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:

09.01.2026

News

PIC/S: Jordan FDA Joins PIC/S

On 1 January 2026, the Jordan Food & Drug Administration (JFDA) became the 57^th PIC/S Participating Authority.

Swissmedic: Scientific GMDP Meetings

Swissmedic offers companies holding or seeking a Swissmedic manufacturing or distribution license the opportunity to discuss project-specific GMP and GDP topics in Scientific GMDP Meetings.

Purified Water – The new Chinese Pharmacopoeias and What Happens Next? NEU

A new Chinese Pharmacopoeia was published in 2025. This has some significant implications for the pharmaceutical water industry, which we will discuss in more detail in this article. Firstly, it is important to note that cold WFI systems are now permitted worldwide and can be used across the board.