Issue link: https://www.e-digitaleditions.com/i/807837
46 April 2017 Tablets & Capsules supplier compliance, contingency plans, risk management, and safety. There should also be photo libraries that clearly show excipient packag- ing, labels, and seals to help opera- tors manage discrepancies. Distributors are the last filter before a product is delivered to pharma cus- tomers, and serious excipient distribu- tors are frequently audited by their cus- tomers. Good distributors learn from these audits and elevate their quality standards. They also know and follow the Good Distribution Practices guide- lines published by the International Pharmaceutical Excipient Council (IPEC), which are a cornerstone of sound excipient distribution. ExciPact is another important group. It offers a GMP certification scheme used by quality-conscious excipient distributors and others that eliminates the need for pharma manufacturers to audit every supplier. ExciPact certification indi- cates that a distributor's practices com- ply with IPEC's guidelines and align with ISO 9001:2015 and ISO/IEC 17021-1:2015 requirements. ExciPact certification is becoming an essential global credential for excipient manu- facturers and distributors who want to reassure customers they are dedicated to pharma quality. Right now, few excipient distributors have the certifi- cation, but it will soon be the norm. We're in the process of obtaining it. Offering value beyond what's expected The future is bright for innovative excipient distributors who make sup- ply chains more efficient. An excipient distributor is, after all, a sales expert for the suppliers it represents and pro- motes. That means its staff must understand the functionality of all its excipients and their pharma applica- tions. This kind of technical expertise is important when selling to R&D staff and is the best way to be included in new projects. All of the distributor's sales executives should be trained in pharma formulation, including inten- sive hands-on training that requires them to formulate and produce tablets, capsules, topical ointments, and other dosage forms. That requires working with suppliers who are willing to con- vey their technical knowledge—on different applications and formulation troubleshooting—to the distributor's sales team. It's the kind of expertise R&D departments welcome. Too often, when pharma manufac- turers demand added value, all they get is a lower price on the excipients they buy. What they really value, however, is a strategic partner, one who can introduce efficiencies into the supply chain—and ultimately the production process—to make a man- ufacturing site more competitive. Technical expertise. To bring innovative formulation technologies into our value-added model, we cre- ated the position of technical product manager (TPM). TPMs have in-depth formulation experience from working in the R&D departments of pharma manufacturers. Their main role is to train the sales team on all the technical aspects of the products in a suppliers' portfolio and to develop a high level of technical expertise for the team. This helps create a pipeline of formu- lation projects that should result in NDA approvals and more business when production volumes grow. TPMs are part of a global team of technical experts placed in key regions around the globe to identify and take advantage of connections with related industry segments. TPMs are based in strategic markets but rely on work done at the main applications lab near Cologne, Germany, which provides suppliers with support to develop new uses and grades of existing excipients, as well as opportunities to find new ones to help deliver innovative thera- IMCD Group, which acquired Mutchler Pharmaceutical Ingredients last July, opened its first pharmaceutical applica- tions lab in Germany in October 2013.