Strategies To Achieve Success In Your Regulatory Inspection

By Jo Beth DeFreitas and Eunah Yoh, Samsung Biologics

The new drug development journey is a long, complex, and rigorous process. Every step is aimed at bringing effective medicines to patients as quickly as possible while ensuring the highest level of quality and safety, as well as ensuring regulatory compliance. A fast-changing and increasingly complex global regulatory environment has pushed the industry to develop new skills, improve the use of innovative technology, and adopt new operation models.

Overcoming these challenges demands that biopharmaceutical companies and their partners establish synchronized, risk-based approaches to regulatory navigation. Facility audits or inspections can be among the most demanding, yet critical, interactions a biopharma has with regulators. However, preparation, practice, and the guidance of a knowledgeable partner ease this task considerably.

Regulatory inspection preceding product approval comprises an intense process that can span days or weeks as inspectors scrutinize each production site’s equipment, facility design, pathways, employee training, documentation, and more.