What is a deviation?

15.01.2024

Question of the Week

There is no universal definition for the term "deviation". Each company must therefore determine for itself what is meant by deviations. Usually, this includes at least violations of limits in processes of manufacturing and testing as well as other systems and procedures.

[GMP Compliance Adviser, Chapter 1.E]

Would you like to discover more?

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

24.11.2025

Question of the Week

How is a QRM process initiated?

You can view the answer here:

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.