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Certificate of Analysis Guide for Pharmaceutical Excipients

The Certificate of Analysis (COA) is a legal document that certifies the quality of the excipient and demonstrates that the batch conforms to the defined specifications, has been manufactured under excipient GMP and is suitable for use in medicinal products. 

A COA for excipients should be prepared and issued by the company responsible for the material. But it should not be used in lieu of appropriate qualification of the supplier.

It is expected that a complete and accurate COA is provided to the excipient user for each batch. An additional COA is issued when additional testing is performed by a distributor.

Although identification (ID) tests are typically part of a compendial monograph, identification testing by the excipient manufacturer is not a regulatory requirement in some countries.

In such instances, identity testing may be waived for dedicated processes or if the excipient manufacturer has process controls in place that together with testing assure the identity of the excipient.

Note: In most countries, identification testing is a regulatory requirement for the medicinal product manufacturer to perform on each receipt of an excipient. There are multiple ways of including ID testing on the COA.

If tested routinely, ID should be listed on the COA (in the test table) with reference to the specific test performed. If the ID test is not performed on the batch, this should be clearly indicated on the COA.

This document is meant to serve as a guide for the preparation and appropriate use of a Certificate of Analysis (COA) for pharmaceutical excipients (excipients). The goal is to standardize the content and suggest a format for COAs for excipients, and to clearly define the roles and responsibilities for the excipient manufacturer and distributor.

Contents of COA

  • Titled “Certificate of Analysis”
  • Identity name and address of original manufacturing site
  • Responsible organization that issues the COA, address, and contact information (if different from original manufacturer),
  • Name (compendial or chemical) and compendial designation, as applicable
  • Grade
  • Trade name
  • Batch number
  • Date of manufacture
  • Unique identifier to the excipient specification (e.g., USP, NF, Ph. Eur., JP, ChP)
  • Expiration or retest date (as applicable) or stability statement
  • Where applicable, storage conditions may be mentioned, e.g., for moisture or temperature sensitive materials
  • Specification (Attribute name, Reference to the test method, Acceptance criteria or reference to alternative document (e.g., customer-specific criteria included in the Quality Agreement)
  • Analysis [Test results based on finished excipient sample, or Alternative test results, as appropriate, Date retested and retest interval (if appropriate)]
  • Additional compliance statements and applicable references to standards
  • Identity of authorized individual for approval or electronic signature statement

This guide is applicable to excipients used in the manufacture of medicinal products. Information in the guide may also apply to excipients used in veterinary medicines.

When considering the use of this guide, manufacturers and distributors should consider how it may apply to that specific organization’s product. The diversity of excipients means that some principles of the guide may not be applicable to certain products and processes.

This guide includes notes that offer common examples for interpretation and implementation without adding further requirements.

Read also: Pharmaceutical Excipients in QbD

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