Skip to main content Skip to search Skip to main navigation

What is an informal QRM method?

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:

What are the quality requirements for pharmaceutical gases?

What are the quality requirements for pharmaceutical gases?

You can view the answer here:
Read more
EMA: Update on the Guideline “Stability Testing for Variations”

EMA: Update on the Guideline “Stability Testing for Variations”

The EMA has updated the guideline on stability testing for variations (Revision 3, applicable from 15 January 2026).
Read more
EU: Proposal for Simplification of Medical Device Rules

EU: Proposal for Simplification of Medical Device Rules

The European Commission has proposed targeted reforms to simplify the Medical Device Regulation (Regulation (EU) 2017/745, MDR) and the In Vitro Diagnostic Regulation (Regulation (EU) 2017/746, IVDR) and to address structural implementation challenges.
Read more
Previous
Next