What is Certificate of Analysis (CoA): An Overview

Certificate of Analysis. Hmm, sounds interesting.

What that could be?? Any guesses??

Well, a Certificate of Analysis (CoA) is an important document provided with a range of manufactured products like food, chemicals, research products, and pharmaceutical products. It is important for the customers to know that the product they are receiving adheres to their specific parameters and targets, and to ensure that it meets their needs. CoAs help your company prevent costly returns, replacements, or customer complaints.

A Certificate of Analysis is prepared for each batch of a substance or product and usually contains the following information:

The registration number of the sample;
Date of receipt;
The name and address of the laboratory testing the sample;
The name and address of the originator of the request for analysis;
The name, description and batch number of the sample where appropriate;
The name and address of the original manufacturer and, if applicable, those of the repacker and/or trader;
The reference to the specification used for testing the sample;
The results of all tests performed (mean and standard deviation, if applicable) with the prescribed limits;
A conclusion as to whether or not the sample was found to be within the limits of the specification;
Expiry date or retest date if applicable;
Date on which the test(s) was (were) completed; and
The signature of the head of the laboratory or other authorized person.

What makes up a CoA document?

The Food and Drug Administration (FDA) lists specific requirements for each CoA document your company produce. These include;

Supplier Information: This section contains data regarding the material supplier, including their name, address, and other contact information.
Materials Identification: The content in this section identifies the material being verified by this CoA. And it usually contains common terms such as lot numbers, product codes and descriptions.
Transportation Data: This area generally includes the customer name and address, original purchase order, or other details such as the item’s destination. This content is provided to meet shipping requirements and to help the receiver in confirming the material is authorized and its delivery is anticipated.
Evidence of Conformance: This section holds the most important information in the CoA. It states the specific characteristics, test results or other evidence in terms of industry standards, regulatory requirements or customer-specific requests. In some cases, the performance standards expected will also be noted for reference.
Signature Data: This last section of the CoA includes a signature indicating that the evidence presented was reviewed by a qualified and authorized product inspector.

What information is provided on a Certificate of Analysis?

The Certificate of Analysis includes the following:

Company Name/Identifier
Identification of Kit Product /Product Name
Kit Part Number/Catalog Number
Kit Lot Number
Test Conditions
Test Parameters
Specifications or Requirements
Results (qualitative and/or quantitative)
Approval Signature and Date
Relevant document traceability references (e.g. document number, revision, etc.)

Why is a Certificate of Analysis prepared and how is it utilized?

Certificates of Analysis can be used to satisfy qualification and/or acceptance activities (e.g. receiving inspection) by customers that are subject to regulatory or governing body expectations including, but not limited to the following:

Food and Drug Administration (FDA)
Clinical Laboratory Improvement Amendments (CLIA)
International Organization for Standardization (ISO)
Internal Quality System Procedures

Why does any company require a CoA?

Many manufacturers know there are advantages to creating CoAs but consider them too costly and time-consuming. However, without producing a trustworthy and accurate CoA, your company could face both business and legal consequences. These include, but are not limited to;

Decreased confidence in what gets shipped out
Increase in product recalls, wasting company time and money
The audit process becomes more complicated
Competitors can get the edge when they produce CoAs and you do not
Lost customers

The price of not having CoAs is quite high, much higher than the cost to produce CoAs in the first place. Without these documents, your company could very likely lose money, customers, and even credibility within your industry. While the process to begin creating and distributing CoAs may seem daunting, a document management system (DMS) can help.

What is the purpose of a CoA?

The main purpose of a CoA is to assure customers, manufacturers, and suppliers that the product they are dealing with meets their agreed-upon standards. The CoA is provided by the manufacturer and it is based on their capabilities and internal quality standards, the customers’ needs and targets, and, if applicable, the governing quality standard of the manufacturer’s city or country. Most countries require a CoA for importing and exporting food products, while for other products such as pharmaceuticals and chemical products, a stricter analysis process is needed. Some countries that implement this are Saudi Arabia and the US.

Difference between a CoA and a CoC

By definition, a CoA is very similar to a Certificate of Conformance (CoC). Like a CoA, a CoC is also a document that ensures a product’s specifications and quality are in line with the provided guidelines for it. Required in some countries and industries, a CoC can be produced if one intends to sell their products to other countries and markets as proof of quality assurance and compliance.

However, a major difference between a CoA and CoC is their content. While both documents are for quality assurance and standard compliance, a CoA is often more specific and stringent in its details. A CoA would sometimes include test conditions and specifications based on the provided guidelines, which also makes the products easier to trace.