Building a Quality Culture Using Quality Systems
Understanding what a quality system is, and how to build one unique to your company’s culture and business needs, is fundamental to your firm’s short-term success and long-term viability. Quality systems and their relationship to corporate success is a vision shrouded in mystery for most managers. This abstract will attempt to demystify how a quality system, essential to the regulatory side of your business, can also become the roadmap for rapid product approval and financial well-being.
Quality systems are an essential part of modern pharmaceutical products and process development, human clinical trials and, ultimately, product approval. The fact that it is necessary does not mean your quality system needs to be so complex that it requires more “care and feeding” (think pets) than it is worth. The key elements of a good quality system are the following:
- Basic framework/structure in alignment with U.S. FDA regulations/guidance (think house framing)
- Step-by-step, phase-appropriate buildout of your quality system, compatible with your product/process development experience and your firm’s growth
- Just-in-time quality system that supports not only product/process development and human clinical trials but, ultimately, product approval (think “beginning with the end in mind”)
The essential elements of a quality system are rooted in the guidance provided by the U.S. FDA and ICH on adopting a comprehensive approach that encompasses all organizational facets. The distinguishing factor lies in prioritizing the selection of these six essential quality system elements and their associated metrics.
- Development (product/process)
- Engineering and maintenance (buildings, facilities, equipment)
- Manufacturing (clinical and commercial product)
- Regulatory affairs (filings and communications)
- Quality control (testing)
- Quality assurance (product disposition)
Using a good quality system approach means that regulatory expectations will be met, and your firm will have the framework and metrics to measure progress throughout your product’s development lifecycle up to and including commercialization, if that is your goal.
About the Author
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Ron Branning, GXP Quality Systems, LLC
Ron Branning has more than 50 years of experience in the biopharmaceutical industry, most recently serving SVP Quality, Chief Quality Officer, Corporate VP Quality, and Compliance Officer and Global SVP Quality. Branning has a wealth of worldwide experience establishing Quality Systems in firms producing devices, drugs, biologics, biotechnology and combination products in all dosage forms. Branning has demonstrated success in using phase-appropriate GXP Quality Systems to prepare companies for worldwide regulatory submissions and international health authority inspections that result in product approval.