Issue link: https://www.e-digitaleditions.com/i/807837
Tablets & Capsules April 2017 49 from bulk, weighs them, adds a label, and inserts the required documents into the outer package. Everything could be done as a GMP-compliant, continuous process. Conclusion The role of excipient distributors is expanding and those that adapt have a bright future as value-added contribu- tors to both pharma manufacturers and excipient suppliers. Both ends of the chain rely on the conduit in the mid- dle. In the future, distributors will have even more influence on what excipi- ents are used in formulations and in providing production efficiencies. Distributors who offer what I've described above will become indis- pensable to pharma manufacturers and excipient suppliers seeking superior service, value, and market reach. T&C Dwight Mutchler is president, USA and Puerto Rico, of Mutchler Pharmaceutical Ingredients, a unit of IMCD, 20 Elm Street, Harrington Park, NJ 07640. Tel. 201 768 1100. Website: www.mutchlerinc.com. IMCD, based in Rotterdam, Netherlands, acquired Mutchler Inc. in July 2016. Samples. The rule of thumb is, "There has never been an order for a new excipient without a sample." Offering samples to R&D customers is imperative for gaining approval for use in production. That's why excipi- ent distributors must keep ample in- house samples of all the products in its portfolio. In addition, all samples must have sufficient shelf-life, be correctly labeled, and provide lot traceability via valid certificates of analysis. Most customers request samples in groups of three, each from a separate lot, so variances can be measured. Excipient manufacturers don't always get this protocol right, which can waste time and the sales opportunity. Excipient distributors can help get it right. Furthermore, most samples aren't packed under GMP conditions. This is done purposely to deter customers or prospective customers from using them in marketed products. Here, too, the distributor can help by repacking bulk excipients into sample sizes under GMP conditions to main- tain the product's integrity. This prac- tice could become the norm for sam- ple packaging. In fact, it could lay the ground work for automatic dispensing machines: When a request is received, the machine retrieves fresh samples pies. Suppliers and our customers in R&D departments appreciate this added value from their distributor. Though rare today, this model of pro- viding technical resources to the sup- ply chain is likely to spread. Customization. For years, distribu- tors have studied the pre-production process to learn how to inject value beyond price and logistical efficien- cies. What we discovered is that many pharma manufacturers don't know the true in-house cost of ownership of an excipient, only the delivered per-kilo price. In response, we launched Added Value Services (AVS), a division that supplies production-ready excipients in custom repackaging and weights and that are tailored to allow cus- tomers to add the excipients directly to the production hopper. Offering excipients this way was only possible by instituting the same practices our pharma customers use, including oper- ating under strict GMP protocols, keeping batch records, and working in validated cleanrooms. As a result, the distributor can become part of the production process, offering specialty packaging that excipient suppliers maybe cannot. The value comes from eliminating tedious in-house prepara- tion and accelerating cycle times to reach the market faster.