Maximising supplier controls to ensure optimal quality and safety

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risk minimisation measures (aRMMs); or a local qualified person being unreachable by the relevant authority due to out-of-date contact details or the vendor going into liquidation.