Certificate of analysis

Certificate of Analysis (CoA) is a document issued by Quality Assurance that confirms that a regulated product meets its product specification. They commonly contain the actual results obtained from testing performed as part of quality control of an individual batch of a product.

Definition

A Certificate of Analysis is a document issued by a Quality Assurance (including GMP, GLP, ISO 17025) body that confirms that a regulated product meets its product specification. It contains the actual results obtained from testing performed as part of quality control of an individual batch of a product.

Content

A CoA includes the product name, batch number, date of manufacture, expiry date, and the individual results from all tests performed. The tests performed and their specific results are highly dependent on the product type and its specification. For example, a pharmaceutical company may test for the presence and amount of active pharmaceutical ingredients, the absence of certain contaminants, the amount of moisture in the product, and the product's ability to dissolve (a requirement for products such as tablets and capsules).

Importance

The CoA is an important document in both the production and purchase of products requiring high levels of quality control and assurance. For the producer, it provides a degree of confidence in their own production and quality control processes. For the purchaser, it provides confidence in the quality of the product they are purchasing.

See also

• Quality Assurance
• Good Manufacturing Practice
• Good Laboratory Practice
• ISO 17025

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