FDA GMPs required for the bottling of animal supplements
Hello, I have a question regarding FDA GMP's required for the bottling of animal supplements. From my understanding "animal supplement" is not a recognized category per the FDA and it instead would be considered an "animal food". I am trying to put together an audit checklist for GMPs of a company that receives bulk capsules and bottles them, labels, and packages. They do not manufacture the capsules. I wanted to see if anyone had any guidance or checklists that would reflect the type of GMPs and procedures this company would need to have in place. I am familiar with the requirements of SQF and dietary supplements. Would the GMP's be similar? Thank you.
Good morning Sarah,
Short answer is that yes, the GMP's would probably be similar for the majority. Some things you will want to do, if you haven't already:
- Become familiar with FDA's requirements for animal food CFR
- Schedule and take a PCQI for animal feed/food course
- FSPCA has their own courses/training books specifically for animals
Just to give an example of one difference I've encountered in the CFR: it's ok to store bulk animal food final product OUTSIDE, as long as there are no associated pest or bio issues. For human food, that would be a no-go.
Edit: After reviewing my post, it could be misconstrued that FSPCA is giving training courses for the animals themselves. I'm going to leave it in, because that would HILLARIOUS.
Sarah,
If the company is by any chance an NASC company, NASC has a really comprehensive GMP manual that I follow. I'm in the horse supplement industry and we are also FDA inspected. We manufacture and package but the requirements are essentially the same across both regulating agencies. The NASC does not mess around when it comes to their requirements and audits!
No, the company is not NASC. They actually manufacture cosmetics as well. They follow GMP's but I was not sure how far down the rabbit hole I should go for this audit. It looks like I will have to audit against 21 CFR part 507 like Tim suggested.
Tim-
"FSPCA has their own courses/training books specifically for animals" This had my dying after I re-read it. Very funny! Thank you! I did take that course myself for both animal and human food. I wasn't sure if because they are only putting the pills in bottles if we needed all of 507 but it makes sense. It is going to be a long audit then!
Hey, double check your exemptions and make sure they aren't exempt:
Subpart A - General Provisions
Sec. 507.5 Exemptions.(9) Vitamins, minerals, and concentrates;
Looks to me like they might be, but you'll want to verify with legal counsel (preferably food law) if possible.
Hm. It sounds like they may be exempt. If so, where would that lead my audit scope direction? General GMPs?
Well, let's check one more thing.
- Are they required to register with FDA?
Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA.
It sounded like they stayed clear of the animal drug area and just do supplements. If that's the case, and you don't have to register, do you have any other standards the facility is under? Are there specific customer requirements?
Ultimately, it sounds like you'll be able to use the animal food cGMP's and your own previous experience with SQF and supplements to put together a pretty flexible site specific inspection/checklists. You can still do it risk based, but it offers the the freedom of not having an FDA auditor show up and be able to dictate what you follow.
Thank you, yes, they are registered with the FDA. I have been searching for an animal food GMP checklist to make this easier. Does anyone know where I can find such a thing?