A Certificate of Analysis (COA) is issued by a laboratory showing the test results for raw materials and finished products. It will usually confirm ingredient potency, identity and the absence of harmful levels of heavy metals, microbial content, pesticides, and certain pathogens. A COA can be obtained for both raw materials and finished goods.
A COA will always refer to one batch – so it will show the lot number printed on the finished good container, or the lot number from the raw material supplier. It is vital to verify every lot against the COA as there can be differences depending on the raw material and production conditions.
What will a COA tell me?
- Identity – that the ingredient is what the supplier claims it is. As part of 21 CFR Part 111 supplement manufacturers are required to perform identity testing on every incoming raw material.
- Purity (Free from Contamination) – ensures that the raw material / finished good does not contain contaminants in harmful levels. The most common contaminants are the big four heavy metals, microbial contamination, yeast and mold count and the absence of Salmonella and E. Coli.
- Strength (Potency) – confirms that the concentration of the ingredient meets the claimed specification. E.g. if the label claims there is 1000mg of Vitamin C, the COA will show whether or not this claim is being met.
- Composition – the general makeup of the raw material or finished product E.g. if a supplier claims that the Manganese Chloride is 20% manganese and 80% chloride, the COA will ensure that the composition is what is stated.
Why do I need it?
The COA is vital when it comes to identifying any potential issues with your product before it is released and put on the shelves. It will highlight any issues with the product not being within specification meaning that you can troubleshoot issues at the root cause.
It is an important document to have in the unlikely event that there are issues with a specific lot, particularly regarding customer complaints and adverse events. If there is a problem you can go back to the lot-specific COA to show that at the point of manufacture there were no issues identified.
What will I see when I look at a COA?
A COA will show a number of items that have been tested;
- Appearance and odor
- The main ingredient(s)
- Four heavy metals – lead, mercury, cadmium and arsenic
- Plate count and yeast & mold
- Pathogens including E. Coli and Salmonella
- And more!
The COA will indicate the specification range indicated for the product, what the result of the testing was and the method by which the testing was undertaken.
It should always include the lot number of either the raw material or the finished good.
What is not included in a COA?
It does not state everything inclusive of the entire formulation – it will not test for the excipients or fillers that are listed on the supplement facts panel, this allows for the protection of proprietary blends to ensure the entire formulation is kept safe from competitors.
It is also not exhaustive of everything that can be tested – if you need something specific you will need to speak to your chosen laboratory about whether they are able to conduct that testing.