audits manage how well.it works..

 

[bimr]

Another reference:

Reference Link

 

[EdStainless]

While some of rules (such as FDA) are specific to food many of the rules apply to any product that must be hygienic.
The ability to clean, sanitize, and verify will apply in all cases.
Seek out certifying authorities.
I know in many fields insurance companies are a good source of information.

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P.E. Metallurgy, consulting work welcomed

 

[therunningbruce]

thankyou,

it seems to be design is not so specific its all about how you record installations and design to keep clean and cleaning of before commissioning etc..

so an example..I could use mineral wool insulation provided its sealed and procedures and methods to keep away from open manways..

the same with flooring..it just must be kept clean..and have the ability to keep clean..how is down to plant and to be effective at it with records.