Vitamin K2 — The Full Documentation Chain
All-trans MK-7
Status: in development / target specifications. Real CoA results will be published as the first production batch is tested; the D3 page already shows live results.
The principle: a supplement is only as trustworthy as its weakest undocumented step. So we document every step — from the raw ingredient to the bottle in your hands — and for every certificate we explain, in plain language, why it exists. A certificate you don’t understand protects nobody.
Stage 1: The source — before anything reaches the factory
Quality cannot be tested into a finished product; it has to arrive with the raw material. Under EU food law (Regulation 178/2002, Art. 17), the operator is legally responsible for everything that goes in.
| Document / Certificate | What it is | Why it exists (in plain language) |
|---|---|---|
| Supplier Certificate of Analysis (CoA) | Test report accompanying every raw-material lot: identity, potency, purity, contaminants. | So we know what actually arrived — not what the invoice says. Ingredient substitution and dilution are the most common forms of supplement fraud; the WHO warns about substandard and falsified products entering legitimate supply chains. |
| Identity testing on receipt | Independent re-check (HPLC/spectroscopy) that the material is the declared compound and form before it is released to production. | A CoA is the supplier’s word; identity testing is our check on it. The correct form matters as much as the correct compound — the wrong isomer or ester can be inactive. How identity testing catches fraud — GMJ News. |
| Pharmacopoeial grade (Ph.Eur./USP) | Where a monograph exists, the ingredient is purchased to European Pharmacopoeia specification. | A pharmacopoeia monograph is a published, public purity standard — it means “pure” has a legal, testable definition instead of being a marketing word. |
| Non-GMO, irradiation-free, BSE/TSE-free specification | The active-ingredient master specification requires: GMO — free; irradiation — free; BSE/TSE — free. | These exclusions are locked at specification level — genetically modified sources, irradiated raw materials and animal-disease risk vectors are ruled out before a single kilogram is purchased. |
Stage 2: Transport to the factory
Actives can degrade before production even begins. Fat-soluble vitamins and oils are sensitive to heat and light in transit.
| Document / Certificate | What it is | Why it exists (in plain language) |
|---|---|---|
| Supplier qualification file | Documented approval of each supplier: audits, history, specifications. | So materials come only from sources with a verified track record — the first firewall against falsified ingredients. |
| Inbound transport & condition records | Shipping documentation including temperature exposure where required; goods inspected on arrival. | Oxidation roughly doubles with every 10 °C of temperature increase (Arrhenius kinetics). A perfect ingredient shipped badly is no longer a perfect ingredient. This follows the logic of EU Good Distribution Practice (GDP). |
Stage 3: The factory — management systems
Every Sheni Labs product is made in one confirmed facility in Poland (EU). These certificates cover the facility itself. Each one is independently audited — never self-declared — and each exists for a specific reason:
| Document / Certificate | What it is | Why it exists (in plain language) |
|---|---|---|
| GMP (Good Manufacturing Practice) | Good Manufacturing Practice per Codex Alimentarius CXC 1-1969 Rev.5 (2023), certified by SGS; certified since 2020, current certificate valid to 29 March 2029 with annual surveillance. | GMP means quality is built into the process — trained staff, qualified equipment, written procedures — instead of hoping to catch problems in the final test. Final testing samples a batch; GMP governs all of it. |
| ISO 22000:2018 | Food safety management system certified by SGS under UKAS accreditation (IAF multilateral recognition); certified since 2023, valid to 29 March 2029. Food category CIV — ambient stable products. | An external auditor returns every year and can withdraw the certificate. It converts “we take safety seriously” into something a third party continuously verifies. |
| HACCP | Hazard analysis and critical control points certified by SGS (CXC 1-1969, latest revision 2022); legally required in the EU under Reg. 852/2004; valid to 29 March 2029. | Instead of only testing the end product, HACCP identifies where in the process contamination could occur and controls those exact points continuously. |
| Halal & Kosher certification | Independent religious certification bodies auditing ingredients, production lines, and packaging. | Beyond serving observant consumers, these are two additional independent organisations that physically inspect the ingredient chain — an extra verification layer at no cost to anyone else. |
| EU food-business registration (GIS) | Entered in the register of the Polish State Sanitary Inspectorate as a Dietary Supplement Manufacturing Company (State District Sanitary Inspectorate, Kraków) under the Polish Act on Safety of Food and Nutrition and Reg. (EC) 852/2004. | Registration means legal accountability: the facility is on a government register, subject to unannounced official inspection, and legally traceable. |
| ISO/IEC 17025 (testing laboratory) | The independent third-party laboratory that releases our batches is itself accredited (ILAC/PCA). | The lab checking the product is also checked. 17025 accreditation means its methods, equipment, and staff competence are audited — so a test result is internationally recognised, not just a printout. |
| Statement of Standards (ethical & dietary) | Manufacturer’s signed declaration: products not tested on animals, cruelty-free, vegan production standards, natural products; gluten-free confirmed by the manufacturer (declaration held on file). | Ethical claims are cheap to print and hard to check — a signed, dated corporate declaration makes them auditable statements rather than marketing words. What a declaration is worth — GMJ News. |
Stage 4: Production of this product
Once materials are released and the facility qualifies, the batch itself is documented end to end.
