Formerly ICH Q10, since 2013 defined in chapter 1 EU GMP guide: the Pharmaceutical Quality System.
But many companies still struggle with its implementation. QM systems and its documents are often rigid, expanded and not well-structured, Similar topics are handled in different parts and in several SOPs - sometimes in a contradictory way. Relevant aspects are not covered. Document templates are missing or so rigid you can hardly work with. Trying to make it right for the regulatory authority, lots of paper is created and things are described which no one needs.
How much QM is necessary? Does QM need to be a rigid system or can it also be flexible and nonetheless create GMP-compliant and clear framework?

We invite you for a discussion and exchange of experiences because there are really good strategies!