Quality Assurance: Navigating the Escalating Compliance Complexities
Pharma Tech Outlook

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Zuellig Pharma

Quality Assurance: Navigating the Escalating Compliance Complexities

Imelda Rillon

With the escalating complexity of compliance requirements and aggressive business transformation initiatives in the pharmaceutical industry, Quality Assurance is proven to be a business imperative to ensure competitiveness and success.

At Zuellig Pharma, the largest health services group in Asia, we remain focused on our mission of “Making Healthcare More Accessible”. Ensuring quality of products is a tall order in a complex supply chain network, hence, our vision transcends from accessibility to ensuring patients receive medicines of the right quality and efficacy.

We found these four factors essential in establishing Quality Assurance:

First, laying the foundation. It is important to build a robust Quality Management System which is the bedrock of any process execution. We spend significant resource in creating and maintaining a robust QMS. Our governance systems and standards are aligned to the requirements of international regulators such as the EMA and MHRA in Europe, USFDA, WHO, PIC/s and ICH as well as industry bodies such us the PDA, ISPE and ISTA. Industry trends and upcoming requirements are evaluated based on their impact to our processes and embedded into our corporate QMS. Our business units across Asia then create their standard operating procedures tightly aligned to the corporate QMS and compliant to local regulations. These SOPs are their working documents for process execution.

Second, creating a masterplan. In 2015, we started developing our Quality Roadmap spanning across a 5-year horizon and is built around three strategic pillars of People, Process and Technology. This roadmap is reviewed and updated annually keeping us on-track of our quality objectives. In 2026, we aim to be Recognized Quality Experts for Industry & Geography (People), our QMS Recognized as the Industry Reference (Process) and our Core Quality Documentation Digitalized (Technology).

"In a rapidly changing business landscape, Quality Assurance remains the anchor, ensuring procedures and strategies offer reliability and efficiency, and Zuellig Pharma continues to exploit Quality as a competitive advantage, developing customer trust and positioning our organisation for success"

Third, nurturing people. We create safe avenues for our people to share their thoughts and needs. From an informal shopfloor huddle and weekly team catchup to the more formal townhalls and organization-wide employee opinion survey, leaders effectively listen. Employee feedbacks are evaluated, action plans developed, implemented and communicated to the people.and organization-wide employee opinion survey, leaders effectively listen. Employee feedbacks are evaluated, action plans developed, implemented and communicated to the people.In Quality Department we have established a regular Individual Development Plan discussion with staff to understand their career aspirations and how the organization can provide training, coaching and other interventions to ensure they are developing towards their goal and making an impact to the overall objective of the organization. Non-QA functions are made part of our Quality Assurance Competency Certification Program, a 5-tier certification process composed of quality learning modules and project management assignments to create awareness, interest and ownership of quality across the organization.

Fourth, embarking in technology. Key to Quality Assurance is making risk-based decisions. An inhouse-application, eQMS, was developed automating key quality systems such as Deviation & CAPA, Documentation, Audit, Change and Risk management. eQMS is an enabler to our Quality 4.0 aspiration enabling predictive analytics and in the future prescriptive and cognitive for enhanced quality risk management. Business transformation initiatives employ a Quality by Design approach where Quality team is involved at project conceptualization stage to ensure compliance requirements are met.

In the rapidly changing business landscape, Quality Assurance remain to be the anchor ensuring processes and strategies deliver reliability and efficiency. Zuellig Pharma continue to leverage on Quality as our competitive advantage building customer trust and positioning our organization for success.

The articles from these contributors are based on their personal expertise and viewpoints, and do not necessarily reflect the opinions of their employers or affiliated organizations.