What is an Establishment Inspection Report (EIR)?

25.10.2021

Question of the Week

The EIR is the final inspection report of a FDA inspection.

[GMP Compliance Adviser, Chapter 21.D]

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24.11.2025

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How is a QRM process initiated?

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FDA: Updated Pre-RFD Guidance for Combination Products

The U.S. FDA has released an updated final guidance on preparing a Pre-Request for Designation (Pre-RFD), replacing the previous 2018 version. The revised document provides new recommendations for interacting with the Office of Combination Products (OCP) and clarifies expectations for Pre-RFD submissions.

EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

The EDQM has introduced a modular training programme covering chemically defined active substances and medicinal products. It will take place between 1 and 12 December 2025.