Certificate of Analysis
A document reporting the results of laboratory testing on a product batch, confirming it meets specified quality standards.
What It Is
A Certificate of Analysis (CoA) is issued by a laboratory or the manufacturer's quality control department. It reports the results of physical, chemical, or microbiological tests performed on a specific batch or lot of product. The CoA confirms that the product meets the buyer's specifications, regulatory requirements, or industry standards.
CoAs are common in industries where product quality is regulated or contractually guaranteed, including pharmaceuticals, food and beverage, chemicals, cosmetics, and electronics.
When It's Required
- Pharmaceutical exports — Required by virtually all importing countries for drugs, APIs, and excipients
- Food and beverage — Required for many regulated food products, especially infant formula, dairy, and dietary supplements
- Chemicals — Required when the buyer or importing country mandates purity or composition verification
- Contractual — Often required by purchase contracts or letters of credit
- Regulatory — Some countries require CoAs for customs clearance of specific product categories
Required Fields
| Field | Purpose |
|---|---|
| Manufacturer / supplier | Company issuing the certificate |
| Product name | Commercial and/or scientific name |
| Batch / lot number | Unique identifier for the tested batch |
| Manufacturing date | Date the batch was produced |
| Expiry date | Product shelf life or retest date |
| Test parameters | List of tests performed (e.g., purity, pH, moisture, microbial count) |
| Specifications | Acceptable range or limit for each parameter |
| Results | Actual test results for each parameter |
| Pass / fail determination | Whether each parameter meets the specification |
| Testing method | Analytical method used (e.g., HPLC, GC, USP) |
| Testing laboratory | Name and accreditation of the lab |
| Authorized signatory | Name and title of the person certifying the results |
Klervex Validation
Klervex validates that:
- Product identification and batch/lot number are present
- Test parameters and results are provided
- Each result has a corresponding specification for comparison
- Manufacturing and expiry dates are present and logically consistent
- Testing laboratory and authorized signatory details are complete