Benefits of QbD
Strongly focused on collaboration between research and manufacturing, QbD advances process understanding for increased effectiveness
and efficiency. The "real time, real data" sharing of industry knowledge optimizes front-end design to more fully support
the product life cycle. The science- and risk-based approach boosts regulator confidence by minimizing regulator risk. Because
QbD brings medicines to patients in a better-understood and fundamentally more reliable way, consumers benefit as well.
QbD reduces postapproval regulatory submissions, minimizes risk around manufacturing failures and product recalls, trims non-value-added
regulatory and compliance activities, and facilitates novel approaches to process validation. At the same time, QbD improves
regulatory flexibility, process understanding, and application of technology. QbD hones regulatory-review criteria, capitalizes
on experience to leverages industrywide expertise, and fosters global harmonization that will benefit the global pharmaceutical
industry, its consumers, and other stakeholders.
QbD concepts coincide with a burgeoning global industry movement toward building quality into pharmaceuticals from development
through manufacturing by bridging gaps between pharmaceutical development and manufacturing and using sound science to demonstrate
and assure the product's safety, quality, and efficacy throughout its entire life cycle. Launched in 2007, the Product Quality
Lifecycle Implementation (PQLI) initiative is a global, industry-led effort led by International Society for Pharmaceutical
Engineering to facilitate the implementation of ICH standards.
Pfizer is actively engaged in the PQLI initiatives. In collaboration with the European Federation of Pharmaceutical Industries
and Associations, the European Medicines Agency conducted a regulator/industry event around ICH Q8, Q9 and Q10. Pfizer played
a key role in facilitating this collaborative initiative. Activities included mock regulatory inspections that were conducted
at Pfizer sites and seminars on topics that included product life-cycle management, forward-thinking action steps, and criticality.
The examples cited in this article are just some ways of how QbD is affecting the pharmaceutical industry and its regulatory
agencies on a global scale. To facilitate continuous improvement and technical innovation, the global pharmaceutical industry
needs a global quality and regulatory framework for postapproval changes. Trying to develop increasingly complicated technologies
with fewer resources than were available in the past is an ongoing challenge for the pharmaceutical industry. By enabling
pharmaceutical companies to focus on critical and promising products and process areas, QbD and other global harmonization
efforts will help the industry meet such challenges. The QbD initiatives in place throughout Pfizer are fostering the vital
codevelopment, collaboration, and innovation that position the company to meet 21st century global industry challenges. In
harmony with Pfizer's Right First Time and other continuous improvement programs and initiatives, QbD will support Pfizer's
global transformation and drive its forward growth.
Vince McCurdy is head of the Right First Time Program Office at Pfizer Global Research & Development, Gerry Migliaccio is senior vice-president of Network Performance for Pfizer Global Supply, Roger Nosal is vice-president of Pfizer Global Chemistry, Manufacturing, and Controls in Pfizer Pharmaceutical Sciences, and James Spavins is vice-president of Global Chemistry, Manufacturing,and Controls & Global Supply Chain in Pfizer Pharmaceutical Sciences.
1. FDA, "Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical
Quality of Assessment System; Notice of Pilot Program," Fed. Reg.
70 (134), 407619–40720 (July 2005).
2. ICH, Q8 Pharmaceutical Development (2008)
3. ICH, Q9 Quality Risk Management (2005).
4. ICH, Q10 Pharmaceutical Quality Systems (2008).
Note: For related article, see "Global Regulatory Submissions for QbD: Wyeth's Experience in the CMC Pilot," in the October 2009
issue of Pharmaceutical Technology.