FDA's CDER continues to work on its vision for 21st century pharmaceutical quality and supply chain security. A White Paper entitled "Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals" has now been produced. In principle, it is about possibilities for an objective assessment of the "Quality Management Maturity" (QMM) of pharmaceutical manufacturing facilities. A central aspect of this is a so-called "QMM Rating System", a programme for evaluating and rating the QMM of facilities using monitoring data and the participation of the companies.
For implementation, CDER has formed a "multidisciplinary, multi-Center working group", which is currently developing a corresponding programme. Initially, standardised assessment tools will be considered, but industry incentives, transparency and communication will also be included.
Central elements of the programme
Quality Culture as a basis with common business and quality goals: Employees at all levels of a company must contribute to the commitment to quality. A quality culture is necessary to achieve a high QMM level.
Objectivity of the QMM assessment tool: QMM assessments could be conducted either by the FDA or by an external contractor. The scope and impact of a QMM assessment differs from an assessment of pure cGMP compliance, as behaviours and quality metrics should also be assessed. The latter are to be routinely submitted to the FDA.
Incentives for industry: Regulatory and economic incentives for manufacturers in connection with QMM must be clear. These could be, for example, reduced inspection frequency or greater flexibility in post-approval changes. The goal is also more robust and reliable supply chains that serve everyone.
Transparency: The intention of the programme and the ultimate positive impact on drug shortages and the importance for patients needs to be understood.