Quality System
Quality Control
Our quality control system is not a checklist—it is an integrated set of controls applied at every stage of production. Every batch must pass all controls before release. There are no exceptions.
Control Points
Incoming Material Inspection
All raw materials undergo identity testing (IR spectroscopy, HPLC) and purity assessment upon receipt. Materials are held in quarantine until approved by our QC team.
In-Process Controls
Analytical checks at multiple production stages. Weight verification, environmental monitoring, and equipment calibration logs maintained for every production run.
Finished Goods Testing
Every finished batch sampled and tested for identity, purity, and absence of contaminants before submission to third-party analysis.
Third-Party Analysis
ISO 17025-accredited laboratory confirmation of purity by HPLC. Mass spectrometry identity confirmation. Independent from our internal QC.
Stability Monitoring
Representative samples from each batch retained and tested at intervals throughout the stated shelf life. Expiration dates based on stability data, not assumptions.
Non-Conformance Management
Any batch failing to meet specification is quarantined, investigated, and destroyed. Root cause analysis and corrective action documentation required before resuming production.
