The importance of quality culture is finding more clear expression in the refinement of regulator and industry guidances that have been forthcoming recently on data integrity (DI) and what is required to assure it.
The introduction to FDA’s final DI guidance, released in December 2018, highlights the role of executive management in creating a “quality culture,” through which employees understand that data integrity is an organizational core value and are encouraged to identify and promptly report DI issues. This is important, the guidance asserts, because in the absence of management support of a quality culture, “quality systems can break down and lead to CGMP noncompliance.”
The culture and behaviors piece of the DI equation was also brought to the fore in MHRA’s draft DI guidance issued in 2015, and the 2018 revision retained that emphasis. In a February 2019 blogpost, MHRA inspector David Churchward highlighted the importance of quality culture.
The recognition of this importance is not a new development among UK regulators, Churchward explained, but has been in place since an aseptic failure led to a public health emergency in 1972. He pointed out that “senior management leadership and commitment of personnel at all levels (in other words, the organization’s ‘quality culture’) are the foundation of measures that ensure product quality and continuity of supply.”
Both regulator and industry experts are stressing that technical controls and instructions as prescribed in regulations and guidances alone are insufficient to assure quality, and that quality culture is needed to fill in the spaces that lie outside these technical controls, where actions and responses are shaped by mindsets and constructive impetus.
Understanding, establishing, and maintaining a quality culture – not only to remain in compliance but to excel organizationally – is being discussed at global pharma DI forums alongside the complex data system management concepts of Pharma 4.0 and the basic technical controls such as unique passwords.