Five-Stage Production Method
Specification Definition
Every formulation begins with a written compositional specification. The document records each ingredient, its target quantity per serving, the acceptable variance range, the ingredient form (e.g., chelated bisglycinate vs. oxide), and the justification for inclusion drawn from published nutritional research.
The specification is version-controlled with a revision number. Changes between revisions — whether triggered by new reference data or sourcing constraints — are documented in a formal change record that is permanently attached to the specification file.
Supplier Qualification
Active ingredients are sourced from documented suppliers, with each batch accompanied by a certificate of composition. Sourcing prioritises suppliers whose facilities maintain food-grade processing standards.
Prospective suppliers undergo a qualification review that evaluates their documentation chain: incoming material records, processing environment standards, and the completeness of their certificate-of-composition process. Approved suppliers are logged in the Orbano supplier register with a qualification date and renewal interval.
Incoming Material Analysis
On receipt of each material delivery, a sample is drawn from the incoming lot and submitted for elemental and identity analysis. The analysis report is cross-referenced with the supplier's certificate of composition before the material is approved for production use.
Material that does not meet the specification variance range is quarantined and returned to the supplier. The quarantine event is recorded in the lot record with the specific out-of-specification parameter identified.
Production Oversight
Production batches are run against the approved specification. Blending ratios, encapsulation weight targets, and capsule fill consistency are monitored throughout the production run. In-process samples are retained for the lot record.
The production documentation package — covering blend records, encapsulation log, and in-process sample results — is compiled and reviewed against the specification before the batch proceeds to the third-party verification stage.
Third-Party Verification
Each completed batch is submitted to an independent third-party laboratory for finished-product elemental analysis. The laboratory tests the finished capsule against the declared specification, producing a verification report that is held in the batch archive alongside the production documentation package.
Units are not released for distribution until the third-party verification report has been received, reviewed against specification tolerances, and formally accepted. The acceptance record is signed and date-stamped as the final entry in the lot record.
