cGMP Quality Standards & ISO/IEC 17025 Laboratory Auditing
Gelagen is produced under strict quality control standards exceeding baseline dietary supplement industry benchmarks. Every single production batch is compounded inside a domestic manufacturing facility registered with the US Food and Drug Administration (FDA) that strictly adheres to Current Good Manufacturing Practices (21 CFR Part 111).
Third-Party ISO 17025 Testing Protocol
Prior to commercial warehouse release, random production samples undergo comprehensive analytical verification by Norfield Analytical Laboratories, LLC, an independent contract laboratory accredited under international ISO/IEC 17025:2017 standards:
- Heavy Metal Screening (ICP-MS): Samples undergo microwave acid digestion and inductively coupled plasma mass spectrometry to verify that Lead, Mercury, Cadmium, and Arsenic are below stringent USP <2232> limits.
- Active Marker Quantification (HPLC): High-performance liquid chromatography confirms that pure D-biotin and co-vitamins meet or exceed 100% of declared label claims (Batch GLG/26-1184-B confirmed at 101.4% potency).
- Microbiological Pathogen Challenge: Plating protocols verify the total absence of Salmonella species, E. coli, and dangerous mold or yeast counts under USP <2021> and <2022>.