| Document / Certificate | What it is | Why it exists (in plain language) |
|---|---|---|
| Batch manufacturing record | Complete record of each production run: material lots used, quantities, times, equipment, operators. | Traceability is the legal backbone of EU food law (Reg. 178/2002, Art. 18). If anything is ever wrong, the exact batch — and only that batch — can be identified and recalled. What a LOT number really is — GMJ News. |
| In-process quality control | Samples pulled at the start, middle, and end of each run. | A mixing error shows up during production, when it can still be corrected — not after 10,000 bottles are filled. |
Stage 5: The finished product — independent batch testing
Before release, every batch goes to the ISO/IEC 17025-accredited third-party laboratory. These four tests apply to every Sheni Labs product; the ingredient-specific tests below them are dictated by this product’s chemistry.
| Test | What it measures | Why this test (in plain language) |
|---|---|---|
| Potency assay | Measures the actual amount of active ingredient against the label claim. | Label accuracy is a legal requirement (Reg. 1169/2011) — and independent surveys repeatedly find supplements containing far less (or more) than declared. This is the test that keeps the label honest. How supplements fail label tests — GMJ News. |
| Identity confirmation | Confirms the molecule and its exact form (e.g. the right isomer, ester, or stereochemistry). | Protects against the most profitable fraud: substituting a cheaper, inactive, or wrong-form ingredient that a simple potency test might miss. |
| Heavy metals (ICP-MS) | Lead, arsenic, cadmium, mercury against ICH Q3D (R2) permitted daily exposures for the oral route. | These metals accumulate in the body over years; a daily-use product must be held to strict limits. ICP-MS detects them at parts-per-billion levels. |
| Microbiology (Ph.Eur. 5.1.8) | Total counts, yeasts/moulds, and specified pathogens. | A product taken every day must be microbiologically safe every day. Ph.Eur. 5.1.8 is the European pharmacopoeial standard for non-sterile oral preparations. |
Ingredient-specific tests for this product
The universal panel above applies to every product. Vitamin K2’s own chemistry requires the following additional tests — each with its reason:
Isomer purity — the essential MK-7 test
| Test | Method | Specification | Why this test |
|---|---|---|---|
| All-trans / cis isomer ratio | HPLC (isomer-resolving method) | ≥99.0% all-trans MK-7 | The defining quality test for MK-7. Only the all-trans isomer is biologically active. Fermentation-derived MK-7 is naturally all-trans; this test verifies it and excludes cis contamination. |
| Identity (menaquinone-7) | HPLC-UV vs reference standard / MS | Matches MK-7 reference | Confirms the menaquinone chain length is 7 — distinguishes MK-7 from MK-4, MK-6, and other menaquinones with different pharmacokinetics. |
| Source confirmation (fermentation) | Supplier CoA + audit trail | Fermentation-derived confirmed | Verifies the biological production route (Bacillus subtilis fermentation), which is what guarantees the natural all-trans configuration. |
Potency and purity
| Test | Method | Specification | Notes |
|---|---|---|---|
| MK-7 content per drop | HPLC-UV | 100 µg all-trans MK-7 = 133% EU NRV | Label claim verification. EU NRV for vitamin K = 75 µg (Reg. 1169/2011 Annex XIII). |
| Peroxide value (oil medium) | Ph.Eur. 2.5.5 | ≤5.0 meq O₂/kg | Confirms oxidative stability of the MCT oil medium. MK-7 is light- and oxidation-sensitive. |
| Residual solvents | Ph.Eur. 2.4.24 / GC | ICH Q3C compliant | Verifies no extraction solvent residues from the ingredient purification process. |
Stage 6: Packaging — the materials touching the product
Packaging is in direct, continuous contact with the product for its entire shelf life — so the packaging needs its own certificates.
