New Requirements for Excipients
Patricia Rafidison, Global Regulatory Compliance Manager, Dow Corning
A: Excipients represent a broad diversity of substances. Therefore, appropriate Good Manufacturing Practices, based on IPEC guidelines or equivalent, should always be considered and preferably coupled with using a risk-based approach in order to meet current and future industries’ expectations. Many excipients are also handled by distributors, and it can be challenging to establish full traceability in order to ensure product integrity. Consequently, it is necessary for drug companies to assess the quality of the supply chain depending on the type of supplier, the excipient technology, the distribution channels and the intended use. While they may purchase many excipients from multiple suppliers, a one-size-fits-all approach isn’t, in many cases, practical. In addition, suppliers will be carefully considering any actions they must pursue that require extensive investment. Finally, lack of harmonization of requirements around the world adds significant complexity for excipient suppliers and drug manufacturers alike. Overcoming these challenges requires good cooperation and two-way communication between both parties, which in turn requires building of trust — something that does not occur quickly or easily.
William van den Bremer, Global Supply Chain Manager, DFE Pharma
A: Per the IPEC guidelines, all parties in the supply chain share the responsibility to ensure the quality and safety of materials and products. However, in the end, the drug manufacturers have the responsibility for setting up a risk-management program that assesses risks in their downstream supply chain. The large and globally extended networks of suppliers make it a challenge for drug manufactures to implement risk-management programs efficiently across their supplier base. Working with fewer preferred suppliers that can offer full control and transparency over their downstream supply chain can decrease the effort required to meet the new requirements for drug manufacturers. However, it can also restrict the availability of excipient suppliers meeting the standard. An additional trend is the increased regulatory focus on drug availability that is pushing drug manufacturers to critically assess business continuity with their critical suppliers. DFE Pharma supports drug manufacturers by having our own business continuity plan, including supply chain mapping and risk assessments for our manufacturing network and suppliers.
Ramesh Subramanian, Ph.D., VP, Strategic Marketing and Global Head, Business Development, Piramal Discovery Solutions
A: There are various challenges ranging from batch sizes and minimum order quantity to quality inspection and financial stability of these companies. The greatest of all would be supply chain issues of low-volume excipients where the manufacturers have set campaigns in the year and any miscalculation would be detrimental for supply in the market. Identifying these excipients to have a supply chain risk mitigation or de-risking plan in place is critical for a drug manufacturer.
Dirk Hair, Technology & Innovation Manager, Product Development Medical and Pharmaceutical, Celanese
A: These requirements are resulting in an increased number of audits by the drug manufacturers’ audit teams, with increased scope. As an excipient supplier that is highly responsive to emerging requirements, this change provides further evidence that our customer-driven engagement model meets or exceeds these evolving requirements.