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ISO 13485 • GMP • FDA

Quality & Compliance

We manufacture supplements with a documentation-first quality system built for consistency, safety, and repeatability. From qualified sourcing and incoming inspection to controlled production and batch release, every run follows traceable records.

View certificates Explore our controls
Certified & compliance-minded operations We hold the following certificates: ISO 13485, GMP – Good Manufacturing Practices, and FDA.
ISO 13485 GMP FDA

Our quality system, end-to-end

We apply practical controls that reduce variability and support audits, investigations, and long-term supply reliability. Quality is built into the process—not inspected in at the end.

Supplier qualification

We work with defined specifications and qualified suppliers to support consistent, predictable inputs.

Incoming inspection

Each delivery is checked for labeling, lot/expiry, documentation, and visual condition before it enters production.

Hygienic production design

Cleanability and sanitation are built into workflows. Where applicable, product-contact surfaces use stainless steel 316.

Process control

Documented parameters (mixing, fill weights/volumes, line clearance) help keep batch output consistent.

Documentation & traceability

Batch records and lot tracking support fast, targeted investigations and confidence in every shipment.

Corrective actions

We investigate root cause, apply corrective actions, and update procedures to prevent recurrence over time.

Controls we apply in practice

Below are the controls typically applied across supplier management, manufacturing, packaging, and release—focused on repeatability and audit readiness.

Supplier & material management Before production
  • Raw material specifications and supplier qualification.
  • Incoming inspection: labels, lot/expiry, documentation (e.g., COA), packaging integrity.
  • Controlled storage and clear identification to prevent mix-ups.
  • Nonconformance handling: hold/quarantine and documented resolution.
Production environment & equipment Hygiene & repeatability
  • Sanitation routines and line clearance between products and batches.
  • Product-contact equipment designed for cleanability; stainless steel 316 where applicable.
  • Preventive maintenance planning to reduce downtime and variability.
  • Controlled tools and measuring devices supporting accurate fills.
In-process checks During manufacturing
  • Verification of critical steps (weighing, mixing/blending, time/temperature targets).
  • Fill control: weight/volume checks at defined intervals with documented results.
  • Packaging component checks (label version, barcode, lot coding).
  • Deviation capture and resolution to keep runs controlled and auditable.
Finished goods & release Before shipment
  • Batch record review for completeness and adherence to specifications.
  • Packaging integrity checks (seal/cap/closure) and final label verification.
  • Controlled release process: only approved goods are shipped.
  • Traceable lot codes for fast, targeted investigations if required.

Quality checkpoints across a batch

A typical flow of checkpoints from incoming materials to released finished goods—designed to keep outcomes consistent and documentation complete.

1
Material receipt & identification

Verify supplier docs, labeling, lot numbers, and incoming condition. Materials are identified and controlled before use.

COA/docsLot trackingQuarantine/hold
2
Weighing & preparation

Materials are weighed against the batch record and prepared with clear identification to prevent mix-ups.

Batch recordDouble-checksLine clearance
3
Manufacturing / blending

Controlled parameters guide mixing, temperatures, and processing steps—documented for repeatability.

Process parametersIn-process checksDeviation capture
4
Filling & packaging

Fill weights/volumes are monitored; packaging components are verified to ensure the right label, pack, and lot code.

Fill controlLabel checksSeal integrity
5
Final review & release

Batch documentation is reviewed and only conforming finished goods are released for shipment.

Record reviewRelease decisionTraceability
6
Retention & support

Documentation and retained information support audits, investigations, and continuous improvement.

Audit readinessCAPAContinuous improvement

Want to review our compliance approach for your product?

Share your format (gummies, capsules, liquids, powders, pouches, syrups) and target volumes. We’ll outline a production plan and the quality documentation you can expect—aligned with ISO 13485, GMP, and FDA requirements.

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