GMP sanitation practices

Hempire Building GMP
1

As we are writing up regulations for GMP, I was wondering if anyone has good sanitation practices in their labs that is currently certified GMP. What is used on glassware, countertops, floors, etc. and what protocols are in place?

Thanks in advance!

2

We are still in the process of getting the certification, but I was personally certified and built our protocols on 21 CFR 111 from the FDA

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3

Could you speak more about the process please. How long did it take. How much did it cost. I know there are different levels of gmp but i have heard it can cost up to 250k once everything is said and done. That sounds like a very high price to me.

4

How much do you plan on paying your inhouse GMP compliance officer each year? 250k sounds like a bargain for everything GMP entails

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5

To be totally honest i was just talking about the up front costs to get it done. I hadnt considered the compliance officer so it looks like from what you saying 250k is on the lower side.

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6

I highly recommend finding a good GMP consultant. The answer to every one of your questions will be “it depends” and someone who can clairify things is worth their weight in gold. A few thousand on a basic high level consult is well worth the time and headache it’s going to save you in the long run. If you don’t have the money for that consult, you do not have the money to be GMP compliant.

Can you do it all yourself? Sure, but what is your time worth? Expect literally multiple man years of work to get compliant in any non-trivial facility, if you’re doing it from scratch.

I’ve seen realistic estimates of tens of millions of dollars to retrofit existing facilities to bring them into compliance. Depends entirely on your starting place. Our total cost to ensure that we will be ready for our GMP cert when we want it is likely in the low hundreds of thousands range, on a brand new facility. Most other companies would likely be in the high hundreds of thousands range or more as we have lots of skilled engineers on staff and don’t need to farm much out other than true specialty stuff.

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