What needs to be considered when validating a sterility test method?

23.09.2024

Question of the Week

It is important to carry out a drug substance/drug product-specific validation before using the sterile test. The sterile test methods as such can be regarded as validated.

[GMP Compliance Adviser, Chapter 12.F]

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.