| Document / Certificate | What it is | Why it exists (in plain language) |
|---|---|---|
| Food-contact declaration — amber glass bottle | Declaration of compliance under EU Reg. 1935/2004 (food-contact materials); UV-filtering amber glass. | Anything touching food must be certified not to transfer harmful substances into it — that is exactly what Reg. 1935/2004 exists for. The amber colour is functional, not aesthetic: it blocks the under-450 nm light that degrades this product’s active. |
| Food-contact declaration — dropper & closure | Compliance documentation for the dropper assembly and cap materials (Reg. 1935/2004 / Reg. 10/2011 for plastics). | The dropper touches the product on every single use. Plastic parts have specific migration limits — certified so nothing leaches into the oil. Each dropper lot additionally arrives with the packaging supplier’s quality-control certificate (glass pipette, HDPE and nitrile components) confirming conformity with the material specification and technical drawing. |
| Carrier oil certificates (MCT, Miglyol® 812 N) | Ph.Eur.-grade specification, own CoA per lot, plus independent Halal and Kosher certificates (IOI Oleochemical). | The carrier oil is most of what is physically in the bottle — it deserves the same scrutiny as the active. Its peroxide value (≤1.0 meq O₂/kg) is what keeps the base oil from going rancid — the most recent supplier CoA measured <0.1 meq O₂/kg and 99.3% content against a ≥95% specification. |
| Inert-gas filling record (where applicable) | Nitrogen/CO₂ atmosphere documented for oxidation-sensitive actives (CoQ10, astaxanthin). | Some actives oxidise on contact with air alone. Removing the air is the only real fix — and it has to be documented per batch, because it is invisible in the finished bottle. |
| Glass, not plastic — the microplastics decision | Amber glass primary packaging instead of plastic bottles, for every product in the line. | Plastic containers can shed micro- and nanoplastic particles into their contents — found in 93% of bottled waters tested (Mason 2018) — and fatty, oil-based liquids are of particular concern for migration. Glass is inert and sheds nothing. For a daily oil taken over years, we remove the question entirely. Glass vs plastic — GMJ News · The full evidence → |
Stage 7: Transport from the factory to Georgia
A tested batch can still be ruined between the factory gate and the warehouse.
| Document / Certificate | What it is | Why it exists (in plain language) |
|---|---|---|
| Shipping & condition documentation | Transport records for each consignment, with protection from extreme heat; temperature-sensitive logic borrowed from pharmaceutical GDP. | Stability data assume the product was kept within its storage conditions. A truck at 60 °C in summer can undo months of shelf life — documentation is how we know it did not happen. Heat kills supplements — GMJ News. |
| Import & customs documentation | Complete legal import trail into Georgia for each consignment. | A documented import chain means every bottle on the Georgian market is traceable to a legal consignment — the difference between an authentic product and a grey import of unknown handling. |
| Georgian state registration (National Food Agency) | The Georgian distributor is a registered food business operator under the Georgian Food/Feed Safety Code; products on the Georgian market are subject to National Food Agency (სურსათის ეროვნული სააგენტო) state control and market surveillance. | A registered Georgian legal entity is accountable to Georgian authorities — you have domestic consumer rights, official recall channels, and a local address responsible for the product, not only a producer abroad. |
Stage 8: Storage in Georgia
The last stage before the product reaches you.
| Document / Certificate | What it is | Why it exists (in plain language) |
|---|---|---|
| Warehouse condition standard | Cool, dry, light-protected storage; conditions matching the label storage instructions. | Every expiry date on the label is only valid if the product was stored as specified. Storage conditions are part of the stability contract with you. |
| FEFO stock rotation | First-expired, first-out rotation records. | Guarantees that the bottle you receive is never an old one that sat behind newer stock — the standard rotation discipline of pharmaceutical warehousing. |
Stage 9: Verification — in your hands
Every bottle carries a LOT number. Enter it on Verify Your Batch and you will see this exact batch’s documentation — production date, expiry, and certificates as they are published. The whole chain above exists so that this last step means something: you should not have to take our word for anything on this page. How to read a Certificate of Analysis — GMJ News.
Regulatory references on this page: EU Reg. 178/2002 (general food law, traceability); EU Reg. 852/2004 (hygiene, HACCP); EU Reg. 1935/2004 & 10/2011 (food-contact materials); EU Reg. 2023/2006 (GMP); EU Reg. 1169/2011 (food information); ICH Q3D (R2) (elemental impurities); Ph.Eur. 5.1.8 (microbiology); Codex Alimentarius CXC 1-1969 (HACCP); ISO 22000:2018; ISO/IEC 17025; WHO guidance on substandard and falsified products. Georgian Food/Feed Safety Code — National Food Agency state control. Certificate copies: info@accreditation.ge · WhatsApp.
