Quality Assurance
Our Commitment to Excellence — Every vial. Every batch. Every time.
The Four Foundations of Our Quality
Every Biomedica product is built on four non-negotiable quality pillars that apply to every compound, every batch.
GMP Compliance
All products manufactured under Good Manufacturing Practice guidelines with validated procedures, documented controls, and qualified personnel.
Sterile Manufacturing
Fully sterile production environment with validated aseptic processing, 0.22-micron filtration, and microbiological environmental monitoring.
HPLC Batch Testing
High-Performance Liquid Chromatography verification of compound identity, purity (≥98%), and concentration accuracy (±5% of label claim) on every batch.
Certificate of Analysis
A complete Certificate of Analysis with all test results, specifications, and batch documentation is issued for every production lot prior to distribution.
Manufacturing Process
From raw material sourcing to final authentication code assignment — every step is documented and controlled.
Raw Material Sourcing & Identity Verification
Every raw material is tested for compound identity and purity before entering the production area. Materials failing identity testing are quarantined and rejected without exception.
Synthesis & Pharmaceutical Compounding
Compounds are formulated using validated procedures in controlled environments. Pharmaceutical-grade carrier oils, solvents, and bacteriostatic agents are used exclusively.
Quality Control — Purity & Concentration Testing
In-process and final HPLC analysis confirms compound identity (≥98% purity) and concentration accuracy (±5% of label claim) before proceeding to sterile filtration.
Sterile Filtration & Endotoxin Testing
All injectable formulations are sterile-filtered through validated 0.22-micron membranes. Filter integrity testing is performed before and after each filtration. Endotoxin levels are verified by LAL assay (<0.25 EU/mL).
Vial Filling & Crimping Under Aseptic Conditions
Final filling and sealing operations are performed under aseptic conditions with environmental monitoring. Each vial undergoes 100% visual inspection for particulate matter and container integrity.
Final Inspection, Labeling & Authentication Code Assignment
Completed vials receive batch-specific labeling and a unique authentication code is assigned to each unit. The authentication code is registered in our verification database before product release.
Release Testing Parameters
Every production lot must pass all of the following tests before release for distribution.
| Test Parameter | Method | Specification | Status |
|---|---|---|---|
| Compound Identity | HPLC / MS | Confirmed match to reference standard | ✓ Required |
| Concentration Accuracy | HPLC-UV | ±5% of label claim | ✓ Required |
| Purity | HPLC-UV | ≥98% | ✓ Required |
| Sterility | USP <71> | No growth (14-day incubation) | ✓ Required |
| Bacterial Endotoxins | LAL Assay | <0.25 EU/mL | ✓ Required |
| Particulate Matter | USP <788> | Passes visual and instrumental inspection | ✓ Required |
| pH | Potentiometry | 5.0 – 7.5 | ✓ Required |
| Container Integrity | Visual / Leak Test | No cracks, leaks, or stopper defects | ✓ Required |
Product Authentication System
Every Biomedica product is assigned a unique authentication code during the final stage of production. This code is printed on the outer packaging and is registered in our secure verification database.
Customers can verify the authenticity of any Biomedica product instantly by entering the code on our Authentication page. A genuine Biomedica product will return a confirmation of originality; a counterfeit will return a negative result.
This system allows our clients to independently verify what they receive without relying solely on our assurances — full transparency, by design.
Verify a Product NowCertificate of Analysis
Every production lot ships with a complete Certificate of Analysis documenting all release test results.
Batch Identification
Unique batch number, production date, and compound name linking the COA to the specific production lot.
Analytical Test Results
Complete HPLC results for identity, purity, and concentration with chromatographic data and pass/fail determinations.
Microbiological Results
Sterility test outcome, endotoxin quantification results, and environmental monitoring data from the production batch.
Specifications Reference
Full listing of acceptance criteria for each test parameter, enabling direct comparison against results.
Packaging & Storage
Confirmed container/closure system integrity results and recommended storage conditions for the compound.
Authentication Reference
Authentication code range assigned to the batch for cross-reference with the product verification database.