Originally published in GMP Journal on 5 March 2026, this article explores why robust GMP systems alone do not guarantee reliable performance. Culture influences whether people speak up, challenge assumptions, learn from deviations and use professional judgement when reality does not fit neatly inside a procedure.
The article connects quality culture with leadership behaviour, psychological safety, governance, CAPA effectiveness, SOP design and meaningful cultural indicators — and develops the idea that (Organisation + Systems) × Culture = Performance.
Read the original German article in GMP Journal.
