GMP-aligned from batch start to CoA
Each production run follows a documented quality system.
GMP alignment for small-batch production
Each batch follows documented SOPs, scheduled equipment calibration and maintenance, with every deviation from specification recorded and reviewed before shipment.
Leumas uses dosage-form-specific SOPs, controlled cleanrooms with documented environmental monitoring, and calibrated filling and testing equipment maintained on schedule.
-
CLASS 100,000 cleanroom
Capsule filling takes place in a controlled cleanroom with continuous particle monitoring.
-
Separate powder room
A dedicated powder blending area limits cross-contamination between dosage form types.
-
Temperature-controlled storage
Raw materials and finished goods stay in temperature-monitored storage with continuous logging.
Batch testing protocols
Before release, each batch follows a defined testing protocol. In-house checks cover weight and disintegration, while third-party laboratories provide certificates for potency assay, microbial limits, and heavy metals.
- Identity testing for active ingredients
- Potency assay by HPLC for select vitamins
- Microbial limits: TAMC, TYMC, coliforms
- Heavy metals: lead, arsenic, mercury, cadmium
- Disintegration and dissolution testing
- Moisture content measurement
Automated quality checks
The scheduling system tracks in-process weight data throughout each run. Checkweigher readings are collected every 15 minutes and plotted on per-batch SPC charts. Readings outside tolerance automatically pause the line and create a logged deviation requiring human review before production resumes.
Continuous monitoring identifies weight drift before a full run accumulates out-of-spec units. SPC charts become part of the batch record and the documentation package sent to the brand.
Weight check interval during each production run
Batch QC pass rate across our first 15 production batches
What brands receive
Each batch ships with a complete documentation package in PDF and structured data export formats for records management.
Production record covering in-process steps, operator sign-offs, and equipment readings for the run.
Third-party test results for identity, potency, microbial limits, and heavy metals where applicable to the formula.
Supplier certificates trace each active ingredient from raw material lot to finished batch.
Any production deviation includes a signed deviation log, investigation summary, and disposition decision.
Contact our quality team
Questions on testing protocols, GMP documentation, or export compliance requirements? Email our quality team or submit a request through the contact form.