GMP Standards
Current Good Manufacturing Practice governs every gram we produce — from raw material intake through final release. Documented, audited, enforced.
The five pillars of GMP
Designed for compliance
- 01HEPA-filtered air handling with pressure cascades
- 02Epoxy-coated, coved floors — zero particulate traps
- 03Personnel & material airlocks at every zone change
- 04Real-time environmental monitoring (particle, RH, ΔP)
Cleanroom grades & permitted operations
The paper trail is the proof
From raw material to release
Nothing runs without qualification
Every facility, utility, instrument and process is qualified through a documented lifecycle — installation, operation, performance.
Trained before they enter
Every operator, technician and QA member completes structured GMP training with periodic reassessment and gowning qualification.
Live environmental parameters
Deviation & CAPA discipline
Every out-of-spec observation is logged, investigated, and closed with corrective and preventive action — never suppressed, never skipped.
Doors open, records ready
We do not prepare for audits. We operate so that any audit — announced or unannounced — finds us in the same state.
Public SOP & policy index
Request a compliance dossier
Partners and regulators can request our full compliance package — GMP certificates, site master file, and audit history.
Request dossier