How to Audit a GMP Certified Supplement Manufacturer?
Nutraceutical Manufacture
11 November 2025

Thinking about getting someone to make your supplements? Hold up — it’s not as simple as printing your logo on a T-shirt. The supplement world is full of rules, tests, and checks. If your manufacturer messes up, your brand could be in trouble before you even start selling.

That’s why GMP (Good Manufacturing Practices) matter. Think of them like the “do it right” rules for making supplements. They make sure every capsule, gummy, or powder is made clean, safe, and the same every time. A GMP certified manufacturer actually follows proper hygiene, testing, and paperwork so your product doesn’t end up shady.

So before you jump in, read this guide. It’ll help you tell the difference between real GMP manufacturers and the ones just pretending — so you can pick a partner that makes safe, good-quality supplements your customers can trust.

What to Ask Before Hiring a Supplement Manufacturer?

Before you pick a top leading supplement manufacturer, slow down. Don’t just get excited by the shiny machines or cheap quotes. You need to check if they actually follow GMP (Good Manufacturing Practices), that’s what keeps your product safe, clean, and real.

Here’s a simple pre-audit checklist — the basic stuff you should ask a contract manufacturer before hiring them. If they can’t answer these, it’s time to walk away.

1. Ask for Their GMP Certificates and Scope

First things first, you should always ask for proof. A good GMP certified manufacturer will have a valid certificate that says:

  • Who gave it (like WHO, FDA, or another authority)
  • What types of products it covers — powders, capsules, gummies, or tablets

If they say “we’re in the process” or “we’re applying soon,” that’s a red flag. GMP isn’t optional.

2. Check Their Recent Audit Reports or Inspection Records

You want a manufacturer that’s been checked by third-party auditors (like ISPE) or regulatory bodies.
Ask for:

  • The date of their last inspection
  • What issues were found (if any)
  • How they fixed those issues

If they’ve never been inspected or can’t show records, big no.

3. Request Sample COAs (Certificates of Analysis)

A COA proves what’s inside their raw materials and final product.
Ask them to show:

  • One COA for raw materials
  • One COA for a finished batch

The COA should clearly show purity, potency, heavy metals, and microbial results.
If it’s blank or vague, they probably don’t do proper testing — not good.

4. Review Their Batch Records and SOPs

Every real GMP certified manufacturer has Master Batch Records (MBRs) and Standard Operating Procedures (SOPs). You don’t need to see trade secrets — just make sure they:

  • Record each production step properly
  • Follow written procedures for everything

If their paperwork looks messy or incomplete, expect the same from their supplements.

5. Ask About Their Lab Testing and Accreditations

Good manufacturers either have their own QA/QC lab or work with accredited ones.
Ask if their lab is ISO/IEC 17025 certified — that’s a big deal.
They should be able to test for:

  • Microbes
  • Heavy metals
  • Ingredient strength
  • Stability

If they say “we just trust our suppliers,” that’s your cue to leave.

How to Audit a GMP Certified Supplement Manufacturer?

Alright, let’s keep this simple. If you’re working with a GMP certified health supplement manufacturer, you can’t just trust the documents, you should always see the place yourself.

There are a few criteria that needs to be fulfilled without fail, to call a third party health supplement manufacturer certified by GMP. Below are the key pointers that you should check during your audit:

Facility & Hygiene

First thing — look around. Is the place clean? Does it make sense?
If not, that’s already a bad start.

  • Stuff should move in one clear line — raw materials go in, products come out, no back-and-forth mess.
  • Workers should wear clean clothes, gloves, hairnets — and only go where they’re supposed to.
  • There should be proof they clean often — like pest control logs and cleaning checklists.

If the floor’s dirty, things smell weird, or people look careless, walk away. That’s not how a GMP certified manufacturer should run things.

Personnel & Training

The people on the floor make the supplements, so they better know their stuff.

  • Make sure their training records aren’t from the dinosaur age — they should be recent.
  • Everyone should know what their job is and who’s in charge if something goes wrong.
  • Basic hygiene isn’t optional — clean clothes, hairnets, gloves, the whole deal.

If you ask someone what they do when there’s a problem and they stare at you like it’s a trick question, that’s a big red flag.

Equipment & Calibration

Machines matter. If they’re not maintained, the product’s at risk.

  • Look for maintenance and calibration logs.
  • Cleaning between product batches should be done properly.
  • Allergen products should be handled on separate or fully cleaned lines.

Old stickers or dusty equipment? Big red flag.

Production Controls & SOPs

This is the “follow the rules” part of GMP certified manufacturing.

  • Master batch records and SOPs should be complete and followed.
  • In-process checks must be done during production.
  • There should be a clear system for handling issues or delays.

If they say they’ll “fill it out later,” that’s a bad sign.

Quality Control & Laboratory

Here’s where the quality really gets tested.

  • Labs should have proper testing methods and documentation.
  • Every batch needs testing for microbes, heavy metals, and stability.
  • Each product should have a ready.

If the lab looks unused or empty,something’s wrong.

Supplier Qualification & Incoming Materials

Good materials mean good supplements.

  • Check if the manufacturer audits their raw material suppliers.
  • Verify that COAs are reviewed and not just accepted blindly.
  • Make sure there’s an inspection process for new materials.

If ingredients just “show up” with no checks, that’s not a true GMP setup.

Documentation & Traceability

In GMP, paperwork is everything.

  • You should be able to trace any supplement from the raw material to the final product.
  • There should be proper records for changes, errors, and fixes (CAPA).
  • Everything must be documented — no shortcuts.

If they can’t show how one product batch was made, walk away.

Conclusion

Finding the right third party supplement manufacturer isn’t about flashy presentations or low prices — it’s about trust, compliance, and consistency. A real GMP certified manufacturer will always have their paperwork in order, their facility spotless, and their people trained and ready.

If a manufacturer hesitates to share documents, hides their audit history, or gives vague answers, that’s your cue to walk away. Cutting corners on quality might save money upfront, but it’ll cost your brand its reputation later.

At Abha Biotechnology, we help supplement brands stay compliant and competitive with GMP-certified, third-party supplement manufacturing solutions. Our facilities follow strict hygiene, testing, and documentation standards, ensuring your products meet both global safety norms and consumer expectations.

Partner with Abha Biotechnology, your trusted GMP certified and the best third party health supplement manufacturer in India, to build safe, tested, and high-quality supplements your customers can trust.

Frequently Asked Questions

GMP stands for Good Manufacturing Practices. It means the supplement manufacturer follows strict rules to make sure every product is safe, clean, and made consistently. A GMP certified manufacturer keeps detailed records, maintains hygiene, and tests every batch for quality.

Always ask for their GMP certificate and check who issued it, like FDA, WHO, or ISO. Look at the scope (types of products covered) and expiry date. If they can’t show a valid certificate or say “it’s in process,” that’s a red flag.

A COA proves what’s inside the supplement — its ingredients, potency, and purity. It’s the easiest way to confirm that your manufacturer tests raw materials and finished products for things like heavy metals, microbes, and strength.

During an audit, check for clean facilities, proper hygiene, updated training records, equipment maintenance logs, and complete batch records. Ask questions and see if workers actually know what to do when a problem comes up, that tells you a lot.

Pick a GMP certified third-party manufacturer with strong testing, documentation, and traceability systems. They should have a clean facility, clear SOPs, and be open about audit results. Always go for quality and compliance over cheap pricing — it protects your brand in the long run.