The impact of sourcing selections is indisputably significant. In fact, one can argue that procuring raw materials for manufacturing is the first step in aligning your supply chain to reflect your company goals as well as managing your risk. As a result, it is imperative to source carefully and knowledgeably. When developing a supply chain strategy, it is critical to take patient safety into primary consideration. A careful understanding of this goal will prove beneficial for any life science manufacturer.
Patient safety is a crucial responsibility of the pharma industry and it all starts with raw material selection and qualification. Even trace amounts of contamination in raw materials can impact the quality of the final drug compound and result in many sick patients. In 2008, we all remember what happened with a widely used blood thinner used in surgery. Heparin, a key material that was sourced from China was tainted. It turns out that sophisticated lab tests later determined it to be a chemically modified substance that mimics Heparin. The United States Food and Drug Administration linked this bad batch to 19 deaths and hundreds of severe allergic reactions.
After many near misses, the heparin scare has eliminated any doubt that,both here and abroad, regulatory agencies overseeing the safety of medicine are overwhelmed in a global economy where supply chains are long and opaque, and often involve many manufacturers.
In order to source raw materials and excipients for patient safety, one must determine the necessary quality level for each raw material component. Identifying a product’s grade and specifications is the most concrete way to indicate a raw material’s quality. Knowledge of where the material is used in the production process and what the final product is will largely determine the material grade needed. In order to minimize risk, complete understanding of the supply chain security in each step of the process is a key factor. Supply chain transparency couples with this as well, as not is it important to know each link along the way but exactly where the products originate in order to assess the weaknesses of the supply chain.
Additionally, the quality of a raw material is driven by the production processes of the selected supplier. Carefully controlled production processes that are run under carefully regulated cGMP’s eliminate the possibility of adulterated material. However, this is often more expensive and, occasionally, unavailable for select material. If cost is a concern or GMP production is unavailable, an alternative option that still assures high-quality material would be reprocessing under cGMP’s. In this situation, the material is produced in a non-GMP environment first and then undergoes reprocessing under GMP’s. On the other side of the spectrum are materials that do not undergo any kind of GMP production or reprocessing. Although the price is typically attractive with this option, it is largely questionable as to whether tests are accurate and validated. In choosing these materials, the risk for contamination is significantly augmented.
The production process alone, however, does not define overall supplier quality. There are several hallmarks of a quality supplier that should also be taken into consideration when sourcing. It is crucial that a supplier follows a documented quality system and has a quality program in place for its own raw materials. Furthermore, a dependable supplier should have passed FDA or other regulatory audits and also successfully pass your company audit. Other things to look out for are whether supplier can reliably provide lot control, if there is a stability program in place to determine shelf life, and if there is a reliable mechanism for management of change. Although there are other factors that can further assess a supplier’s quality, these hallmarks are a good start to ensure that you are sourcing from a dependable supplier.
Ultimately, to ensure patient safety goals, it is important to measure raw material quality in a variety of ways. Knowledge of what grade is needed, what production processes are performed, and the overall reliability of the selected supplier will significantly augment your ability to source a raw material that ensures operational efficiency.