Documentation & Quality Pack
The honest way to assess a supply partner is not the logo on the quotation — it is the paperwork that arrives with the goods. This page sets out exactly what documentation accompanies a PharmaTradz shipment, at which stage you receive it, and what it lets you verify independently.
Why we publish this
A buyer sourcing across borders is being asked to trust a company they have not met, for goods they cannot inspect, from a factory they have not audited. That is a reasonable thing to be cautious about, and vague reassurance does not solve it.
What does solve it is documentation you can verify without taking our word for anything. A GMP certificate can be checked against the issuing regulator. A CoPP can be validated through the exporting authority. A batch number on a Certificate of Analysis can be matched to the physical consignment. Regulatory approvals are matters of public record.
So rather than asking you to trust us, we tell you precisely what you will be able to check.
Independently verifiable
- GMP certificate — verifiable with the issuing regulator
- CoPP — verifiable with the exporting authority
- Manufacturing licence number — public record
- CoA batch number — matchable to the physical goods
- Regulatory inspection status — published by most authorities
- Pre-shipment inspection — by an agency you nominate
What the pack contains
| Document | What it proves | When you get it |
|---|---|---|
| Certificate of Analysis (CoA) | Test results for the exact batch supplied, against the finished product specification, traceable to batch number and manufacturing date | Before shipment; original travels with the consignment |
| GMP certificate | The manufacturing site is currently assessed as compliant by a named regulatory authority | At quotation stage on request |
| Manufacturing licence | The site is licensed to manufacture that dosage form in its home jurisdiction | At quotation stage on request |
| Certificate of Pharmaceutical Product (CoPP) | Regulatory standing of the product in the exporting country, in WHO-recommended format | Where the destination regulator or tender requires it |
| Finished product specification | The acceptance criteria the batch was released against | With the technical pack, pre-order |
| Method of analysis | How each test was performed, so your QA can reproduce it | With the technical pack, pre-order |
| Stability data summary | Justification for the assigned shelf life and storage condition | With the technical pack, pre-order |
| TSE/BSE statement | Absence or controlled origin of ruminant-derived material | With the technical pack; required for many markets |
| Residual solvent & elemental impurity statements | Compliance with applicable ICH thresholds | On request with the technical pack |
| Material Safety Data Sheet (MSDS/SDS) | Handling, storage and transport safety information | With the technical pack |
| Artwork, label and insert proofs | Exactly what will be printed, for your approval before production | Before production begins |
| Certificate of origin | Country of manufacture, for customs and duty purposes | With shipping documents |
| Packing list & commercial invoice | Consignment contents, batch split, quantities and values | With shipping documents |
| Temperature record | Continuous data-logger record for cold-chain and controlled-temperature goods | On delivery, for temperature-sensitive shipments |
Exact composition varies by product type and destination market. Additional documents such as Free Sale Certificate, Product Quality Review, SmPC, Certificate of Conformity or GS1 labelling files are provided where the market or programme requires them.
What you receive at each stage
1. Enquiry
Country of manufacture, regulatory approvals held, certification mix (WHO-GMP, EU-GMP, PIC/S, US FDA), pharmacopoeial standard, available strengths and pack presentations, indicative lead time.
2. Technical evaluation
GMP certificate, manufacturing licence, finished product specification, method of analysis, stability summary, TSE/BSE statement, specimen CoA and MSDS. Site identity disclosed where a CDA has been agreed.
3. Order confirmation
Manufacturing site written into the contract, artwork and label proofs for approval, agreed Incoterm and payment instrument, CoPP process initiated where required, pre-shipment inspection agency agreed.
4. Shipment
Batch-specific CoA, certificate of origin, packing list, commercial invoice, legalised CoPP where applicable, inspection report, and temperature record for controlled-temperature goods.
How to read a Certificate of Analysis before you clear customs
A CoA is only useful if it is checked. These are the points our own QA review looks at, and we recommend your team applies the same list to any supplier, including us.
- Batch number matches the physical cartons and the packing list
- Manufacturing and expiry dates give you the residual shelf life you contracted for
- Pharmacopoeial reference is the one you require — USP, BP, EP or IP are not interchangeable
- Every specification line has a result, not "complies" against a blank
- Assay value sits comfortably inside limits, not at the very edge
- Related substances and impurities are individually reported, not summarised
- Dissolution profile is present for solid orals, with the medium stated
- Signed and dated by a named, qualified person at the manufacturing site
Straight answer on supplier identity
We do not publish our manufacturer list on this website. That is a deliberate commercial decision and we would rather state it plainly than let you discover it after an enquiry.
The reason is straightforward: identifying the right manufacturer for a specific market, dosage form, regulatory pathway and volume is the work we actually do. It involves consulting multiple sites, checking real capacity and approvals against your requirement, and negotiating terms. A published list would let that work be taken and used without us — and we would stop being able to do it for anyone.
What that does not mean is that you buy blind:
- Regulatory approvals, certifications and country of manufacture are shared at enquiry stage, with no agreement needed.
- Where a requirement is firm and specific, manufacturer disclosure under a confidential disclosure agreement can be arranged on request. We consider these case by case.
- Under a CDA you evaluate the named site and its full technical file before committing.
- For public tenders the site and its file are disclosed in the bid, because the tender board requires it.
- You may nominate your own pre-shipment inspection agency at any point.
We assess CDA requests individually rather than issuing them automatically — a serious buyer with a defined requirement is a different proposition from a general information request, and treating both the same would not be fair to the manufacturers who work with us. Tell us the molecule, market and volume you are working on and we will tell you what we can share and on what basis.
Standards and approvals across our source network
Not every source holds every approval. The approvals relevant to your product and destination are confirmed in writing at quotation stage, and the certificates themselves are supplied for verification.
Want to see the pack for a specific product?
Tell us the molecule, dosage form and destination market. We will confirm which approvals the available sources hold and what documentation you would receive — before you commit to anything.
Request Documentation Pack Ask a question first