A dynamic global life sciences market, coupled with disruption to international supply chains, has seen new turbulence and consolidation for brands and manufacturers – both at an industry level and third-party suppliers. This is adding multiple layers of complexity in terms of the controls companies have in place to ensure end-to-end quality and safety. Arriello’s Helen Lowe considers how drug companies can ensure quality without boundaries and build new confidence in their end-to-end safety profile.
Key insights:
- Licence holders are responsible for ensuring the continuous monitoring of the safety profile of a medicinal product throughout the drug authorisation process and the marketing authorisation lifecycle.
- Each potential third party should be assessed for potential safety profile impact, the current supply/contract status and any monitoring, and required next steps.
- Everyone in the organisation should be aware of the vendors used so that if they become aware of any related developments, they can report them to safety/PVQA to investigate the potential risk of those changes.
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.