Audit Checklist for Verification of Certificate of Analysis (COA) of API
| Section | Audit Point | Compliance (Y/N) | Remarks |
|---|---|---|---|
| General Information | Does the COA contain the name and address of the API manufacturer? | ||
| Is the COA dated and signed by the authorized personnel of the manufacturer? | |||
| Does the COA include a unique identification number or reference? | |||
| Is the Certificate of Analysis issued on the manufacturer’s letterhead? | |||
| Product Information | Is the API name clearly mentioned, including its generic or brand name (if applicable)? | ||
| Are the batch/lot number and manufacturing date clearly stated on the COA? | |||
| Is the expiry date or re-test date of the API mentioned? | |||
| Does the COA specify the packaging and storage conditions for the API? | |||
| Specifications and Results | Are the specifications listed in the COA in compliance with the pharmacopeial or in-house standards? | ||
| Are the test results provided for all critical quality attributes (e.g., assay, impurities, residual solvents)? | |||
| Are the test methods referenced in the COA (e.g., USP, BP, EP, or validated in-house methods)? | |||
| Are the results within the specified acceptance limits? | |||
| Is the microbial test result (if applicable) mentioned and within the limit? | |||
| Analytical Methods | Are the analytical methods validated and the validation data available for reference? | ||
| Does the COA mention the equipment or instruments used for critical tests (if applicable)? | |||
| Authenticity Verification | Is the COA traceable to the batch it represents? | ||
| Are the COA details verified against the approved vendor documentation? | |||
| Has the COA been cross-checked with the purchase order or delivery documents for consistency? | |||
| Regulatory Compliance | Is the API manufacturer listed as an approved vendor? | ||
| Does the COA comply with GMP regulatory requirements (e.g., 21 CFR Part 211, ICH Q7)? | |||
| Are any discrepancies in the COA immediately documented and resolved? |
This checklist ensures thorough verification of the Certificate of Analysis for APIs, focusing on accuracy, authenticity, regulatory compliance, and adherence to GMP guidelines.
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