by CMIDProduct documents help customers ensure that discussions, evaluations and information requests refer to the correct product identity. A COA is one part of that documentation pathway, but its contents and availability must always be interpreted for the applicable product and batch.
Five identities to distinguish
What is a COA?
A COA, or Certificate of Analysis, is an analytical document containing product or batch identity and test results for the parameters or criteria listed in that document. COA contents can vary by product, manufacturer, grade, batch and applicable requirements.
A COA supports evaluation and information traceability. Its existence does not, however, in itself prove that a material suits every formulation, process, application or customer purpose.
How to read the structure of a COA
Not a CMID batch document; contains no actual test results or specifications.
Product information and batch information are not the same
Helps identify a product
Covers general product identity or context based on the applicable source. It does not automatically describe analysis results for every batch.
Refers to a particular batch
Must be read from the matching batch document. A document for one batch, manufacturer, grade or product must not be assumed to apply to another identity.
From product identity to the correct document
Follow this sequence to keep product and batch information distinct.
How to find available documents
- Use the Product ID and product name to open the correct product page.
- Check the document or COA section on that page.
- Open only available documents that CMID has approved for publication.
- For a particular batch, match the document’s batch identity to the material being evaluated.
The absence of a document on a public page must not be interpreted as confirmation of specifications, batch status or product suitability.
Prepare this information when requesting document support
- Product ID
- Product name
- Batch identity, if known
- Type of document required
If a document is not publicly available
Contact CMID through the document-support pathway and provide the information available. The CMID team will help check suitable documentation pathways, without promising that every product has a public COA or that every document request can be fulfilled.
Documents support verification but do not replace suitability evaluation for a particular formula, process, application, safety, regulatory or customer requirement. Use the correct document for the correct identity.
References
FDA — ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, section 11.4, Certificates of Analysis.