What is a Certificate of Analysis (COA)?
A Certificate of Analysis (COA) is an official document issued by a manufacturer, supplier, or quality department that confirms a product meets its predefined specifications. It usually includes test results for certain parameters, methods used, and compliance with regulatory or customer requirements.
📋 What Information Does a COA Contain?
Typical elements of a COA include:
Product name and code
Batch/lot number
Manufacture and expiry date
Specifications and test methods
Actual test results (e.g., pH, purity, microbiological limits)
Approval or release status
Signature and date of responsible Quality representative
🧪 Uses of COA in Quality Department
Product Release Decision
Ensures that each batch meets quality standards before release.
Customer Assurance
Provides proof to customers that the product meets the required specs.
Regulatory Compliance
Essential for compliance with standards like FDA, GMP, ISO, etc.
Traceability
Allows for tracking of batch quality and helps in root cause analysis during complaints or recalls.
Internal Audits and Documentation
Serves as evidence of quality control during inspections and audits.
Supplier Quality Management
Used to evaluate raw materials or components supplied by third parties.
🏭 Common Industries That Use COAs
Pharmaceuticals
Food & Beverage
Cosmetics
Chemicals
Medical Devices