HELEN LOWE
Auditing and Quality Assurance Director, Arriello, Dublin, Ireland

Abstract

As the global Life Sciences market experiences ongoing disruption to international supply chains, this has created turbulence and consolidation for brands and manufacturers as they grapple with the complexity of ensuring safety and quality. As companies strive to build confidence in their end-to-end safety profile, Arriello’s Helen Lowe examines how they can ensure quality without boundaries.

Throughout the drug authorisation process and right across the marketing authorisation lifecycle, licence holders are responsible for ensuring the continuous monitoring of the safety profile of a medicinal product. This includes accountability for all third parties and contractors with a potential impact on that safety profile. Relevant suppliers could include anyone from local distributors or qualified persons to IT system partners, security providers and even auditors themselves.

Disruption and turbulence in the global Life Sciences market is adding to that complexity, with changes to the line-up of suppliers and service providers, all of which affects the vendor records and controls companies must maintain to ensure end-to-end quality and safety. Where control slips, there is a real risk of problems occurring and, if these are exposed during inspections, that could lead to fines, or even product withdrawal from affected markets.

Scenarios potentially triggering an inspection could include a distributor failing to flag an effective product recall in a particular market; a local partner failing to implement additional risk minimisation mea ...