Quality Assurance & Manufacturing
How every batch is made — and how it is proven
Safety, identity and purity are not claims we ask you to take on trust. They are built into a documented Quality Control System — and, since May 2026, independently certified.
Our facility operates in strict accordance with the current Good Manufacturing Practice (cGMP) regulations for dietary supplements, as established by the U.S. Food and Drug Administration under 21 CFR Part 111. That system governs every stage of our operations, from raw material approval to the release of a finished bottle.
Now Officially GMP Certified
Certified by SGS to cGMP — 21 CFR Part 111
AMPEXT® (American Plant Extraction, LLC) is certified by SGS, one of the world's most trusted certification bodies, to cGMP under 21 CFR Part 111 — the FDA's Good Manufacturing Practice standard for dietary supplements — for the production and handling of herbal extracts. It is independent, audited confirmation of what we have practiced from day one: your supplements are made right, every single batch.
- Standard — cGMP, 21 CFR Part 111 (FDA, dietary supplements)
- Scope — production and handling of herbal extracts
- Certified by — SGS, independent third-party audit
- Certificate No. — US26/00000249
- Valid — 08 May 2026 – 07 May 2029
The Quality Control System, stage by stage
A certificate confirms the system; the system is what actually protects the product. Ours runs in four controlled stages, and nothing moves to the next stage until the previous one is signed off.
Supplier Qualification & Specifications
Quality control begins long before anything reaches the extractor.
- We work exclusively with approved suppliers who have successfully passed our internal qualification procedures.
- We conduct thorough risk assessments for all incoming materials to determine the necessary verification steps.
- Our Quality Control unit establishes and approves rigorous specifications for every incoming component — botanical raw materials, menstruum and packaging — covering identity, purity, strength and limits on contaminants.
Raw Material Identity & QC Testing
No ingredient enters production without analytical confirmation that it meets specification.
- Quarantine. All incoming raw materials are placed in physical and electronic quarantine on receipt, pending laboratory results.
- Identity testing (§ 111.75). We carry out 100% identity verification on every botanical raw material we receive, eliminating the risk of species substitution or adulteration.
- In-house analytical laboratory. Testing is done on our own instruments rather than taken on a supplier's word — see the laboratory section below.
Controlled & Documented Manufacturing
Every step of extraction is controlled so that batch fifty matches batch one.
- A Master Manufacturing Record (MMR) is established for each product, dictating the exact formulation, extraction ratios, temperature parameters and standard operating procedures.
- The production of each specific batch is meticulously documented in a Batch Production Record (BPR).
Maintaining the BPR gives complete traceability of every ingredient, operator action and piece of equipment — from the finished bottle back to the original raw material lot.
Finished Product Testing & Release
The last gate before a batch is allowed to leave the building.
- Representative samples are drawn from every manufactured batch.
- Finished products are tested against all final specifications, including appearance, specific gravity and organoleptic properties.
- A batch receives "Released for Distribution" status only after an authorised member of the Quality Control unit has reviewed and signed off all production and laboratory documentation for that batch.
In accordance with federal regulations, we securely maintain retained samples from every manufactured batch, so any lot can be re-examined later if it is ever needed.
Our in-house analytical laboratory
To keep precision uncompromising — and turnaround fast enough to act on — we test in our own laboratory, equipped with instruments normally found in contract analytical labs.
CAMAG · HPTLC
Botanical fingerprinting
High-Performance Thin-Layer Chromatography for precise botanical identification — the visual fingerprint that confirms a plant is what it claims to be.
Thermo Fisher & Shimadzu · FTIR
Chemical identity
Fourier-Transform Infrared Spectroscopy to confirm the exact chemical identity of incoming raw materials.
Shimadzu · ICP-OES
Heavy metals screening
Inductively Coupled Plasma Optical Emission Spectroscopy for rigorous screening of lead, arsenic, cadmium and mercury.
Independent third-party laboratories. For highly specific assays — advanced microbiological screening in particular — we consistently partner with accredited, independent laboratories. Some checks should be run by someone with no stake in the result.
Why we hold this line
Compliance with 21 CFR Part 111, a state-of-the-art analytical laboratory and strict internal documentation are not merely regulatory obligations — they are the foundation of our manufacturing philosophy. Our science-based approach means there are no compromises when it comes to safety, identity and purity.
Choosing our botanical extracts means choosing a professional-grade product where every single batch is scientifically verified, meticulously documented, and now independently certified against the most rigorous quality standard in the U.S. dietary supplement industry.
Made right, documented fully, and audited by someone other than us.
These statements have not been evaluated by the Food and Drug Administration. Our products are not intended to diagnose, treat, cure or prevent any disease. cGMP certification concerns manufacturing practices and quality systems; it is not an evaluation or endorsement of any health claim.