Quality
The documentation your team receives
Every order is backed by the documents your quality, regulatory and import teams actually file, prepared to the standard your processes expect.
Good manufacturing is only half of what a buyer needs. The other half is paperwork: the batch-specific and product-specific records your quality, regulatory and customs teams rely on to release stock, complete a label and clear an import. Here is what your team receives from us and how each document supports your own market and import compliance. Each one below also has its own detailed explainer in our documentation section.
Certificate of Analysis, with every batch
The Certificate of Analysis is the batch-specific record showing how a produced lot actually tested against its agreed specification. It is the single document your quality team relies on to release, or reject, an incoming shipment, which is why it travels with every batch we ship rather than being offered only on request. Each lot can be checked, line by line, against the specification your team agreed.
The product and the exact batch or lot number it applies to
Each specification parameter, its acceptance limit and the measured result
The test method behind each result
Release status and the authorised signatory
Specification sheet, the agreed definition
The specification is the agreed definition of the product: the target values and acceptance limits that every Certificate of Analysis is then measured against. Agreeing it up front is what makes “in spec” mean the same thing to both sides. We prepare and share it at project setup and on request, so your regulatory and procurement teams can review exactly what will be produced before a single batch runs.
Declared actives and their target amounts
Physical properties and appearance
Purity and contaminant limits, including heavy metals
Microbiological limits
Packaging, storage conditions and shelf life
Allergen and GMO statements for your label
Two of the declarations your labelling and compliance teams need most feed directly onto the pack. The allergen statement declares which regulated allergens are, and are not, present in the product and on the line it is made on. The GMO statement records the genetically-modified-organism status of the ingredients. We state each only on the basis of formulation and supplier documentation, so a product is never labelled “non-GMO” or free from an allergen unless the ingredient data supports it.
Allergen: presence or absence of each regulated allergen, plus allergens handled elsewhere on the line and the cross-contamination controls in place
GMO: the status of each relevant ingredient, its basis, and the applicable market regulation
Traceability, from raw material to finished lot
Traceability is the ability to follow any finished lot back through its production history: the raw-material lots it was made from, their suppliers and country of origin, and the batch records at each step. It is what lets your team answer a customer query, a customs question or, in the worst case, a recall, quickly and with evidence. We provide it on request, covering the country of manufacture, the origin of the key raw materials, and the lot-level links that connect a shipment to the batch that produced it.
Safety Data Sheet, where applicable
A Safety Data Sheet sets out how to handle, store and transport a material safely, in the internationally recognised 16-section GHS format. Many finished dietary-supplement products do not require one, so we supply it where a material’s classification makes it relevant rather than as a matter of course. Where it applies, it covers identification, hazard classification, handling and storage, and transport information.
Export and market-access documentation
Beyond the per-batch and per-product records, we provide the export documentation that helps your team prepare its own market and importer compliance work. These are the records that support your import and customs process, arranged so your regulatory team can get on with its job rather than chase ours. The division of responsibility stays clean: we document what we manufacture, and your team handles registration and final release into your market.
Records that support your import and customs clearance
Documentation your regulatory team uses for its own market-access work
Prepared to the standard a supplier-qualification file expects
Together these documents let your quality, regulatory and customs teams work from evidence: release a batch, complete a label and clear an import, each backed by a record they can file. What we manufacture, we document, so market registration and final release stay firmly with you.
Verifiable quality, not adjectives
The standard
The independently audited GMP standard our facility is certified and publicly listed against.
Our approach
Identity checks, in-process controls, finished-product testing and full traceability, built into every batch.
Certifications
Each certification the facility holds, explained by what it covers and why a buyer should care.