What Is a Certificate of Analysis and Do You Need One?

If you operate under tight quality assurance and compliance regulations, a certificate of analysis (COA) will be an essential document. They are common in many industries, from pharmaceuticals to food production, ensuring products are safe, high-quality and meet regulatory specifications.

In this article, you’ll learn everything you need to know about certificates of analysis. That includes what they are, why you need one, how to get one and what to include.

What is a certificate of analysis?

A certificate of analysis (COA) is a document the manufacturer or supplier creates to confirm their products meet quality standards and regulatory requirements. It includes information about the product, the results of quality assurance tests and more.

In the chemical industry, for example, a COA may include information about the composition of a compound, its pH level and purity. In agriculture, it may contain nutritional data and allergen information.

What is a COA used for and who needs one?

Businesses and governments use a certificate of analysis to verify product quality, ingredients and safety. A COA services multiple functions, including:

• Quality assurance: It demonstrates a product has been tested and meets minimum quality criteria

• Regulatory compliance: It verifies a product complies with government regulations or international quality standards.

• Customer assurance: A COA lets manufacturers and importers prove to customers that the product matches any pre-agreed specifications. This reduces the chance of a complaint or return.

These functions make COAs essential in many industries where product quality impacts safety, performance and compliance. That includes the pharmaceutical industry (where COAs prove drugs meet safety standards), food and agriculture (where COAs prove food contains specified nutritional content) and cosmetics (where they confirm a beauty product’s ingredients are within regulatory limits for purity and safety).

What does a certificate of analysis include?

There’s a fair bit of information included on every certificate of analysis. That includes the following:

• Product information: The product name, lot or batch number. Include any other identifiers to ensure traceability.

• Supplier and buyer information: The name and contact details of the manufacturer and supplier, as well as the customer receiving the product.

• Test parameters: The attributes being tested, such as purity, pH, or viscosity, which demonstrate the product’s quality.
•  Specifications and standards: A list of the acceptable criteria for each attribute, ensuring the product meets industry or regulatory standards.

• Test results: The results from each test, showing whether the product meets or fails the specifications.

• Signatures: A signed statement from a quality assurance representative confirming the accuracy and authenticity of the COA.

The full contents of a certificate of analysis will depend on your industry and products. The above is just a guide

How to get a COA

You can acquire a certificate of analysis by arranging for your product to be tested according to industry standards. This can occur in-house or through a third-party service. In either case, the process looks like the following:

1. Conduct product testing: You’ll need to perform specific tests that change depending on your industry and product.
2. Analyse the results: A third-party or in-house testing lab will analyse and record the test results, verifying they align with established criteria.
3. Document and review: You document the test results in the COA, often including a formal review that’s sign-off by a qualified quality control specialist.
4. Send the COA to customers: The completed COA accompanies the product during shipping or is sent directly to customers.
   

Don’t forget to store a copy of each COA yourself for regulatory compliance and future audits.

What happens if you don’t have a COA?

A certificate of analysis is a must-have document when shipping and selling highly regulated products. Failure to create or include one comes with some serious consequences.

Chief among them are the consequences of non-compliance. In some cases, products won’t pass through customs without a COA. Not including one can also lead to regulatory fines and legal actions.

The reputational damage of not having a COA is also severe. Without a COA there’s a much higher risk of delivering subpar products, which can lead to complaints, returns and a loss of trust.

What’s the difference between a certificate of analysis and a certificate of conformance?

A certificate of analysis (COA) and a certificate of conformance (CoC) sound the same, but they serve two very different purposes.

While a COA, as we have already explained, provides specific test results and data verifying a product’s compliance with regulatory standards, a CoC is a more general statement that a product meets a customer's overall specifications.

A COC is far less strict than a COA and does not include detailed test results or in-depth quality assurance.

Ship goods safely with Pro Carrier

Whether you are shipping goods that require a COA or a CoC, Pro Carrier can ensure you meet all regulatory and legal requirements. We understand the importance of documentation when shipping goods from the Far East to the UK and beyond. We’ll make sure you have all of the documents you need to clear customs well in advance to avoid delays, searches or fines,

For more information on how we can help, speak to an expert today.