Turning a Small Facility cGMP

This topic contains 2 replies, has 3 voices, and was last updated by Profile photo of Jonathan Bechtel Jonathan Bechtel 2 years, 11 months ago.

Viewing 3 posts - 1 through 3 (of 3 total)
  • Author
    Posts
  • #369
    Profile photo of Tyler West
    Tyler West
    Participant

    Hey all,

    Has anyone tried to make their own GMP compliant facility? Note that this is obviously a large up front cost if you are looking to make a product that requires very even blending or mixing since you’ll need a large up front cost for ribbon mixers or tumblers. But for products that are simpler blends that might not need a fancier mixer for blending or just repack operations (opening a large manufacturer’s package and repacking into smaller bags for consumer distribution), it seems like it might be possible to “DIY” a facility out of a garage or small metal building (even a portable aluminum building?) on your property, or a cheaply rented small space in a more industrial part of town. Or even a room in another building of someone else’s commercial property, such as the back room of a gym or fitness studio.

    From what I’ve seen, most of cGMP compliance focuses on the recordkeeping and testing of the product, meaning you would have to take analysis into your own hands. These details are spelled out in detail in the extremely convoluted language of CFR 211. What I can’t seem to figure out is the facility requirements, if say, an FDA inspector decided to drop by. From what I’ve seen from most of the facilities I’ve toured of distributors of supplements, repacking requires a room that can be easily cleaned (tile floor, nonporous work surfaces such as stainless steel), and no ventilation ducts into the room. But this is the extent of the only things I’ve noticed about these facilities.

    Does anyone else have any insight into CFR211’s requirements for the facility itself, or experience starting up a small GMP compliant operation without outsourcing to manufacturers? My girlfriend works at a corporate GNC location and has met the CEO of Cellucor, a large US based sports supplement company, who literally started it out of his garage in Denton, TX in 2002 (5 years before GMP).

    GMP certainly makes the “garage startup” very difficult in 2015, but I’m wondering if it’s completely infeasible for a simple repack operation, if say you had access to an analytical laboratory to which you could outsource testing and kept all of the necessary logbooks.

    #375
    Profile photo of Jay Thomas
    Jay Thomas
    Participant

    interesting question. i’m pretty sure you need temperature controls and certain protocols have to be followed for how ingredients are stored, which might be difficult if you’re doing it on your own.

    to be honest i doubt the guys who started their operations in their basement were all that worried about being gmp compliant when they first started, it was just a way to get around the order minimums most manufacturers have.

    #378
    Profile photo of Jonathan Bechtel
    Jonathan Bechtel
    Keymaster

    There are protocols for testing, ingredient storage, how far apart things are, record keeping, temperature/humidity, etc. It gets complicated pretty quickly I think.

    However…..if it was just your products it might be a lot easier.

    I’d guess the equipment costs would be at least $10,000 if you bought things used and you’d probably need at least 1 other person to work the line….so there’s definitely a good bit up startup planning required.

    Lots of supplements can be made with a manufacturer pretty cheap so it’s a bit dicey going this route.

    To be honest I doubt those guys starting in their basement were GMP compliant. I know some people in the industry who think they’re a joke and very loosely regulated.

    Have you come to any decisions about whether or not you’re going to go in this direction or not?

    Owner of Health Kismet . Open to answering any and all questions.
Viewing 3 posts - 1 through 3 (of 3 total)

You must be logged in to reply to this topic.