FDA's Pharmaceutical Quality Initiatives: Implementation of a Modern Risk-based Approach - Pharmaceutical Technology

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FDA's Pharmaceutical Quality Initiatives: Implementation of a Modern Risk-based Approach
The US Food and Drug Administration announced its Pharmaceutical GMPs for the 21st Century initiative six years ago. This article reports on the outcome of a recent workshop on this topic and the action plan set forth.


Pharmaceutical Technology


Implementation of quality systems: opportunities and challenges breakout report

The concept of a quality system has been described in FDA's Guidance for Industry: Industry Quality Systems Approach to Pharmaceutical CGMP Regulations and will be further articulated in ICH Q10. The combination of QbD, use of risk- management principles, and an appropriate quality system should lead to "a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight" (1). This breakout session explored the understanding and implementation of the quality system concept along with relevant challenges and successes. Aspects of the quality system that were discussed included change management, and integration of risk management and knowledge management.

There is increased understanding of the role the quality system plays in achieving a science- and risk-based approach to pharmaceutical manufacturing over the product life cycle. As a result, the design and effectiveness of the quality system is an emerging area of discussion and effort. There was shared understanding among participants on the significance of management's role in a quality system's effectiveness. In addition, they identified the crucial role of the change management system and the use of the principles and tools of knowledge and risk management. As the pharmaceutical business moves to a global platform, discussants reinforced the need for and the value of global harmonization of a regulatory guidance for quality systems.

ICH and international activities breakout report

International cooperation has been one of the guiding principles of FDA's CGMPs for the 21st Century quality initiative. The agency's global strategy to improve the quality of pharmaceutical products includes enhancement of relevant international harmonization activities and increased sharing of regulatory information with counterpart authorities in other countries. Because it is crucial that pharmaceutical quality standards and requirements be harmonized to the fullest extent possible, collaboration with industry and other regulatory authorities through the International Conference on Harmonization has been an important aspect of FDA's overall international strategy. ICH Guidelines Q8, Q9, and Q10 are the cornerstones of the new ICH quality vision of creating a regulatory framework that enhances public health promotion and protection.

At a Fall 2006 ICH meeting in Chicago, representatives discussed the future vision for ICH quality topics. The objective of the meeting was to identify those areas in pharmaceutical quality which need to be addressed at the ICH level to further advance the goal of achieving the same global submission. ICH's industry representatives and obervers from Europe, Japan, and the US came with an aspirational view to achieve a transparent, science- and risk-assessment based approach to product development, dossier submission, review, consistent implementation of Q8, Q9, and Q10 across the ICH regions, as well as some future opportunities for new ICH quality topics that could be addressed to help achieve the objective cited above.

Question-based review (QbR) initiative: Office of Generic Drugs breakout report

FDA's Office of Generic Drugs (OGD) publicized its question-based review (QbR) approach in 2005. Over the course of 2006, some sponsors began to address QbR questions in their abbreviated new drug applications (ANDAs). OGD began to fully implement the QbR approach in 2007. This Pharmaceutical Quality Initiatives Workshop session discussed the effect of QbR on the generic drug-development process and explored the use of directed questions to guide sponsors in preparing quality overall summaries that lead to efficient application review.

Based on early experiences and initial feedback, participants found that QbR has encouraged generic sponsors to use QbD elements and principles, changed the paradigm of the generic pharmaceutical development process, and changed the quality assessment within OGD with positive comments from the reviewers.

Generic industry is interested in knowing how much more information on development activities is needed for filing ANDAs. They would like OGD to provide more clarity on expectations for the quality overall summary and pharmaceutical development report. In addition to the current proposal for supplement reduction, industry representatives would like additional metrics that go beyond the preliminary risk-assessment strategy proposed by OGD. ANDA sponsors also would like OGD to use postapproval data to evaluate and grant regulatory relief. For some firms, additional development work (e.g., process) will be needed to fully address QbR before submission.


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