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Better Direct Compression Less Fillers Lower Cost Higher Compaction Stronger Tablets Natrium ® Granular Sodium Bicarbonate Contact us today for samples of Natrium's granular baking soda Natrium Products, Inc. www.natrium.com Tablets & Capsules September 2016 57 turer will usually recommend packag- ing, storage, and shelf-life limits to the distributor. If unauthorized, does the distribu- tor sell the product(s) in question in the manufacturer's original, sealed packages accompanied by the manu- facturer's CoA and other relevant paperwork? If not, investigate further because the manufacturer may not be liable for the product or its quality. Sometimes distributors require a confidential disclosure agreement before revealing the name of a manu- facturer, but if a distributor refuses to reveal the name of the manufacturer and/or manufacturing location of the product(s) under any circumstances, the FDF manufacturer should consider looking elsewhere for that excipient. It's also important to understand that even if the distributor is autho- rized and has a complete, well-exe- cuted EIP for the product(s) in ques- tion, the EIP isn't a substitute for an audit of the distributor to check its compliance with excipient GDP. Use IPEC-Americas' no-cost audit guide as a resource for GDP audits. It, too, is available at the website's bookstore. In addition, ExciPact, a subsidiary of the IPEC Federation, has published a no- cost GDP standard that you can download there. Both standards are used in the USA and Canada. T&C Linda Herzog is the technical and member- ship operations professional at IPEC-Amer- icas, 3138 North 10th Street, Suite 500, Arlington, VA 22201. Tel. 517 814 3450. Website: www.ipecamericas.org. Tablets & Capsules is a member of IPEC-Americas. A version of this article appeared in "Solid Dose Digest," a bi-monthly e-newsletter for T&C's print and digital subscribers. If you haven't seen the newsletter, contact Kyle Myers to begin receiving it: kmyers@ cscpub.com.