Sourcing IVD Raw Materials Without a GMP Certificate

Updated 2026-09-28

Not every supplier holds GMP. These are the questions that separate a capable raw-material supplier from one whose paperwork will not hold up.

Understand What You Are Buying

Many suppliers of research and IVD-development raw materials do not hold GMP manufacturing certification, and the absence of GMP is not by itself disqualifying. GMP status describes a manufacturing framework, not the quality of a specific lot. What matters is whether the material is fit for purpose and whether its quality can be demonstrated and maintained. Check the stated intended use, the release testing and the lot-to-lot consistency. A clear answer about limitations is more useful than a vague assurance of quality. A supplier who can describe the process clearly is often more informative than a certificate alone.

Questions to Ask Before Ordering

Ask what the material is intended for, whether it is produced under any formal quality system, and how lot release is defined. Ask how identity is confirmed and which method is used for purity. Ask whether a Certificate of Analysis accompanies each lot and what it contains. Ask how changes to the manufacturing process are communicated, and whether historical lot data or retention samples are held. Ask about stability data and the recommended storage and shipping conditions. The answers show how well the material is controlled.

What Documentation Should Accompany the Material

A practical pack includes a lot-specific Certificate of Analysis, a material safety data sheet where applicable, and a datasheet describing handling, storage and reconstitution. For cross-border shipment, documents such as a commercial invoice, packing list and certificate of origin may also be required. Confirm before ordering which documents the supplier can provide and in which format, because obtaining them after dispatch is slow. Treat documentation as part of the product specification rather than an afterthought.

What to write into the agreement, not just the purchase order

Absence of GMP certification is not disqualifying, but it does move the burden of definition onto you, and the place to carry it is a written agreement rather than an email thread. Set out the specification the material must meet, naming the method for each parameter so the requirement is testable. Set out the documentation that accompanies each lot and the format you need it in. Set out the notification period for changes to the manufacturing process or to a subcontractor, and the circumstances in which you would expect the material to be requalified. Set out what happens on non-conformance: whether you receive a replacement, an investigation, or both. None of this requires the supplier to hold a certification you do not need; all of it requires them to be specific, which is a fair test of the organisation you are buying from.

Change control is the question nobody asks until it is expensive

The cost of an unannounced process change is not the material itself but every experiment that depended on the previous version of it. That is why the useful question is not whether a supplier has a quality system but whether a change to the process would reach you before it reached your assay. Two practical protections are available to any laboratory. Ask at the outset whether historical lots are retained and for how long, since a retained lot is what allows a discrepancy to be investigated rather than merely noticed. And ask how a process change is communicated — a notice, a new lot number with a note, or nothing at all. Suppliers who serve regulated industries answer these questions routinely. Suppliers who cannot answer them are telling you something about what will happen the first time their process moves.

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