What Is a Certificate of Analysis?

It’s not one of the most common export documents, but your foreign buyer may request a certificate of analysis (COA) to ensure the quality and safety of the product you’re exporting, especially for pharmaceuticals, food, chemicals, dietary supplements or other regulated goods. Likewise, if you’re importing goods into the U.S., a COA may be required by the Food and Drug Administration (FDA) or another regulatory agency to prove compliance with safety and quality standards. A COA is a document that certifies products meet agreed‑upon specifications—including composition, identity, purity and quality—based on laboratory testing and analysis.

Often when a COA is required, it must accompany the shipment of the goods, and in some cases, a customer is not allowed to accept a delivery without it. In this article, we explain:

• what a COA is
• who needs it
• how to create one
• required contents of the document
• regulatory context and risks of skipping it

Who Needs a Certificate of Analysis (COA)?

Regulations vary internationally, but generally, a broad spectrum of goods, from medicines and food to toys and heavy-duty machinery, may require a COA. The document will show that consumables are safe to consume (along with what the product is made of), and in the case of toys or machines, it will show that regulatory and safety requirements are met.

Manufacturers and distributors rely on them to verify the quality of their goods; regulatory agencies, such as the FDA or the European Medicines Agency (EMA), require them to show quality and safety standards are adhered to; and consumers benefit from them because they instill confidence regarding a product’s reliability.

How Do You Create a Certificate of Analysis?

According to the International Trade Administration, a COA “can be issued by a certification authority or by the exporter if the buyer agrees. Certificates of analysis may be obtained from an accredited laboratory.” Manufacturers submit final products or components to certified laboratories for testing. These are some of the steps that should be followed to improve accuracy:

• Sampling: Samples of the product are collected at various stages of production. These samples should be representative of the entire batch to ensure the COA accurately reflects the overall quality.
• Testing and Analysis: Rigorous testing and analysis are conducted on the collected samples. This may include physical, chemical and microbiological testing, depending on the nature of the product.
• Documentation: All test results and relevant information are documented in the COA. This documentation is crucial for providing a clear overview of the product's quality.
• Verification: The COA should be verified by qualified personnel, such as quality control experts or laboratory technicians, to confirm the accuracy of the information provided.

What Information Belongs on a Certificate of Analysis?

This is some of the information that is typically included on a COA (the FDA lists specific requirements here):

• Product Identification: Product name, code, batch/lot number, manufacturing date and expiration if applicable.
• Supplier: Contact information for the materials supplier. 
• Materials: Lists the materials that are being verified, along with lot numbers, product codes and descriptions. 
• Transportation: This section is provided to meet shipping requirements and confirm that the product is expected at the named destination. It will include the receiver’s name and destination, possibly the bill of lading number and any other transportation-related requirements.     
• Conformance: Specifies the standards used for comparison during testing, ensuring that the product meets predetermined criteria.
• Signature: Includes the signature of an authorized individual, affirming the accuracy and validity of the COA.

How Does FDA Regulation Interact with a COA?

It’s important to understand that a COA itself is not a standalone FDA‑issued export certificate, but rather a quality document prepared by the manufacturer or lab. However:

• FDA Export Certificates: For food and beverages regulated by the FDA, exporters can request export certifications showing compliance with U.S. regulations for markets abroad.
• Pharmaceutical Products: The FDA issues Electronic Certificates of Pharmaceutical Product (eCPP) for approved or qualifying drugs through a dedicated export certification system.
• U.S. Imports: A COA may be used by importers to demonstrate compliance with U.S. regulatory requirements, such as identity, strength, quality and purity, during inspection.
  
  

In regulated industries (e.g., pharmaceuticals or dietary supplements), current Good Manufacturing Practice (cGMP) guidelines expect manufacturers to include COAs as part of their quality systems and product release protocols.

What Happens If You Don't Use a Certificate of Analysis?

Skipping a COA may seem like a cost‑cutting choice, but it comes with real risks:

• Customs or regulatory delays when products can’t be cleared without quality evidence.
• Rejected shipments or returned goods by foreign buyers.
• Fines, penalties or hold orders if products fall under regulated categories without proper documentation.
• Loss of trust from customers and partners when quality can’t be verified.
• Competitive disadvantage compared to suppliers who proactively provide COAs.

Other Export Documents You Might Need

A COA is just one part of your export documentation toolkit. To ensure timely delivery and compliance with international regulations, you’ll likely need additional forms such as:

• Commercial Invoice
• Packing List
• Certificate of Origin
• Export Licenses (if applicable)

Download our free guide, The Beginner's Guide to Export Forms, for a complete breakdown of required export documentation.

And if you’re tired of manual paperwork, learn how Shipping Solutions Export Documentation and Compliance Software automates accurate, compliant export form creation. Let us show you how it works!

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This article was first published in December 2023 and has been updated to include current information, links and formatting.