Raw Material Change? When were you planning on telling me?!
It’s a given that the quality of raw materials impacts the quality of biopharmaceuticals. When manufacturers change the processes to produce raw materials, release testing is conducted to confirm that the materials still meet specifications. However, these specifications are based on the supplier’s notion of the critical quality attributes. Identifying the critical quality attributes of a raw material requires an understanding of the relationship of the raw material and its impact on the quality of the drug being produced. However, early in development, biopharmaceutical companies cannot always identify critical attributes. Without this knowledge, the developer cannot evaluate the impact of raw material changes on product quality. Given the potential for unforeseen effects of raw material changes on a biopharma manufacturing process, how can the customer ensure that suppliers inform them when important changes in production or testing are made? Two-way communication is key.
Raw material suppliers understand their products and test to specification, but changes in their manufacturing processes, which they may not view as significant, may have a major impact on their customer’s product quality. For many customers the only communication of a raw material’s attributes may be the Certificate of Analysis shipped with their purchase. Can a customer reasonably expect notice of every change a raw material supplier intends to make before the chance is made? Can the suppliers afford to inform every customer about every change? One approach customers can implement is to develop quality agreements with material suppliers whose products have a high probability of impacting product quality. However, for small, early stage drug developers the solution may not be this straightforward as they may lack the knowledge and resources to address the issue. Yet, risk assessments and information networks may be two useful tools for early stage product companies to help identify the critical materials within their supply chain.
One recent example of an information network is the June 2011 symposium convened to discuss the problem of glass delamination. Present were representatives from the pharma and biopharma industry, glass manufacturers and representatives from the FDA and USP. In summarizing the results of the RX-360 Symposium, one of the key points identified was the need for improved communication and partnering between glass suppliers and pharmaceutical manufacturers. Specifically, customers and suppliers need to openly communicate on glass manufacturing processes, aspects of glass formulations, and aspects of (bio)pharmaceutical formulations.
Clearly, the customer cannot expect the raw material supplier to understand all their needs for a particular material. But neither should the supplier assume that the testing they provide is sufficient for all customers. Biopharma companies are relying on an ever-increasing range of suppliers for raw materials and disposable processing components. As the biopharma supply chain increases in complexity, so does the need for a true, information-sharing partnership between customers and suppliers.