New Requirements For Excipients

William van den Bremer, Global Supply Chain Manager, DFE Pharma

A: The need to generate full supply chain transparency will lead to increased scrutiny of excipient suppliers’ supply chains. The level of involvement and oversight required to get excipient suppliers to provide the right transparency depends on the specific characteristics of the suppliers. Adapting to the new standards might be more challenging for smaller or nondedicated pharmaceutical excipient suppliers (many suppliers also have food, cosmetic, etc. products in their portfolio) and will require a more involved approach from the drug manufacturer. In the end, the new requirements will force drug manufacturers and excipient suppliers to work together more closely in solid, open partnerships.

Dirk Hair, Technology & Innovation Manager, Product Development Medical and Pharmaceutical, Celanese 

A: As an excipient supplier, this change is bringing more consistency and alignment in requirements from the drug manufacturers, and an opportunity to further enhance our service model. Changes related to Good Manufacturing Practices (GMP) and supply chain have been further enhanced by the release of standards specifically for excipient manufacture, such as NSF/IPEC/ANSI 363–2014 GMP for Pharmaceutical Excipients.

Patricia Rafidison, Global Regulatory Compliance Manager, Dow Corning

A: Drug manufacturers need to gain a higher level of understanding of their total excipient supply chain, more so than they have in the past, which requires more knowledge of supplier manufacturing practices, quality programs, regulatory capabilities, logistics, etc. Risk assessments must be performed to determine the appropriate level of expectations based on each excipient and its intended end use. Suppliers must then be evaluated to identify any gaps and mutually agreed plans developed to address them. Such activities require close cooperation between suppliers and their pharmaceutical industry customers. Formal quality agreements are often one end result.

The industry has also been active with respect to the development of clear guidelines and tools to facilitate the process and help suppliers and drug manufacturers systematically perform these assessments, put appropriate practices in place and document their activities. One direction that needs to be worked on is standardized supplier information packages such as questionnaires and quality agreements that can eventually be developed to further simplify and harmonize the process for both parties.

Ramesh Subramanian, Ph.D., VP, Strategic Marketing and Global Head, Business Development, Piramal Discovery Solutions

A: The impact will be on time and cost both. Currently, as far as FDA submissions of finished forms are concerned, the need is to have U.S. DMF-approved excipients. So in a way, the quality and GMP aspect is taken care of. But beyond ensuring that the source is a U.S. DMF-approved source, the formulation manufacturer has limited knowledge of the supply chain for the [excipients]. Deeper understanding of the supply chain here will help manage the supply of finished dosages well. The same becomes critical when it comes to a global project when there are a limited number of suppliers for excipients that cater to the GMP and quality standards of a wider regulatory requirement of different countries. It is only prudent to consider the excipients of primary packaging material in the same context. Usually, this is an oligopoly market with fewer large suppliers controlling this market — examples: resins, polymers, etc.