A certificate of analysis (CoA) is a document that manufacturers create that verifies the products they manufacture conform to the customer requirements. This document helps ensure the customers know what product they are receiving and that it adheres to the specific parameters and targets. 

This document reports the quality assessment of the production lot and helps assure the customer the product they receive meets the desired quality standards. This is particularly useful in research, pharmaceutical, and biologics markets. Most of the products are produced in batches, as each batch or lot released needs to be under quality assessments to ensure the product’s purity, safety, and potency (if applicable). The parameters of each product and assessment vary depending on the manufacturer’s preference. A certificate of analysis must include: 

  • Supplier information: including the name, address, and contact information
  • Material Identification: this section identifies the verified material and usually contains lot numbers, product codes, and descriptions. 
  • Conformity evidence: specific information on the material is included in this section, such as characteristics, test results, and any customer requests. 
  • Signature: a signature indicating the evidence was reviewed and qualified by the product inspector is necessary. 

While CoAs are important, it is crucial that manufacturers do not rely solely on them. Given the complexity of outsourcing and supplier management, it’s essential to trust the information given on the CoA but to verify it. In general, this is done through verification of the supplier. 

A systematic approach to verifying supplier data is essential in any regulated industry. Pharmaceutical companies need to test the identity of incoming APIs and ingredients to confirm the supplier CoAs. The CoA is only one factor of many that impact verification of the quality of the product. A comprehensive quality system is important to any manufacturer since they may fail to consider the importance of document control, data review, and auditing. Not only can these processes help reduce the risk of data integrity failures as a cause of inadequate training, but they can also help communicate with the supplier.  Raw materials are vital to producing a high-quality end product. As such, it’s important to verify the CoA provided with any raw material and complete supplier verification. EMMA International has extensive knowledge and experience helping manufacturers verify their suppliers to produce quality and safe end products. For more information, contact EMMA International by phone at 248-987-4497 or by email at info@emmainternational.com

Emma International

Emma International

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Process Validation

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Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
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In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

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