Quality & Validation

A Holistic Approach to Quality and Compliance in Biopharma Development

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Advanced Clinical Quality & Compliance Team
Advanced Clinical Quality & Compliance Team

In the ever-evolving landscape of biopharmaceutical development, the challenges of working in an internationally growing company are both exciting and complex. As companies expand globally, maintaining effective communication and upholding stringent quality and compliance standards become paramount. For small- and mid-size pharma companies, as well as emerging biotech companies, the journey of growing and expanding into new geographic regions necessitates a holistic approach to quality and compliance. It's about building a system that stands the test of time — a system founded on bedrock principles of communication, quality training and quality management.

Communicate. Consistently.

Navigating the challenges of maintaining communication in a globally dispersed organization requires strategic thinking. Effective communication on a global scale is not just a nicety but a cornerstone in ensuring a smooth and error-free quality management system (QMS). Clear communication is the linchpin from general tasks to noncompliance management, audit management and training management.

Audit management poses unique challenges, especially for internal staff juggling multiple audits simultaneously. The key lies in preparation. As auditors schedule audits, the preparation process begins, confirming audit scope, length, and remote possibilities. Communication between quality and compliance and project teams is pivotal. Multiple prep meetings ensure alignment, minimizing last-minute scrambling and ensuring a smoother audit process.

Behind the scenes of audit preparation lies a meticulous process. From confirming audit details to scheduling prep meetings and reviewing prior audit findings, the journey toward a successful audit is paved with proactive communication, thorough documentation review and strategic planning.

Training is the bedrock of quality assurance within any organization. Yet, tracking training efforts and preventing deviations from standard practices can be challenging. Auditing becomes the compass to navigate this terrain. Regularly tracking and auditing training programs not only ensure compliance but also provide a clear and concise view for auditors or regulatory authorities.

The steps in training preparation are critical. Regularly reviewing training records, ensuring documentation is clean and concise, and having procedures in place for ongoing project review are vital components. Quick access to up-to-date information is crucial for maintaining regulatory/GCP compliance.

Are Small and Mid-Size Biopharma Companies Equipped?

As these companies navigate challenges, partnering with an experienced partner becomes not just beneficial but often necessary. Small and mid-size biopharma companies may lack the in-house knowledge and expertise needed to develop a thorough system that adapts to the evolving regulatory landscape. From managing audit requests to training programs, many small companies often handle these processes passively, responding only to immediate needs. However, a paradigm shift is needed. Strategic and holistic thinking is imperative for ensuring long-term quality and compliance. Regulatory compliance obligations change across study phases and countries, requiring a proactive approach to building and scaling customized quality management systems that stand the test of time.


In conclusion, the journey of navigating global expansion in biopharma development is multifaceted. Key learnings encompass the importance of holistic quality management systems, effective communication, meticulous audit management, and robust training programs. Adopting a strategic, long-term perspective is not just a best practice; it's the foundation for success in an industry where adaptability and foresight are paramount.


The Authors

  • Fauziyah Akhtar, Compliance & Quality Manager
  • Lauren Gonter, Quality Auditor I
  • Mackenzi Truelove, Quality Analyst

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