NOVA Q BIOSCIENCES LLC, DBA NOVA Q Research. All materials are supplied for laboratory and scientific research use only, not for human or veterinary use. This policy governs product quality; it does not authorize or contemplate any human or animal use of the materials.
1. Purpose and scope
This policy defines how NOVA Q Research assures the quality, identity, and traceability of the research-use-only (RUO) reference materials it supplies, and how it manages any product quality event, including recall or withdrawal. It applies to all products, all lots, and all personnel and contractors involved in sourcing, verification, labeling, fulfillment, and customer support.
2. Quality standards and sourcing
- Materials are procured from vetted third-party manufacturers operating to GMP or GMP-equivalent standards.
- Each purchase order states written quality requirements: lyophilized presentation, confirmed fill weight, unique lot numbering, RUO labeling, and a lot-specific Certificate of Analysis (COA) from independent third-party testing.
- NOVA Q does not manufacture or compound materials and is not a 503A or 503B facility.
3. Incoming lot verification and testing
- Every lot is verified by independent, third-party laboratory testing before release for sale.
- Testing covers identity (mass spectrometry), purity (HPLC), and, as applicable, endotoxin and sterility screening.
- A lot-specific COA is retained for every lot and named to the testing laboratory. COAs are not reused across lots.
- Each lot COA is made available to customers through the on-site, QR-linked lot-verification tool.
- A lot that fails verification is not released and is quarantined under Section 5.
4. Lot traceability and records retention
- Each lot carries a unique, traceable lot number. Records link every lot from supplier and manufacturing origin through incoming verification, inventory, and each sale.
- Records are maintained in the company CRM/ERP with traceability to the purchasing researcher of record.
- Quality records are retained for no less than five years.
5. Product recall and withdrawal plan
A recall or withdrawal may be triggered by a failed or retracted COA, a credible quality or contamination concern, a supplier notification, or a regulatory communication. The Managing Member (or a designated Recall Coordinator) owns the response.
- Identify. Determine the affected lot numbers and the full distribution list from the ERP records.
- Quarantine. Immediately place remaining affected inventory on hold and stop its sale and shipment.
- Notify. Contact all customers who received an affected lot with the lot number, the reason, and clear return or disposal instructions, promptly and in writing.
- Correct. Investigate root cause, document findings, and implement corrective and preventive action.
- Record. Log the event, actions, communications, and outcome.
6. Loss control and risk management
- Every product carries the RUO warning with no dosing, treatment, or human-benefit content.
- Purchasers must be 21 or older and complete a research-use attestation at checkout; NOVA Q reserves the right to decline non-qualified buyers.
- All sales are governed by the published Terms and Conditions, including assumption of risk, warranty disclaimer, limitation of liability, indemnification, and no-resale provisions.
- Customer quality complaints are logged, investigated, and escalated to the recall procedure where a quality event is confirmed.
7. Sales and marketing conduct standards
- All product content and marketing describe materials strictly as RUO reference materials, with no claim of therapeutic effect, dosing, human or animal use, or disease treatment.
- Personnel and contractors involved in content, sales, or support are trained on these standards at onboarding and at least annually.
8. Governance and review
This policy is approved by the Managing Member and reviewed at least annually, or sooner following any material quality event or change in operations.