A Certificate of Analysis, CoA, is a document, usually issued by an organization’s quality department, that asserts that a product or material has met all the required predetermined specifications. A CoA is utilized by multiple industries but is particularly important in the pharmaceutical industry. Manufacturers, in particular, need CoAs in order to verify that raw material is actually what they ordered. Without a CoA extensive testing will need to be on the material in order to verify what the material actually is.

Within the pharmaceutical industry, the CoA is particularly important for Active Pharmaceutical Ingredients (APIs). The CoA helps to identify APIs in a product or ensure that the raw material provided what was requested. A CoA will need various things such as the lot/batch number, the expiration date, and the date of release.[1] A CoA will also list all testing done on a material or product, which in turn will allow the buyer to analyze the CoA for accuracy and compare the results of the original manufacturer to any testing done after the receipt of the material. The testing should have the results as well as the acceptance criteria and the test method used for conducting the test.

A CoA should also note the original manufacturer of the product or raw material. This allows for traceability throughout the supply chain of the final product. Should something end up being wrong with the final product that traceability can be used in finding the source of the issue, thus making it easier to correct the issue. Without that knowledge, the manufacturer may learn that something is wrong with the final product but not understand the root cause of why it went wrong in the first place.

Receiving a CoA is part of the overall supplier management system of an organization. Suppliers of the organization should all understand that they will need to send the CoA with any materials or products they deliver to the organization. EMMA International can help provide assistance with acquiring and understanding CoAs. In addition, EMMA International can help build and establish a supplier management system that makes it easy for suppliers to understand the needs of the organization.  EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.

[1] FDA (August 2018) Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Retrieved 03/13/2022 from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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