Verification & release
Quality & Compliance
Quality management, analytical capability, third-party retesting and batch traceability.
01 / Verification path
Five steps from inquiry to a batch you can defend.
This is the sequence we run with every new customer. Each step produces a document you keep.
Specification agreed in writing
Product, purity target, test methods, water and counter-ion limits, packaging, quantity. Signed before production, not after.
Sample with a matching COA
The sample and the COA come from the same lot. Sample policy: [PLACEHOLDER: sample size and cost].
Your independent retest
You nominate the laboratory. We supply the specification, method parameters and reference information. If results disagree, both labs work from retained material of the same batch.
Batch release with the full document pack
COA, TDS, SDS, declarations and the batch record summary ship with the goods — not weeks later on request.
Retained sample and audit access
Retention [PLACEHOLDER: months]. Remote document review or on-site audit by appointment.
02 / Quality system
The parts of a QMS that affect your batch.
Most quality pages list standards. Buyers care about mechanisms: who can release, what happens when a result is out of specification, and how a change reaches the customer.
| Element | What it controls | Record |
|---|---|---|
| Document control | Versioned specifications, methods and batch records | SOP index |
| Batch record review | Every production step signed before release | Batch record |
| Deviation handling | Any departure from the process is recorded and assessed | Deviation log |
| OOS investigation | Out-of-specification results trigger a documented investigation before retest | OOS report |
| Change control | Process, supplier or method changes are assessed and notified | Change notice |
| CAPA | Root cause and corrective action tracked to closure | CAPA log |
| Training | Analysts and operators qualified for the methods they run | Training matrix |
| Supplier qualification | Raw material and packaging suppliers approved and audited | Approved supplier list |
- Certified to
- [PLACEHOLDER: ISO 9001?]
- Certificate no.
- [PLACEHOLDER]
- Valid until
- [PLACEHOLDER]
- Last audit
- [PLACEHOLDER: date / scope]
- Release authority
- [PLACEHOLDER: role]
Until a certificate is in hand, this box stays as a placeholder. A claim of certification is one of the first things a serious buyer will check.
03 / Analytical capability
What we measure, and with what.
Each test exists to catch a specific failure mode. If a parameter is missing from a COA, ask which failure mode is left unmeasured.
| Technique | Measures | Catches | Instrument |
|---|---|---|---|
| RP-HPLC (UV 214 nm) | Purity, impurity profile | Deletion sequences, oxidation, diastereomers | [PLACEHOLDER: model] |
| LC-MS (ESI) | Molecular mass, identity | Wrong sequence, missed coupling | [PLACEHOLDER: model] |
| Karl Fischer | Water content | Hygroscopicity, mass-balance errors | [PLACEHOLDER: model] |
| Ion chromatography | Counter-ion (acetate, TFA, chloride) | Salt-form drift, peptide content shortfall | [PLACEHOLDER: model] |
| ICP-MS | Heavy metals, elemental impurities | Catalyst residues, raw-material contamination | [PLACEHOLDER: model] |
| GC (headspace) | Residual solvents | Purification and drying residues | [PLACEHOLDER: model] |
| SEC / GPC | Molecular-weight distribution | Incomplete hydrolysis or aggregation | [PLACEHOLDER: model] |
| Amino acid analysis | Composition | Sequence composition errors in hydrolysates | [PLACEHOLDER: model] |
| Microbiology | TPC, yeast & mould, pathogens | Contamination during drying and filling | [PLACEHOLDER: method] |
Method transfer
Full method parameters are in the TDS so your laboratory can reproduce the run.
Third-party testing
We ship retain samples directly to a laboratory you nominate. Shared-cost arrangement: [PLACEHOLDER: policy].
Stability studies
Real-time and accelerated data support the assigned shelf life. Protocols: [PLACEHOLDER: availability].
04 / Traceability
One batch number, one chain of records.
From raw material lot to your receiving bay, every step is linked to a batch number that appears on the drum, the COA and the invoice.
| Batch number format | [PLACEHOLDER: product code + year + sequence] |
| Linked records | Raw material lots · synthesis record · purification fractions · QC results · release signature · shipping documents |
| Retained sample | [PLACEHOLDER: quantity and retention period] |
| Record retention | [PLACEHOLDER: years] |
| Recall procedure | [PLACEHOLDER: procedure reference] |
Certificates are maintained under Appearance → Customize → Certifications, so a single update changes every page.
Due diligence
Request a specimen COA and the document list.
Send your specification and we answer point by point — including the points we cannot meet.