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

This paper A holistic approach to raw material risk assessments through industrial collaboration and supporting tool is 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. 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

The  tool takes users systematically through the process of addressing three fundamental questions when determining raw material fit-for-function:

  1. What user requirement is the raw material designated to perform?
  2. What material attributes are essential to the designated function and what might have unintended consequences?
  3. Are there reliable supply chains in the marketplace to help address the first two questions, by providing materials of reasonable quality?

It 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 tool is simple, straightforward and effective. Ready to use today, this risk-assessment method is based on scientific fact. The paper 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

In addition in a companion piece in American Pharmaceutical Review article, Quinn takes a light-hearted look at the role of raw materials in medicinal product manufacturing, outlines the role of the BioPhorum Drug Substance Raw Materials Workstream and outlines the paper (and says “If A.A. Milne wrote of the hundred-acre biopharmaceutical facility, raw materials would inevitably play the role of Eeyore.”).


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Raw material risk assessment toolkit September 2020.xlsx
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