When bringing a new injectable drug product to market, the packaging is quite important, especially considering the potential problems that can result with stability, manufacturing, or use. In today’s regulatory climate, it is essential to have a heightened awareness of all the risks that can occur, from development through lifecycle. This article will cover four pitfalls to avoid when packaging drug products.
Use of Legacy Components or Systems for Today's Drug Products
Many manufacturers of new drug products, in particular biologic drug products, use legacy components for packaging, i.e., components they have used over time and with other drug products. This is based on the assumption that packaging components are inert, or that issues can be overcome by reformulation. These legacy components appear to offer the benefits of known performance and supply chain and resultant smooth production with minimal downtime. But legacy components may not meet the quality and regulatory standards of today, which require understanding of potential risks for each individual pairing of drug product and container closure system (CCS). In particular, an understanding of the factors that impact protection, compatibility, safety, and performance, is required.
For example, an ongoing risk to injectable drug products is particles in solution. Particles can result through many ways, such as various incompatibilities, contamination sources like production environment, or insufficient washing. An awareness by drug manufacturers of these issues is essential, particularly knowledge of new options in CCS packaging components, and their ability to mitigate particle issues and help to meet the rigorous quality and regulatory standards of today.
Lack of Innovation Adoption
This pitfall relates to Pitfall-1, although the industry is very interested in innovations, their ability to adopt them is quite slow. The "pain" resultant from non-adoption must be quite visible throughout an organization in order to gain the alignment by all functions needed to drive adoption of an innovation. Of course, there can be major advantages for those who are first movers and are willing to engage in the activities needed for adoption of innovations. This can be greatly promoted through partnerships with the suppliers/owners of a platform or technology. Suppliers can help guide critical product requirements without the drug manufacturer needing to fund a specific development program; suppliers receive useful input from the manufacturers to assure a product will meet industry needs.
One might argue that the barriers to innovation adoption lie in the drug R&D process itself, particularly in the way that scientists and engineers relate to supporting functions such as information technology, intellectual property, legal, procurement/supply chain, operations, regulatory and quality assurance. Ultimately, innovation may be blocked by individuals who cannot exchange information in an understandable way among the various functions, resulting in an inability to convey the importance of the innovation. This challenge, coupled with the frequent lack of clarity as to decision making ownership, and the normal risk aversion due to potential regulatory challenges, is central.
Lack of Awareness: Components May Be Part of a Combination Product
There is an increasing awareness, especially among device engineers and regulatory personnel, on the subject of drug/device combination products, in particular the Quality System regulations specified in 21 CFR 820. The challenge, however, is that historically the industry has been focused on the drug product and package – not the delivery device. Therefore, there was limited understanding of the technical, developmental, and regulatory requirements to meet current combination product best practices, which means combining both the drug and device CGMP regulations. In fact, until the last several years, there was still confusion around the fact that prefilled syringe systems are combination products. This is now noted in several areas on the FDA website and associated combination product guidances. Building this type of awareness take...
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