Define: Certificate Of Analysis

A Certificate of Analysis is a document issued by a laboratory or testing facility that provides detailed information about the composition, quality, and purity of a product. It is often used in the pharmaceutical, food, and manufacturing industries to ensure that products meet regulatory and quality standards. The certificate typically includes information about the testing methods used, the results of the analysis, and any relevant specifications or standards that the product meets. It serves as a legal record of the product’s quality and can be used as evidence in legal proceedings or regulatory inspections.

A Certificate of Analysis (COA) is a document generated by manufacturers to confirm that the product they have manufactured meets the specific requirements of their customers. This document is crucial for customers to ensure that the received product aligns with their defined parameters and targets, thus meeting their expectations and needs. COAs play a vital role in helping companies prevent costly returns, replacements, or customer complaints. In this article, we will explore the significance of COAs and discuss effective methods for managing them within your company.

What makes up a COA document?

COA documents encompass the following key sections:

• Supplier Information: This section provides details about the material supplier, including their name, address, and contact information.
• Materials Identification: This section identifies the material being verified by the COA, typically including information such as lot numbers, product codes, and descriptions.
• Transportation Data: This area includes customer name and address, original purchase order details, or other shipping-related information to confirm material authorization and delivery expectations.
• Evidence of Conformance: This critical section presents specific characteristics, test results, or evidence related to industry standards, regulatory requirements, or customer-specific requests. It may also outline performance standards for reference.
• Signature Data: The final section of the COA contains a signature from a qualified and authorised product inspector, confirming that the presented evidence was reviewed.

Each of these sections and pieces of data is essential for ensuring that your COA is considered a valid inspection of your product. Failure to include this required information could lead to legal or business repercussions.

What are COAs used for?

As mentioned earlier, Certificate of Analysis (COA) documents serve to demonstrate that the products manufactured meet the expectations of your customers. With manufacturers producing numerous items, it can be challenging for companies to effectively track materials throughout the entire production process. Therefore, companies increasingly rely on suppliers to deliver high-quality materials for their finished products.

A COA serves a dual purpose beyond product inspection. Given the rapid movement of materials across different locations, it is essential to accurately identify and clarify shipped materials. In addition to material and container labels, the COA serves as a comprehensive identification document for each product’s status. These documents provide more detailed information than typical labels.

The COA plays a crucial role in conveying information from a material supplier to a material user regarding the identity, quality, and purity of specific materials. It is imperative for material suppliers to provide trustworthy COAs to ensure that customers fully understand the nature of the products they receive. Upon receipt, the customer can compare the information on the vendor’s COA against their specifications to confirm whether the material meets the required criteria.

Why does your company need to produce COAs?

Many manufacturers know there are advantages to creating COAs but consider them too costly and time-consuming. However, without 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
• 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 of producing 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 of creating and distributing COAs may seem daunting, a document management system (DMS) can help.

This site contains general legal information but does not constitute professional legal advice for your particular situation. Persuing this glossary does not create an attorney-client or legal adviser relationship. If you have specific questions, please consult a qualified attorney licensed in your jurisdiction.

This glossary post was last updated: 28th April 2024.