risk management


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Driving industry consensus on the EU’s Medical Devices regulation

The EU Medical Device Regulation (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...

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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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How to replenish working cell banks with a risk-based scientific approach

Cell banks represent the fundamental starting substrates for biological drug substance/drug substance intermediate manufacturing. So, the availability of well-characterized cell banks capable of supporting manufacturing processes is critical for an uninterrupted drug product supply to patients and global markets.  This is why two-tier cell banking systems are developed, consisting of master cell banks and...

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How do you manage risk in your supply chain?

The biopharmaceutical supply chain is global and complex, and disruptions can quickly have an impact – you only have to look at COVID-19 to see the importance of maintaining surety of supply. So, it is critical that manufacturers, tier 1 suppliers and their sub-tier suppliers understand the risks in their supply base and deploy effective and consistent risk management systems to reduce their exposure to problems. Unfortunately, a range of...

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Isolator glove management evaluation of regulatory guidance and framework of recommendations

The loss or delay of a batch for glove failure and uncertainties of glove management are perennial concerns for aseptic filling operations. Written by a team of industry practitioners who create, justify and manage glove programs, this guide defines current best practice and the actions we can all take to reduce risk. Specifically it enables users to understand glove-related risks, facilitating deviation investigations and building confidence when presenting to inspectors. Helps users understand the rationale for supplier recommendations about glove lifecycle management. Reduces the need for users to develop their own glove lifecycle management strategies and standardizes the language for collecting data in and across companies, that will support future benchmarking and improvement.

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Raw material: A holistic approach to raw material risk assessments through industrial collaboration

It is impossible to define the raw materials used in the biopharmaceutical industry with a single set of regulatory or compliance criteria. What is considered fit-for-function changes depending on the product attributes and the intended customer. This tool standardizes and structures the risk assessment process, addressing three fundamental questions when determining raw material fit-for-function: What user requirement is the raw material designated to perform? What material attributes are essential to the designated function and what might have unintended consequences? This paper helps improve communication between – and within – manufacturers and suppliers and enables users to make uniform, evidence-based decisions on risks and priorities concerning raw materials. An industry-wide methodology for the resolution of high-impact raw material variability issues.

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Product changeovers (PCO): Guidelines for risk based changeover of biopharmaceutical multi-product facilities

Product changeover is a process that prepares and configures the facility and equipment for the next manufacturing process, and includes actions taken to protect the subsequent process against contamination from the previous process. Historically, the change-over between two products within a multi-product facility has created a great deal of operational inefficiency. This paper shows how with the use of risk-based tools and supporting data, the changeover activities of multi-product facilities can be significantly reduced and, under well-controlled and characterized operations, concurrent manufacturing may be achieved. Specifically, the change-out of small parts and elastomers as well as the collection of changeover cleaning samples may be significantly reduced or eliminated. This article is primarily intended for the manufacture of bulk biologic drug substance; however, the principles may be applied to finished drug product as well.

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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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