Certificates of Analysis help set the stage for success in manufacturing partnerships and reduce confusion.
What is a Certificate of Analysis?
A Certificate of Analysis (CoA) is a document typically prepared in regulated industries to inspire confidence in the buyer of a manufactured good. The information helps to convey how well the goods match the agreed-upon specification, and that FDA and other regulations are met.
What type of information is good to include in a Certificate of Analysis?
The purpose of a Certificate of Analysis is to communicate important product quality information to the entity that will further manufacture, store, or sell the good. So information included in the CoA should include the important quality information. The following list is a good place to start:
- A short report of objective-critical inspection results
- Work Order #/Batch #/Lot #
- Destination country
- Product code/SKU
- Lot expiration date, if applicable
Be sure to research into the regulated product characteristics in your industry, and be sure to include test results for those characteristics.
Certificates of Analysis help to increase communication between organizations about the manufacture of goods. Consider creating a repeatable template for Certificate of Analysis preparation, and be sure that you include regulated information. Good luck with the creation of your Certificate of Analysis.
Matthew Holden is a manufacturing quality journalist, and a member of the WinSPC marketing team.
About DataNet Quality Systems
DataNet Quality Systems empowers manufacturers to improve products, processes, and profitability through real-time statistical software solutions. The company’s vision is to deliver trusted and capable technology solutions that allow manufacturers to create the highest quality product for the lowest possible cost. DataNet’s flagship product, WinSPC, provides statistical decision-making at the point of production and delivers real-time, actionable information to where it is needed most. With over 2500 customers worldwide and distributors across the globe, DataNet is dedicated to delivering a high level of customer service and support, shop-floor expertise, and training in the areas of Continuous Improvement, Six Sigma, and Lean Manufacturing services.