Quality Control
Built Into Every Batch
Quality isn’t a final checkpoint, it’s a system. We quarantine and sample
every component, run 100% identity testing on dietary ingredients,
control the process in real time, and only release lots that meet full
specifications for identity, potency, composition, and safety.
Quarantine, Sample, Verify
- Every incoming component is quarantined and sampled per ANSI/ASQ Z1.4 or specification-defined criteria.
- Dietary ingredients receive 100% identity testing (FT-IR/FT-NIR, HPTLC, or compendial methods).
- We verify supplier CoAs, qualify vendors, and trend key attributes to spot drift before it becomes a deviation.
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Zoned Quarantine HoldsAllergens & other high-risk lots segregated -
Two-Scan ReceivingBarcode + PO match to prevent mix-ups -
Photographic Lot CaptureBox label & seal condition logged to batch record
Real-Time Controls Prevent Downstream Surprises
We monitor what matters:
- Blend uniformity by NIR or composite assay
- Moisture activity for stability and flow
- Line clearances verified with photo documentation
All checks are tied to electronic batch records; any deviation triggers structured investigation and CAPA.
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Stratified Blend SamplingRapid uniformity spot-test before manufacturing -
Real-Time SPC AlertsTrends ping QA before specs drift -
Capsule Net-Fill FeedbackReal-time weight control loop to hold RSD
Release Decisions Based on Full Spec Verification
Release isn’t a checklist, it’s a conclusion supported by data. We confirm: identity, potency, composition, and safety per the batch spec. Microbiological acceptance criteria are set by format and risk. When applicable, we confirm label claims via validated HPLC/UPLC or ICP-MS/LC-MS/MS methods.
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ISO-17025 Lab VerifiedThird-party lot quality validation -
Smart Retain PullsSized to dosage form for re-testing -
Dual-Authority Sign-offQA + Op approval, not just one gatekeeper
Meeting & Exceeding Global Standards
Analyses are performed using validated procedures and third-party confirmations. This ensures each result is scientifically defensible, reproducible, and aligned with international testing standards.
| Quality Specification | Why You Should Be Testing | Do We Test? |
|---|---|---|
| Rapid ID | Confirms material identity at receipt; detects mix-ups or substitutions for lot acceptance. | |
| CoA Verification | Verifies supplier results match approved specifications and critical attributes. | |
| Blend Uniformity | Assesses homogeneity; confirms even distribution of actives to support unit-dose consistency. | |
| Micro Panels | Quantifies total counts (bacteria, yeast/mold) and screens for specified pathogens to meet micro limits. | |
| Heavy Metals | Quantifies Pb, Cd, Hg, and As at ppb levels; compares against internal or regulatory limits. | |
| Residual Solvents | Measures Class 1–3 solvents and evaluates against ICH Q3C PDE limits. | |
| Pesticides | Screens multi-residue pesticide panels; flags results above action limits. | |
| Label Claims (Potency) | Quantifies stated actives (e.g., vitamins, botanicals, minerals) to confirm label claim at release. | |
| Stability | Determines change over time (potency, micro, physical); sets retest/expiry and storage conditions. |
Labels That Match The Product—Every Time
Before ink hits paper and long before a pallet ships, we verify that what’s on your label is accurate, compliant, and readable in the real world. Our packaging QA program pairs human expertise with vision systems to confirm claims, allergens, barcodes, lot/expiry print, color tolerances, and label placement on the line. The result is confidence—on the shelf, at receiving, and with your customers.
We don’t just proof PDFs; we govern the entire lifecycle—artwork intake, line clearance, in-run monitoring, and documentation at release—so every label says exactly what your product delivers.
What We Check
- Claims & Panels: Supplement Facts structure, required statements, storage/warnings, country of origin (as applicable).
- Allergens & Icons: Correct “Big 9” disclosures and any approved program marks (e.g., gluten-free, kosher) as provided.
- Barcodes: GS1 format and scan quality verified prepress; spot-checks post-print.
- Lot/Expiry & Legibility: Contrast and code sharpness validated on your specific substrate and color field.
- Placement & Orientation: Vision systems monitor presence, skew, and position at speed.
- Color Consistency: Tolerances defined from approved proofs; measured during first-article checks.
Quality Control FAQs
How do you handle OOS/OOE results?
We follow documented OOS procedure: immediate containment, hypothesis testing, confirmatory retest (if justified), root-cause analysis, CAPA, and effectiveness verification. Release is blocked until the investigation closes.
Can you run to my spec instead of your standard?
Yes. We’ll review your spec for scientific validity, align methods/LOQs, and bake it into your product file, batch record, and release criteria.
Do you accept supplier CoAs?
We verify supplier CoAs against approved specs and libraries; dietary ingredient identity is always tested per lot in our program.
What environmental controls are monitored?
Temperature, humidity, differential pressure, and low-RH suite controls—logged and alarmed 24/7. Data is trended and tied to CAPA when out of tolerance.
How long do you hold retains and records?
Retains: typically 2-3 year past expiry (or per contract). Records: per CFR Part 111 minimums and customer agreements.
Can you support a mock inspection?
Yes—document packages include SOPs, training records, batch records, CoAs, and deviation/CAPA history to support internal or external reviews.
Ready for a Clean, Defensible Release?
Share your formula, target market, and any retailer requirements. We’ll return a tailored control plan, sampling scheme, and test budget so you can move from pilot to production with confidence.
