Raw Materials: Supplier change notifications: change areas and requirements

Change control and periodic re-assessment are an essential part of raw-material lifecycle management to maintain a qualified raw material. In addition, accurate and timely information is also required in risk assessment to identify any raw materials that warrant mitigating action. The industry standard on raw-material risk management (https://www.biophorum.com/a-new-tool-for-assessing-raw-material-risk/), published by BioPhorum in 2019, gives an aligned industry perspective on the risks associated with raw-material qualification in biopharmaceutical manufacturing as well as a step-by-step adaptable method to assess raw-material risk. The BioPhorum tool also highlights some of the most impactful characteristics for raw materials; which translate to the type of characteristics the biopharmaceutical industry is most interested in understanding with respect to supplier changes.

The challenge for the industry is how to manage the large volume of supplier change notifications (SCNs) while ensuring a compliant and uninterrupted supply of materials for production. Many resources are dedicated to managing SCNs in the pharmaceutical industry, especially given that companies may have to manage several hundred SCNs per year, potentially covering several hundred materials from a complex supply chain of manufacturers, packagers and distributors. In addition to the volume of changes submitted by suppliers, there is also an extremely wide variety of information that a supplier provides, relating to content, format, and details within these changes. However, in many cases, the level of detail provided is still insufficient for the pharmaceutical company to understand the scope of change, and to determine if there is any impact to pharmaceutical product. Withinthe industry, the varying level of detail and content provided by suppliers creates additional work to understand what is truly changing.

The process is equally frustrating for suppliers to the industry, who are inundated with a multitude of requests for additional information from end-users. This means that suppliers are also required to dedicate extra resources to fulfill differing requests from individual organizations. In some cases, the additional burden of data collection and provision causes delays to implementing changes and a need to build stock of pre-change material exclusively for the industry. In the context of this unsatisfactory situation across the whole supply chain, the BioPhorum Raw Material Variability workstream identified a need for a collaborative, consistent approach to managing supplier-initiated changes sent to biopharmaceutical manufacturers. This guidance document identifies the relevant change areas, and for each area, exemplifies the type of changes which the biopharmaceutical industry needs to be informed about. It also lists the required information, in terms of supporting data and documentation, to support notification of changes. This guidance is relevant to all raw materials used to produce biopharmaceutical products, including but not limited to cell culture media, fermentation broth components, column resin, buffers, solvents, and excipients.

By highlighting the changes biopharmaceutical industry end-users need to know about and specifying the information required, the intention of this industry-aligned guidance is to reduce the quantity of rework required and the time taken to process change requests. In turn, this will reduce variability in demand patterns as end-users refrain from building extensive inventories to mitigate against the perceived risks which arise from proposed changes. While complete alignment and standardization on the information which should be provided for changes is not possible, a more robust alignment on the typical information required, as set on in this guidance, will significantly improve the current state.

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