Key indicators of a healthy quality culture include a company’s understanding of ● the price of noncomformance ● the difference between change control and change management, and ● the value of openness with regulators, UK Medicines and Health products Regulatory Agency (MHRA) Expert GMP Inspector Ian Thrussell stressed at a quality systems/ICH Q10 conference in Arlington, Virginia in early October.
Heavily involved with shaping GMP regulatory policy in the MHRA and EMA contexts as well as in ICH as part of the Q10 Expert Working Group (EWG), Thrussell is well qualified to gauge where companies are on the quality systems curve. At the conference, he provided a revealing analysis of what makes a quality system work and what goes wrong when it doesn’t.
The Q10 conference brought together senior industry quality management and key US and European regulators to do three days of benchmarking and brainstorming on the implementation of quality systems – how the concepts have evolved and impacted industry and regulatory processes, what the emerging goals are, and where the obstacles to further progress lie.
The conference was cosponsored by the associations PDA and ISPE in conjunction with FDA and EMA. A companion European meeting with a similar lineup of topics and speakers was held in Brussels, Belgium in mid-November.
In his presentation, Thrussell delved into:
● the difficulty inspectors have in assessing the human interrelationships in firms
● how to decide who senior management is, and why it is important to know
● why issues with investigations perennially top the list of inspection observations
● the important differences between change control and change management
● the problem of imbedding quality systems in people rather than in organizations
● the significance of management reviews of process and product performance
● why the approach of providing minimal information to agency inspectors needs to change, and
● how inspectors can tell if a company’s quality culture is on the right track.