Marketing authorisation holders’ responsibility for ensuring the continuous monitoring of the safety of a medicinal product across the marketing authorisation lifecycle includes accountability for all third-party suppliers with a potential impact on that safety profile. Arriello’s COO, Anna Lukyanova, provides practical tips for maintaining a robust safety profile through tighter controls right along the supply chain.
The global Life Sciences supply chain has experienced unprecedented turmoil recently, creating a challenge when it comes to ensuring end-to-end quality and safety. Suppliers could include anyone from local distributors or qualified persons to IT system partners, security providers and even auditors themselves. Increasing changes to suppliers and service providers affect the vendor records and controls companies must maintain to ensure end-to-end quality and safety.
If control issues 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risk minimisation measures (aRMMs); or a local qualified person being unreachable by the relevant authority due to out-of-date contact details or the vendor going into liquidation.
Regulators are expected to issue firmer guidance on vendor management controls sooner rather than later. In the meantime, robust vendor management is an expectation under EU GxP requirements. So, if drug developers or licence holders fall short, they could risk their reputations as well as significant fines and ultimately product withdrawals.
Start by Creating a Definitive List
To address this issue, it’s important to start by identifying ALL suppliers with a potential bearing on a product’s safety profile, however tenuous. Once a definitive list has been compiled, each supplier can be reviewed for potential risk/safety impact and appropriate due diligence. (Ideally, such factors should form part of the risk-based evaluation conducted before entering into a contract with a new supplier or service provider.)
Suppliers range from sales and marketing companies which capture data and could come across adverse events (AEs); outsourced service providers – e.g. of data management; biostatistics; medical writing; pharmacovigilance (PV) service providers; IT providers that host the company’s safety database or ensure the safety data being stored; and independent PV or Clinical Safety contract auditors. Then each third party can be assessed for potential safety profile impact, the current supply/contract status and any monitoring, and required next steps.
Vendor and Quality Management
Go Hand in Hand
A robust vendor management system (VMS) is every bit as important as a robust quality management system (QMS). Ultimately it should form an integral part of the QMS, and awareness, training and buy-in to vendor management practices should be formalised with appropriate communication and training