Issue link: https://www.e-digitaleditions.com/i/377863
42 September 2014 Tablets & Capsules day. Furthermore, certification audi- tors are trained by subject-matter experts well versed in IPEC-Americas' expectations for conformance to excipient GMPs. In addition, the auditor or audit team must present and defend its report before a certifi- cation board that comprises industry executives with experience in the quality units of either pharmaceutical or excipient manufacturers. It is this four-member board that decides whether the site is in substantial con- formance to excipient GMPs. To main tain certification, the excipient site must also undergo annual audits and biannual recertification. Rx-360's audit reports, considered valid for 24 months, are also superior to 1-day visits and should be studied. Combine what you learn from them with your own audit when assessing sites that produce excipients that pose a potential risk to patient safety. Does the supplier also provide excipients, albeit in other grades, to non-pharmaceutical industries? The pharmaceutical industry is usually not the largest buyer of an excipient. For example, only 0.02 percent of the cellulose produced annually is used in pharmaceutical products. The pharmaceutical industry needs to work closely with its excipient manu- facturers to ensure they are manufac- turing ingredients with the appropri- ate GMPs in mind. Does the supplier understand the new regulatory environment? Talk with all your suppliers about the new rules and make sure they know what is required. We've found that even some manufacturers of finished prod- ucts aren't familiar with all the requirements of FDASIA and the EU's Falsified Medicines Directive as they relate to excipients. It's a safe bet that requirements are also unclear to many of the world's ingredient suppliers. The on-site audit After you've done your prep work, use a detailed auditing checklist to make your on-site visit as efficient as possible. In the most general terms, regulatory bodies in the USA and Europe require that excipients: NATRIUM For technical data and sample requests In the U.S./Canada: Nisso America Inc. A wholly-owned subsidiary of Nippon Soda Co., Ltd. Tokyo, Japan 88 Pine St 14th Fl · New York, NY 10005 · (T) 212-490-0350 · info@nissoamerica.com www.nissoexcipients.com NISSO HPC SSL SL L əÞǣOŸǣÞǼɴŎƻ˒ǣ˔ˡ˟̿Nˀˡ̇LJ 2.0 – 2.9 3.0 – 5.9 6.0 – 10.0 Molecular Weight/GPC method ~ 40,000 ~ ~ 100,000 ~ ~ 140,000 ~ Availability Regular Powder (40 mesh) Fine Powder (100 mesh) Super Fine Powder (330 mesh) Special low viscosity grades available in a range of particle sizes: Hydroxypropyl Cellulose • USP/NF, EP, JP Better Direct Compression Less Fillers Lower Cost Higher Compaction Stronger Tablets Natrium Products, Inc. 800-962-4203 www.natrium.com Contact us today for samples of Natrium's granular baking soda Natrium ® Granular Sodium Bicarbonate