NSF/ANSI 455-2
Our facility is GMP-registered under NSF/ANSI 455-2 — the Good Manufacturing Practice standard for dietary supplements. This covers facility design, equipment sanitation, personnel training, and documentation practices.
21 CFR Part 111
We comply with FDA's current GMP requirements for dietary supplements (21 CFR 111), which mandate identity testing, finished product testing, stability programs, and master manufacturing records for every batch.
NSF/ANSI 173
Equipment sanitation follows NSF/ANSI 173 for dietary supplement equipment — including allergen cross-contact prevention, cleaning validation, and residue testing protocols.
ISO 9001:2015
Our quality management system is certified to ISO 9001:2015 for supplement manufacturing, covering supplier qualification, corrective actions, internal auditing, and continuous improvement.
From raw material to finished bottle
Raw material qualification
Every botanical lot is sourced with a Certificate of Analysis (COA) and authenticated by organoleptic evaluation and HPTLC fingerprinting before acceptance.
Extraction & standardization
Botanicals are extracted using the appropriate solvent (water, ethanol, or hydroethanolic) and standardized to a guaranteed percentage of active marker compounds by HPLC-UV.
In-process quality control
During blending and encapsulation, samples are pulled at defined intervals for identity, potency, and uniformity testing. Results must fall within validated acceptance criteria before the batch proceeds.
Finished product testing
Every finished batch undergoes potency testing (HPLC-UV), heavy metal screening (ICP-MS), microbiological testing (USP 61/62), and physical specification checks (weight, hardness, disintegration).
Third-party verification
An independent ISO 17025-accredited lab retests a random sample from every batch for heavy metals, microbiology, and potency before the batch is cleared for release.
Batch release & retention
Approved batches are logged with a unique lot number, and retained samples are archived for stability monitoring and full regulatory traceability for the product's shelf life plus one year.
Third-party testing specifications
| Test | Method | Specification |
|---|---|---|
| Potency (active compounds) | HPLC-UV | ±5% of label claim |
| Heavy metals — Lead | ICP-MS | ≤0.5 μg/g |
| Heavy metals — Arsenic | ICP-MS | ≤1.0 μg/g |
| Heavy metals — Cadmium | ICP-MS | ≤0.3 μg/g |
| Heavy metals — Mercury | ICP-MS | ≤0.1 μg/g |
| Total plate count | USP 61 | ≤1,000 CFU/g |
| Yeast & mold | USP 62 | ≤100 CFU/g |
| E. coli / Salmonella | USP 62 | Absent in 10 g |
| Staphylococcus aureus | USP 62 | Absent in 10 g |