The Raw Material Risk Management workstream has launched a new, raw material risk assessment tool aimed at helping industry identify and prioritize around the challenging question of material fit.
In our high-stakes, highly regulated environment, as suppliers and manufacturers strive to meet a perpetual tide of new “regulatory standards, the supplier-biomanufacturer relationship can become strained. This new tool standardizes and structures the risk assessment process, thereby improving communication between – and within – manufacturers and suppliers.
“Intricate differences in raw material fit-for-function requirements in biopharma present a significant challenge to risk standardization. Essentially, “like-for-like” doesn’t really exist.”, comments Kara S Quinn, Associate Director at Merck & Co Inc Kenilworth, NJ, and the lead author of an extensive new paper entitled Raw material risk assessments: a holistic approach to raw material risk assessments through industry collaboration. Indeed, it would be 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. It is the product manufacturer’s responsibility to maintain the qualified status of the raw materials, as well as to decide the stringency with which good manufacturing processes should be applied.
“Risk assessments improve understanding of risk differentiation in terms of likelihood to occur and ultimate impact,” says Kara, continuing through persistent collaboration and a shared desire to advance, the team set out “to develop an adaptable, evidence-based methodology to deliver an industry-aligned, practical tool for the proactive prioritization of proportionate risk.”
The new tool takes users systematically through the process of 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?
- Are there reliable supply chains in the marketplace to help address the first two questions, by providing materials of reasonable quality?
The tool is based on a common set of raw material attributes, uses industry-aligned examples of high, medium and low risk and includes a methodology to determine proportionality of risk. It is adaptable to organizations of all sizes and is flexible enough to allow for differing scales of risk tolerance. As a result, users are well placed to make uniform, evidence-based decisions on risks and priorities concerning raw materials.
The new tool and accompanying interactive worksheets are simple, straightforward and effective. Ready to use today, this risk-assessment method is based on scientific fact. However, like an iceberg, beneath the surface is a hidden mass of cumulative expertise, hard work, and collaborative development. The new paper Raw material risk assessments: a holistic approach to raw material risk assessments through industry collaboration, delivers:
- a holistic approach to risk assessment of all raw materials
- common attributes to consider
- shared examples of high, medium and low risks
- criteria for determining misalignment of function
- methods of quantitative/comparative analysis
- suggested timings and frequency of assessment
- a worksheet for knowledge management
- detailed case studies
At the start of the project, when a workstream survey indicated the overwhelming majority favoured a standardized, risk-based approach, the team, led by Kara and Chiali Liu (Janssen Pharmaceutical), realized the enormity of the task ahead – this was not for the faint-hearted. It is little wonder that at the end of the project, the team chose to acknowledge their BioPhorum Facilitator, Julian Goy, as ‘fearless’ for ‘giving the team the time and focus to align our efforts and work through the debate at a defining moment.’ The result will be to the benefit of the whole industry and ultimately the patient.