That needs to be in the GLG data dump
This is why we need more regulation.
See, that’s now how gmp works- by definition you cannot just take a product made in a wooks garage and take it to a facility to get it certified…
so what you are admitting to doing is committing regulatory fraud, and that’s illegal.
are you finding these requirements in the pharmaceuticals or dietary supplements guidelines ?
the facility requirements im looking at don’t mention HEPA filtration.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=111.20
https://www.fda.gov/media/92841/download
I’ll have to cross reference and verify the HEPA thing with the latest guidance docs i found.
is there a link for it or does that normally get sent to Future? I tried looking for an upload on the GLG portal but there wasn’t one
*edit: I found it with a little google fu
“so what you are admitting to doing is committing regulatory fraud, and that’s illegal.” this part right here. 100% facts
Nobody on this forum would ever do anything illegal
Its funny to watch the people that came from the BM call out other folks about following the law
as one of the few that are cGMP maybe you can clarify if your production lines need to be in a clean room ? just curious because i saw this picture on your site and it looks like a fairly standard manufacturing facility with epoxy flooring and drop in ceiling tiles from what I can make out .
Show us the way
I don’t work in our compliance department so I don’t know all the nuances involved but we do have three formulation bays there that are seperate from the bottling lines. This ensures that there aren’t any dust particles etc in the bottling line area. There is also a room where your have to change clothes, put on hair nets, and shoe coverings etc. Then clean your hands when entering the bottling line room. There are also requirements for the ceilings, walls, and floors but I do not know what all goes into that.
Edit: There are a lot of requirements around distance of plants/trees from the outside of the building, pest mitigation programs, no phones, no jewlery etc.
Im not sure their ceiling tiles are GMP compliant, but you can buy GMP compliant ceiling tiles. As far as the dust in the air, thats a function of your air handling unit. To be compliant, the air must be filtered and exchanged so many times per cubic feet.
@steelrollin We will have everything you mentioned, but want be complaint at the start of the show. There is way bigger checklist than that.
Do you mind sharing how you clean you China tincture bottles and the droppers?
i get that but does gmp mean a suoervisor looking over the shoulder constantly? Its still the same shit that comes out of walmart, it doesnt mean quality. Although im a walmart fan, the beef and olive oil is good at least. its all gmp certified LOL
im not as dirty as my dog but if I brush my skin I see particles flying in the right sunlight. I think its that way and has always been. To think that any environment is steriile is nonsense. Im running multiple dust shrooms 24 7 and my house is still dusty.
Gmp standards will have in place QC so yeah someone should be looking over you shoulder and checking off on work done as well as cleaning processes. The QC can be done by any supervisor or whatever that’s already working there.
Think of it as requiring people to follow the rules and then having them write down what they did to follow those rules proving work was done
kinda like atmcdonalds they wipe the table down and write it down for proof. I hate when things get that supervisory. On some level its necessary, on the other level id quit if the supervisor was a dork or an ass under that kinda program
We just finished up our GMP training, HAACP, and currently implementing all the record keeping to do an pre audit and them full GMP audit in about 3 months in our NY facility. Cost about $30k working with an outside company. The heavy lifting is in recording keeping.
I am well aware. You can check the NSF cGMP website for our certifications. We actually just finished up our yearly audit the other week and got an A. I don’t know of many companies that get A’s on their audit reports to be honest with you. As I said I do not run our compliance department we have a Quality Assurance director that handles all of our compliance and audits which is also required by cGMP.
there is no need to clean the bottles as they are food grade and approved for use without any cleaning. lol. I see you have some salty vibes coming my way. Happy to address whatever has got your panties in a bunch.
Edit: I’ll just put the link here for ya Listing Category Search Page | NSF International and I’m sure you are aware but NSF is the gold standard for cGMP auditing agencies.