Research conducted by trade associations, academics, and regulators has demonstrated that Quality Management Maturity is essential to achieving this vision.
To increase transparency and incentivize investment in pharmaceutical manufacturing, OPQ is developing a framework to objectively rate the Quality Management Maturity of pharmaceutical manufacturing sites.
QMM is the state attained by having consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. Gauging QMM requires, in part, determining how well and how thoroughly a manufacturer has implemented the concepts of ICH Q10.
A transparent rating system could inform purchasers about the level of QMM at sites from which they purchase drugs. In the absence of the transparency generated by ratings of QMM, there is risk that price competition and cost minimization will continue to be key market drivers, especially for generic drugs, without direct reward for manufacturers who actively invest to avoid future shortage.
Transparent QMM ratings could empower manufacturers to identify ways to improve the effectiveness of their PQSs, realize regulatory flexibilities described in ICH Q10, and help move the pharmaceutical industry toward the six sigma quality common in other industries (i.e., no more than 3.4 defects occur per million opportunities).
Mature quality management ensures not only that quality product is on the market now, but that quality issues will not keep a product from being available to patients and consumers in the future.
In addition to complying with CGMP requirements, an effective PQS is necessary for firms desiring to use the tools in ICH Q12.
The long-term effects of an FDA QMM program could be far-reaching:
Transparency in the market could provide top-rated manufacturers in the U.S., both large and small, with a competitive advantage, potentially enabling them to grow market share and increase their workforce.
Manufacturers with higher QMM focus on continual improvement and are therefore more likely to embrace advanced manufacturing technologies which can improve the #capability and robustness of the industry and lead to an expansion of domestic pharmaceutical manufacturing.
The potential benefits for stakeholders are clear:
- manufacturers with higher QMM get recognition in the market;
- purchasers and payors get more insight and confidence into the supply chain of the drugs or components they buy or reimburse;
- and patients, pharmacies, and healthcare professionals get medicine less at risk of shortage.
- everyone will have more confidence in the next dose of medicine.
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