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GMP Requirements for Certificates of Analysis

At times of outsourcing and globalisation, the significance of Certificates of Analysis
(CoA) is growing. Ultimately, the user of such certificates has to rely on their accuracy
and completeness.

There are CoAs for excipients, APIs, packaging materials and finished products. A
closer look at the guidelines shows that there are a few regulatory requirements which
are often unknown. Requirements can be found in the following sets of rules:

EU GMP Guide Part I (Chapter 4 and Chapter 6)

EU GMP Guide Part II - Section 11.4
EMA Guideline on batch certification (Internationally harmonised Requirements
for Batch Certification)
WHO Annex 10 - Model Certificate of Analysis
USP General Chapter <1080> Bulk Pharmaceutical Excipients - CoA
IPEC CoA Guide for Pharmaceutical Excipients

According to the EU GMP Guide Part I, certificates of analysis provide an overview of

test results obtained from a product or a material. This also includes the assessment
of compliance with the specification determined.

Section 11.4 of the EU GMP Guide Part II on certificates of analysis requires an

authentic certificate of analysis for each batch of an intermediate or API. Among other
things, this certificate should contain the following information:

Name of the intermediate or API

Batch number
Release date
Expiry date
List of the tests performed including acceptance limits
Numerical results
Dated signature by authorised personnel
Name of the company
or Name of the laboratory

You can find specific requirements regarding CoAs in these GMP guidelines. This is a
difference to other quality guidelines like e.g. ISO 9001, where you dont have this