Clinical Trial Supply Documents: CoA vs BRC vs SoA

Sponsors often request every quality document available when sourcing comparator medicines. That instinct is understandable, but it can slow sourcing, raise costs, and exclude optimal supply routes. This guide explains what a Certificate of Analysis (CoA), Batch Release Certificate (BRC), and Statement of Authenticity (SoA) each do, when they are typically needed, and how to set a need-versus-nice-to-have list with your QP and sourcing partner.

Why documentation shapes sourcing

Commercial medicines used as comparators must remain authentic, traceable, and suitable for the protocol. Documentation is how sponsors, Qualified Persons (QPs), and regulators gain that assurance.

Documentation also changes the sourcing map. Some markets routinely issue a CoA with wholesale stock, at a higher price. Others do not offer CoAs at all, such as Germany. Treating a CoA as mandatory in every case can exclude regions with better lead time or availability.

That is why documentation planning belongs next to product selection, not after it. Treat it as part of comparator drug sourcing strategy, alongside batch and expiry.

Statement of Authenticity (SoA)/Pedigree statement

An SoA (or pedigree statement) is a commonly provided document from a sourcing vendor. Terminology varies by vendor, but the role is similar.

A typical SoA confirms product description, batch number, licence details, expiry, and manufacturer or marketing authorisation holder. It also attests that the product was procured under applicable rules and stored under licensed conditions. For EU product, it may also reflect Falsified Medicines Directive verification status.

If a vendor cannot provide a clear authenticity statement for the stock they supply, that is a red flag. An SoA does not replace analytical release data, but it is the entry-level proof of provenance most QP reviews expect to see.

Certificate of Analysis (CoA) and Certificate of Conformance (CoC)

A CoA summarises the quality-control tests performed on a specific batch and shows results against specification. In many release workflows, a QP's confidence highest when a CoA is available.

A CoC often accompanies or is combined with a CoA. It typically states that the batch was manufactured, tested, packaged, and labelled in line with Good Manufacturing Practice (GMP). Formats differ by manufacturer.

CoAs are also frequently requested for import into certain countries, such as China. At the same time, a CoA is often over-requested when the product will be used inside its licensed territory and other authenticity and GDP evidence already exist. Ask whether the CoA is required for import, QP release into the trial, rather than treating it as automatic for every pack, as suppliers often increase the price of the product to include the CoA.

Batch Release Certificate (BRC)

A Batch Release Certificate confirms that a named batch is suitable for release under the applicable GMP and authorisation framework. In EU contexts, QP certification of a finished product batch is the formal quality release step before distribution for use.

For clinical supply, sponsors and QPs use BRC-style evidence to show that the batch was released under a controlled system, not merely sold as commercial stock. Exact titles vary. What matters is a clear statement linking batch identity to release authority.

Do not confuse a BRC with an SoA. Authenticity says the product is genuine and handled correctly. Batch release evidence speaks to the manufacturing and quality-release decision for that lot.

Need versus nice to have

Build the document list from the trial design, destination countries, and QP requirements:

1. Confirm where the product is licensed relative to where it will be used.

2. List import and customs document triggers for each destination.

3. Separate QP release needs from characterisation or bridging needs.

4. Ask your sourcing partner which documents are routinely available by market, which are slow, and which are rarely obtainable.

5. Challenge exhaustive wish lists that do not change patient safety or regulatory acceptability.

   
   

Other documents sometimes appear on wish lists, including GMP site certificates, BSE/TSE statements, equivalency statements, summary of product characteristics (SmPC), and stability data. Some are easy to obtain from public databases. Others are sensitive or uncommon. CSI can obtain these upon request, in most cases.

FAQ

What is the difference between a CoA and an SoA?

A CoA reports batch-specific analytical results against specification. An SoA (pedigree statement) confirms authenticity, key product identifiers, and compliant procurement and handling. They answer different questions and are often both useful.

Is a CoA always required for comparator use in the EU?

No. When an EU-licensed product is used at EU trial sites, authenticity and GDP evidence may be sufficient depending on QP and protocol needs. A CoA is more often critical for import outside the licensed territory or when the QP requires analytical evidence for release into the trial.

What does a Batch Release Certificate add?

A BRC-style document evidences that the batch underwent a formal quality release under GMP and the relevant authorization framework. It supports confidence that the lot was released for distribution, beyond commercial availability alone.

How can an oversized document list hurt a trial?

It can exclude lower-cost or faster markets, extend lead times, and force last-minute substitutions. The safer approach is a risk-based list agreed with the QP and grounded in destination and protocol requirements.