GMP Requirements for Certificates of Analysis (CoA)

Recommendation

12-14 December 2023

Stability by Design - Live Online Training
- Stability Testing in Product Design and Method Development- Focus mainly on small-molecule APIs and drug products

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 don´t have this concretisation.