TASK Research Academy’s soon-to-launch course on Mastering Essential Records in Clinical Trials covers the Who, What, Where, Why, and How of all essential records involved in a trial, even the hidden ones. This includes the Certificate of Analysis (CoA).

Let’s be honest – it is not a record that monitors or CRAs pay much attention to. When encountered, it is often questioned as an essential record.

The Curious Case of the Certificate of Analysis

 

What is a Certificate of Analysis?

A Certificate of Analysis (CoA) is essentially a quality report card for a specific batch of investigational product (IMP), placebo, comparator, or even certain trial supplies. It’s issued by the manufacturer (or sometimes a qualified testing lab) and shows the results of tests that confirm the product meets predefined specifications. Things like identity, potency, purity, sterility, and even pH levels, depending on the product type.

At the end of the document, there’s usually a statement like “Complies with specifications” signed off by Quality Assurance or Quality Control. Without it, the product is not formally “released” for use in humans.

TRA Tip: Think of the CoA as the passport that allows a batch of drugs to enter the trial. No CoA, no entry.

Do you get a new CoA for every shipment?

Can it be assumed that every time a site receives a new delivery of IMP, it would come with a CoA?

No, that’s not quite how it works.

A CoA is tied to a batch or lot number, not the shipment itself. If a site receives a shipment of drug bottles or blister packs all from the same batch, only one CoA is needed for that batch, regardless of how many shipments are made.

But here’s the catch: if there are two different batches included in a single shipment, there will be two CoAs – one for each batch. The number of CoAs a site has on file depends on how many different batches of drug they’ve been supplied with during the trial.

When else do you see a CoA?

Here it gets interesting: CoAs are not only for the study drug.

You can also see them for:

  • Placebos – Even sugar pills need a CoA to prove they’re consistent, safe, and made according to specifications.
  • Comparators – if the trial uses an existing marketed medicine as a comparator, the sponsor may still issue a CoA to demonstrate that what’s being used is indeed what it claims to be.
  • Ancillary supplies – Ancillaries are things like diluents, reconstitution fluids, saline bags, or devices that are used to prepare, administer, or store the investigational product.

Some examples:

  • A sterile diluent used to mix with lyophilized drug powder.
  • Empty syringes or infusion sets provided by the sponsor for trial use.
  • Specialised packaging materials (temperature-controlled kits, nitrogen-flushed vials, stability-protective containers).

The CRA’s Quick Guide – When to Expect a CoA for Ancillaries

Ask yourself: Does this ancillary directly touch, hold, or deliver the IMP?

YES – Expect a CoA if:

  • It’s a syringe, vial, or infusion set supplied by the sponsor specifically for IMP administration.
  • It’s an infusion bag/diluent (e.g., NaCl, glucose) provided by the sponsor for preparing the IMP.
  • It’s specialised packaging that ensures IMP stability or integrity.

NO – Don’t expect a CoA if:

  • It’s a blood sampling ancillary (needles, vacutainers, cannulas, labels) for labs/safety tests.
  • It’s a general medical supply (gloves, plasters, PPE) unrelated to IMP preparation.

CRA tip:

  • Check the Pharmacy Manual or IP Handling Guide – if ancillaries are listed as sponsor-supplied, there should be a CoA.
  • In the Pharmacy Binder/TMF, CoAs for ancillaries will usually sit next to IMP CoAs.
  • If the protocol says, “site may use local supplies,” no CoA will be expected.

TRA Tip: Ancillaries only need a CoA if they’re part of IMP preparation, storage, or administration. Blood sampling or lab supplies don’t count.

Real-World Example: Saline, Infusion Bags, and Syringes

Imagine a shipment arrives at the site containing:

  • Saline solution (for diluting the IMP)
  • Infusion bags (to administer the diluted drug)
  • Syringes (to draw the IMP or diluent)

Even though they came together in one box, you should expect:

  • One CoA for the saline solution batch,
  • One CoA for the infusion bag batch, and
  • One CoA for the syringe batch.

Why?

