Building a Quality-Driven Culture to Lead in Regulatory Excellence

At West, quality is more than a promise or a regulatory requirement — it's the foundation of everything we do to ensure we meet and exceed our customers' expectations while working to improve patient health. We recently rolled out a new Quality Policy across our organization, which highlights West’s commitment to a culture of excellence, emphasizing safety, sustainability, and continuous improvement.
By embedding quality into every aspect of our operations, West has established trust while also staying ahead of evolving regulatory requirements and Good Manufacturing Practice (GMP) standards.

Our policy underscores the internal Quality Culture at West, which empowers team members to lead in quality, be accountable, drive continuous improvement, and always focus on patients and customers. Our dedication to quality is unwavering, and as a leader in the life sciences industry, we uphold these principles as the foundation of our operations and growth.

Implementing the Policy: A Unified Effort

The successful rollout of our new Quality Policy has been a collective effort encompassing diverse communication strategies and leadership involvement at all levels. To ensure that every team member understands the significance of this policy, our leadership has actively engaged in several initiatives:

• Global Leadership Engagement: Eric Green, our President, CEO, and Chairman of the Board, addressed the policy at a global all-employee business forum. His endorsement underscores the importance of the policy within our organizational framework.
• Quality Leadership Communication: Our Chief Quality and Regulatory Officer, Kathy dePadua, took the lead in discussing the Quality Policy during all quality Townhalls across the globe, fostering an open dialogue and addressing any questions from the team.
• Internal Communications: Strategic internal communication has been a key tactic for driving comprehensive insights into the policy changes emphasizing our collective commitment to quality as One West Team.
• Visible Implementation: The policy is displayed at all locations globally, with translations available, to facilitate understanding of all team members.
• Local Engagement: Our manufacturing sites have been proactive in driving awareness through town halls and local communications, reinforcing the critical role every employee plays in embodying the policy’s principles.

Maintaining the highest standards of product quality is crucial for our ongoing success, ensuring that it remains a shared responsibility across the organization.

Staying Ahead of Regulatory Change

The regulatory landscape for the injectable medical device industry is complex and constantly shifting. Along with our quality-first culture, we have established dedicated cross-functional regulatory and quality teams who:

• Monitor evolving requirements from global regulatory bodies such as the FDA, EMA, and MHRA.
• Interpret GMP updates, including the comprehensive revision of EU GMP Annex 1 on sterile product manufacturing, into actionable insights for production, engineering, and quality teams.
• Host internal knowledge-sharing forums where employees can learn, discuss, and apply new requirements.
• Reinforce contamination control best practices with ongoing training and internal communication campaigns.

For example, with the revised Annex 1 placing heightened emphasis on contamination control strategies, West has proactively strengthened its cleanroom design, environmental monitoring, and aseptic process validations. This early adoption not only ensures compliance but also sets a higher internal standard for product safety. Additionally, West actively contributes to the broader industry by publishing white papers and participating in panels about regulatory trends, GMP best practices, and the practical implications of Annex 1.

A Call to Action for Continuous Commitment

As we roll out this pivotal Quality Policy and continue to focus on being a leader in regulatory change requirements, we commend our teams for their dedication to excellence. Our Quality Policy demonstrates our resolve in making quality a shared responsibility, highlighting how together, we can achieve remarkable outcomes for the patients and customers we serve. Learn more about Annex 1 and the impact on your primary packaging here.

Important product and safety information and warnings for SmartDose and SelfDose, respectively, available at: