Certificate of Analysis (CoA): Definition & Key Requirements for 2025

Before generating a CoA, understand the regulations and compliance standards relevant to your product and industry (e.g., pharmaceuticals, food, or chemicals). This helps ensure your documentation meets both local and international quality norms.

Establish exact, quantifiable requirements for your product. These need to be predicated on your quality criteria, client expectations, and regulatory norms. The parameters for purity, composition, physical and chemical qualities, and microbiological limitations are commonly included in product specifications.

Create and execute thorough quality control testing protocols to see if your product satisfies the required standards. Make ensuring that these processes are carried out by qualified individuals utilising calibrated equipment and validated. A variety of evaluations, including microbiological analysis and physical and chemical composition assessments, could be included in the testing.

Compile all test data and do an analysis to make sure it complies with your product's requirements. This data has to be precise, dependable, and repeatable. Before moving forward, any deviations or deviations need to be looked at and fixed.

Ensure your Certificate of Analysis includes all required details:

• Product name and description
• Batch or lot number
• Manufacturing date
• Expiration date (if relevant)
• Product specs referenced
• A conformance declaration attesting to the product's compliance with requirements
• A summary of test results detailing the procedures followed and the results obtained
• The signature of authorised personnel
Make sure all data is accurate, current, and presented in a clear, professional format to meet compliance standards.

Design the CoA using a clean and branded layout. Prioritize clarity and logical structure so that customers and regulators can quickly find relevant information. The format should reflect your organization’s professionalism while maintaining readability.

The CoA must be authorised by a member of your regulatory compliance or quality assurance team before it can be issued. This person needs to confirm that all the details are accurate and that the product does, in fact, fit all the requirements.

Once approved, share the CoA with the product shipment or make it available on your website or client portal. Offering digital access increases transparency and customer convenience.

Keep a secure, well-organized repository of all CoAs for audit readiness and traceability. Update your templates and practices regularly to align with evolving regulatory guidelines and quality standards.

Review and update your CoA procedure on a regular basis to take into account user input, adjust for modifications to legal requirements, and implement new quality assurance best practices.