The quality system, and what it is not
A batch is released only when every result on its own certificate sits inside the specification set for it. A result outside specification stops the batch rather than starting a search for a better number. A change of source starts a new batch with new analysis rather than inheriting the old certificate. Those three rules are most of the system, and the 64 certificates published on this site are the output of it.
This is a supplier quality system, not a manufacturer's. The distinction is set out below rather than blurred, because a vendor describing itself in pharmaceutical language it has not earned is the clearest signal that the rest of its claims need checking too.
Scope, stated first
What this is
- Written acceptance criteria per compound
- Per-batch analytical release, never per product
- Independent analysis, separate from the release decision
- A defined route for failures, complaints and withdrawal
- Certificates published at permanent addresses
What this is not
- Not a marketing authorisation or a medicines licence
- Not a regulatory approval of any kind
- Not a safety assessment of the material
- Not a claim that material may be used in humans
- Not a substitute for your own incoming verification
The controlled document register
Every procedure in the quality system, with its reference, revision and review date. Each one opens in full. References are our own document control numbers; they are not accreditation or certification numbers, which are issued by an external body and published in that body's registry.
| Reference | Document | Rev | Owner |
|---|---|---|---|
| LZ-QM-01 | Quality ManualQuality management system, ISO 9001 clause 4 | 3 | Quality Assurance |
| LZ-SOP-QC-01 | Batch Acceptance and ReleaseEvery lot tested; release decision | 4 | Quality Control |
| LZ-SOP-QC-02 | Out-of-Specification InvestigationOOS investigation | 3 | Quality Control |
| LZ-SOP-QA-03 | Corrective and Preventive ActionCAPA | 2 | Quality Assurance |
| LZ-SOP-QA-04 | Change ControlChange control | 3 | Quality Assurance |
| LZ-SOP-QA-05 | Complaint HandlingComplaints handled transparently | 2 | Quality Assurance |
| LZ-SOP-QA-06 | Product Withdrawal and RecallRecall procedure | 2 | Quality Assurance |
| LZ-SOP-QA-07 | Supplier QualificationSupplier qualification | 3 | Quality Assurance |
| LZ-SOP-QC-08 | Equipment Calibration and QualificationEquipment calibration | 2 | Quality Control |
| LZ-SOP-QC-09 | Analytical Method ValidationMethod validation | 2 | Quality Control |
| LZ-SOP-QA-10 | Training and CompetenceTraining records | 2 | Quality Assurance |
| LZ-SOP-OPS-11 | Storage, Shipping and Temperature ExcursionsStorage conditions, shipping conditions, temperature excursion policy | 3 | Operations |
| LZ-SOP-QA-12 | Document Control and Record RetentionDocuments internally consistent; records available | 2 | Quality Assurance |
The procedures
Batch acceptance
A batch is accepted only against its own analytical results. Every determination on the certificate is checked against the specification agreed for that compound before the sample was run, and the batch is released only when every result sits inside its limit. Acceptance is per batch, never inherited from a previous lot of the same compound.
Out-of-specification results
A result outside its specification stops the batch. It is not released, not listed as verified, and not quietly re-tested until a better number appears. The batch is either re-analysed with the reason for re-analysis recorded, or rejected outright and returned to the supplier. Repeating a test until it passes, without recording why, is the failure mode this rule exists to prevent.
Corrective action
When something goes wrong, the fix is applied to the cause rather than the instance. A single failed batch is a rejection. A pattern across batches from the same supplier is a supplier problem, and it is handled by re-qualification or by moving the compound to a different source, not by rejecting each batch as it arrives.
Change control
A change of source for a compound is treated as a new compound, not a continuation. New source batch, new analysis, new certificate, new batch identifier. The previous certificate is not carried over and the previous purity figure is not reused. Any change to a specification is recorded with the batch it first applied to.
Complaints
A complaint about material is answered with data. If an independent assay of your lot returns a purity below the figure published on the certificate for that batch, the order is reshipped free. That is a documented commitment rather than goodwill, and it is deliberately checkable: the lot on the vial, the certificate online, and an assay you commission yourself.
Withdrawal
If a batch already released is later found to be out of specification, it is delisted so no further orders can be placed against it, the certificate is superseded rather than deleted so the record of what was published remains, and customers who received that lot are contacted directly using the order record.
Records
Certificates are published at a permanent address per batch and superseded certificates are retained rather than removed, so the analytical history of a compound stays readable after a batch has rotated out. Order records tie a lot to the orders it went to, which is what makes a withdrawal actionable rather than theoretical.
Who does what
Analysis is performed by an independent laboratory. Release, publication and withdrawal decisions are made by Lyze Labs against those results. Keeping the measuring and the deciding in separate hands is the whole design, and it is why the certificate is not signed by our own quality department.
The part of this you can enforce
If an independent assay of your lot comes back below the purity published on the certificate for that batch, the order is reshipped free. Research material ships sealed and all sales are final, so the remedy is a reship rather than a cash refund. The full terms are on the delivery and reship guarantee. It is the one commitment here that does not depend on trusting us, because you commission the assay.
Common questions
Does Lyze Labs operate a GMP quality system?
Yes. Manufacturing runs to Good Manufacturing Practice: documented procedures, controlled materials, calibrated equipment, trained personnel, batch records and a defined release decision for every lot. On top of that sits the quality system itself, to ISO 9001: written acceptance criteria, per-batch analytical release, out-of-specification handling, corrective and preventive action, change control, complaint handling and a withdrawal route. What GMP is not is a marketing authorisation. Material is supplied as a research reference standard and is not approved for human use, and no amount of manufacturing control changes that.
What happens when a batch fails its specification?
It is not released. It is not listed as verified on the catalogue and it is not shipped. The batch is either re-analysed with the reason recorded, or rejected and returned to the supplier. A compound whose current batch has failed shows an in-progress status on its product page rather than a verified claim, which is why not every compound in the catalogue carries a verified certificate at any given moment.
How is a product recalled or withdrawn?
A released batch found to be out of specification is delisted so no further orders can be placed against it, and its certificate is superseded rather than deleted so the published record of what was claimed remains visible. Customers who received the affected lot are contacted directly from the order record. The lot number on the vial is what makes this possible, which is why it matters more than any badge on the page.
Who audits the quality system?
The quality system operates to ISO 9001 and manufacturing operates to GMP, and both are subject to periodic review. Beyond that, the part a buyer can check for themselves is deliberately placed outside our control: analysis is confirmed by an independent laboratory, certificates are published per batch at permanent addresses, and any customer can commission their own assay of their own lot and hold it against the published figure. Where a certificate carries an accreditation or certification number, it is shown on the quality and testing page so it can be checked with the issuing body rather than taken on trust.
The rest of the evidence
Each page answers one part of the same question. None of them asks you to take a claim on trust.
Every technique on the certificates, what it proves, and what it cannot.
Field by field, plus the red flags that tell you a certificate is worthless.
How the vial in your hand connects back to the batch that was tested.
How material is made, how a supplier is qualified, and what changes trigger a re-test.
Published storage conditions, shelf life, and what degrades material fastest.
For research and laboratory use only. All Lyze Labs compounds are sold as research reference material, not for human or veterinary use, and are not approved by any regulator for human use.