risk management


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Implementation of Article 117 of European Union Medical Devices Regulation (EU MDR) General Safety and Performance Requirements: a position paper

The EU MDR Article 117 became legally binding and mandatory in May 2021, but there is no clear industry consensus regarding its application to integral drug delivery devices. The regulation is particularly unclear in the case of a device constituent part being classified as an invasive device, and whether all drug product contacting components must conform to the requirements for invasive components. There are also ambiguities regarding requirements such as notified body opinion and human factor study requirements. This paper presents an industry position statement and illustrates the concerns.

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Risk and Business Continuity: Risk management in the biologic industry supply chain

This best practice guide to risk management in the biologics industry supply chain is based on the premise that adoption and implementation of the principles and framework reflected in ISO 31000 (Risk Management: 2018) provide an effective and efficient way to support biologics industry growth while maintaining, and potentially increasing, benefit to patients and companies, in addition to satisfying the demands of regulatory agencies and meeting legislative requirements. It is designed to encourage the industry to review their approach to risk management to validate, or refine and improve, current company practice, in terms of principles and risk management processes in this vitally important business function.

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Supply chain mapping: A best practice for the biopharma industry

The complexity of the support networks needed to deliver biopharma products, makes good supply chain mapping (SCM) essential to ensure reliable drug product supply.  This is especially the case given the impact that natural disasters, adverse weather and politics can have on supply chain security.

This guide from the Supply Chain Mapping workstream can be tailored to the needs of both suppliers and manufacturers and helps them map and master supply chain risk.  The guide details reasons why companies should adopt the approach, an implementation model, a standardized questionnaire to collate and manage basic supplier data and a maturity model against which a company can assess its own level of supply chain mapping and understanding.

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Raw materials: Patient-centric requirements for the supply of raw materials

Raw material variability and control in the supply chain are important matters for the biopharmaceutical industry. The industry is still working to align the supply performance with biopharma’s needs. More still needs to be done to understand, monitor and control of raw materials. Patient well-being is best assured by reducing or eliminating variability of the finished drug product, and this can be achieved, in part by targeted reduction and/or elimination of variation in raw materials. This paper identifies ten areas of practice endorsed by leading global biopharmaceutical manufacturers to start to address and reduce raw material variation through our supply chains.

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