Tablets & Capsules


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eye on product(s). But a good distributor greatly facilitates this process for the FDF manufacturer. Good distribution practice Excipient distributors should be using excipient Good Distribution Practice (GDP). Currently, the most- used GDP standards in the USA, Canada, and Europe are IPEC Good Distribution Practices from the Inter- national Pharmaceutical Excipient Council and ExciPact's Good Distribution Practices. In addition, IPEC-Americas is developing the Good Distribution Practices Guide for NSF/IPEC/ANSI 363-2014 Excipient Good Manufacturing Practices (accredited by the American National Standards Institute in late 2014). Once completed, the practices outlined in that guide are expected to replace those found in the IPEC GDP Guide. The role of distributors Excipient distributors have many important roles in serving FDF manu- facturers. What follows is a summary of some of the benefits excipient dis- tributors offer. Purchase quantity. Most excipient manufacturers supply their products to markets that produce in much higher volume than the pharmaceutical indus- try. As a result, the minimum quantity they will sell is often much greater than what FDF manufacturers would consume over a reasonable time—it'd take them years—and/or greater than what a product's shelf-life would allow. To meet the needs of FDF manufactur- ers, distributors often purchase the minimum quantities (e.g., a pallet of 40 20-kilogram bags or 10,000 kilo- grams of liquid) from excipient manu- facturers and sell a fraction of them to different FDF manufacturers. When qualified and approved, the distributor may even repackage an excipient man- ufacturer's smallest unit (e.g., 5-gallon pail, 20-kilogram bag, etc.) into even smaller packages (e.g., 16-ounce bot- tles, 1-gallon pails, 1-kilogram bags, etc.). As a result, distributors can sup- ply FDF manufacturers with the quan- tities that meet their needs while maxi- mizing their total unit cost savings (based on inventory costs and loss of product due to shelf-life limitations). Quicker service. Distributors usu- ally stock the products they resell because, as mentioned above, they buy in greater quantities than individ- ual customers need. Keeping products in stock is especially important if the distributor resells excipients made out- side the USA or Canada. In that case, distributors plan their inventory based on the time needed for ocean-going ships (the usual mode of transporta- tion for excipients made abroad) to reach their destination and for the shipment to clear customs and receive the necessary paperwork. Thus an FDF manufacturer who buys a foreign- made excipient from a distributor can save months of lead time. In the case Tablets & Capsules September 2016 53 Linda Herzog IPEC-Americas excipients Many companies rely on distributors to supply their excipients. What's their role? In the excipient world, it's under- stood that the term "distributor" implies a business that resells excipi- ents made by a different entity (manu- facturer). There are a number of com- mercial entities that resell excipients, and in order to ask the right questions and ensure the integrity of your excip- ient supply chain, it's important to understand who does what in the realm of resellers. For this discussion, let's define an excipient "distributor" as a business that takes possession and ownership of excipients and then resells trans- ports, or exports them. This definition is important for two reasons: First, taking title to the excipients implies ownership and thus a degree of liabil- ity for those excipients. Second, tak- ing possession implies an ability to physically inspect the goods and their accompanying documentation, per- haps, for example, to check for dam- age or tampering. Entities that resell excipients with- out taking title to or possession of them (such as agents and/or traders) have little "skin in the game" and thus it's left up to the customer—who's usu- ally the manufacturer of the finished dosage form, or FDF—to determine where the excipients came from. In any case, it's ultimately the responsibil- ity of the pharmaceutical manufacturer of the FDF to verify the integrity of the supply chain of custody and to determine whether the excipients are of suitable quality for use in their drug Distributors can help manage your inventory and recommend products or grades of excipients.

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