A Short Guide on Certificate of Analysis

Purpose and Benefits

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.

Although a COA is usually used for product inspections, having a COA is also important for suppliers’ product manufacturing and delivery. A COA can serve as an identification document for products, supporting the labels they come with as a COA has more details, such as the product’s components, their quality, and their purity. When transacting with customers, suppliers can then use their respective products’ COA to explain to the customer the type of product they are receiving. In this case, the COA can also help customers compare the products they received with the instructions they initially gave to check if they meet the prescribed standards.

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.

The authorities issuing the documents are also different. A COA is usually issued by a manufacturer’s quality assurance or quality control personnel who will then ensure the products’ authenticity and that they are fulfilling the prescribed standards set. In some cases, the issuing authority can also come from an inspection agency known by the manufacturer. On the other hand, a CoC can be given by a manufacturer’s authorized person or party, which includes third-party or external laboratories, certification bodies, and experts.

QA Specialist working on a COA

How to Create a Certificate of Analysis

There are many ways to create a COA, as each industry would have different testing methods and quality standards. However, the US Food & Drug Administration (FDA) requires all COAs to have the following elements:

• Manufacturer’s name and contact details
• Product name
• Batch number, as most products that are manufactured and call for a COA are usually created and tested in batches
• Active Pharmaceutical Ingredient (API), if applicable
• Grade
• Date of release
• Expiry date, if applicable, both on the label and COA itself
• Retest date, if applicable
• Each test performed, including their acceptance limits and numerical results if applicable

The FDA emphasizes that each COA should also be dated and signed by the authorized personnel from the manufacturer or supplier’s quality unit before release. In case of repacking and reprocessing, the COA should also show their details and include the original manufacturer’s.

For new certificates issued for or by repackers, reprocessors, agents, or brokers, their COAs should contain the details of the laboratory where the analysis was conducted for them, along with the original details and batch certificate that came from the manufacturer.