What is an informal QRM method?

26.10.2020

Question of the Week

The term "formality" or "informality" should not be confused in this context with the basic requirement for documentation within the framework of good manufacturing practice. Rather, it means that methods and tools can also be applied which are not described in the literature or the internal procedures of a company or an organisation and which do not necessarily have to have a formal procedure or a defined scope.

[GMP Compliance Adviser, Chapter 19.D]

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.