Each product is a separate item, possibly manufactured and tested independently. Inspectors want clear documentation for every item that directly touches or delivers the IMP, so each product gets its own CoA.

TRA Tip: Shipment ≠ batch. Always check the batch numbers on the CoAs against what was supplied, even if items arrive together.

An “Aha Moment”: What about registered drugs?

If comparators can be marketed, registered medicines, does that mean there’s a CoA for them too? Or is the CoA only because the drug is “unregistered” and still investigational?

Here’s what we learned:

In clinical trials, yes – you can still expect a CoA for comparators and standard-of-care medicines, even if they’re already approved on the market. Why? Because once they’re pulled into the trial supply chain, regulators expect the same level of documentation and traceability as for the investigational product. A batch is a batch, and every batch needs a paper trail.

But in the real world, things work differently.

In a community or hospital pharmacy, pharmacists don’t receive or review CoAs for every box of medicine they dispense. Instead, they rely on the regulatory approval process and the fact that all commercial medicines are manufactured under strict GMP (Good Manufacturing Practice). Quality is guaranteed by the licensing system, not by filing a CoA with every shipment.

So, in practice:

  • Clinical trial world → CoAs are essential records, no matter whether the drug is investigational, placebo, comparator, or ancillary.
  • Pharmacy world → CoAs exist at the manufacturer’s level, but they don’t accompany every medicine delivered to a pharmacy. Pharmacists rely on the fact that the medicine is registered and regulated.

Lightbulb Moment

The CoA isn’t just about “unregistered” drugs but about proving trial supply quality in a way that goes beyond the normal commercial system.

In trials, everything needs a paper trail. Even registered comparators get CoAs. In normal pharmacy practice, CoAs stay behind the scenes at the manufacturer level.

What about customs?

If the IMP is imported into the country, do customs officials also ask to see the CoA?

The answer is yes, but with nuance.

  • When an investigational product lands at the border, customs work hand-in-hand with the national regulatory authority (like SAHPRA in South Africa, FDA in the US, EMA importers in Europe).
  • Part of the import clearance package includes the CoA, because it proves the batch has been tested and released for use. Without it, regulators may not authorise the product to enter the country at all.

Along with the CoA, the import file often includes:

  • Import permit or approval letter
  • GMP compliance certificate or manufacturer’s license
  • Certificate of Origin
  • Labels and specifications

For comparators, it depends:

  • If the comparator is purchased locally, no CoA is needed at customs — it enters the trial via the regular commercial system.
  • If the comparator is imported from another country, regulators may request a CoA as part of the clearance package, because once it’s part of the trial supply chain, documentation rules apply.

TRA Tip: Think of customs as the first “inspectors” your IMP meets. Without a CoA in the clearance package, the drug may not even make it past the airport.

Why does the Site Pharmacist or CRA care?

As a monitor or clinical trial site’s Pharmacist, you are not expected to verify whether sterility tests were properly done or whether impurity levels fall within limits — that’s the job of QA/QC at the manufacturer.
Your role, however, is to ensure traceability and documentation completeness.

That means checking the following:

  • Is there a CoA on file for every batch received?
  • Do the batch/lot numbers on the CoA match the labels on the supplies at the site?
  • Is the CoA signed/dated by an authorised person?
  • Do the CoAs also cover any placebos, comparators, or ancillaries used in the trial?
  • Are expiry dates consistent with what the site is using?

Here’s the thing: if regulators arrive and there’s no CoA for a batch that participants were dosed with, it raises a huge red flag. Without proof that the drug was tested and released, the whole chain of safety and compliance breaks down.

The Bigger Picture

The “less glamorous” trial records are truly essential as they all tie back to the same principles: participant safety, data integrity, and regulatory compliance.

The CoA might not be the first document a CRA thinks of, but it quietly sits in the background, underpinning the trust we place in the drugs used in our studies. Let this be a reminder that sometimes the records we overlook are the very ones that hold the trial together.

If you are serious about understanding Essential Records – the who, what, why, where and how, enrol for TASK Research Academy’s course launching in September 2025:

Mastering Essential Records in Clinical Trials.