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How Rx-360 and Fagron are working together to assure patient safety in compounded medicines
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Pieter Reinouts van Haga, heading the International Quality Management Department and Jonathan Fawdry, General Manager of Fagron UK look at why Rx-360 makes sense to Fagron, our customers and suppliers.
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About Fagron: Fagron is the only multinational one-stop-shop for products and services for pharmaceutical compounding in Europe and USA. Fagron not only offers high-quality raw materials and semi-manufactured products for compounders; it also offers supply solutions for manufacturers of APIs for smaller scale customers. Fagron operates in over 20 countries worldwide, with over 100,000 customers that include pharmacies, hospitals, pharmaceutical, veterinary, cosmetic and other manufacturers.
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About compounded medicines: Compounded or extemporaneous preparations provide tailor-made solutions for patients for whom medication is not available in standard form. Patient personalised care includes producing appropriate doses for children, oral suspensions for elderly patients who have difficulty swallowing and for patients allergic to specific excipients.
Ensuring Product Quality through the supply chain: Fagron's Quality Assurance System includes global sourcing, supplier qualification, full analysis and release, conditioning (or packing down) under GMP and logistics under GDP. We service an important niche in the pharmaceutical industry and we aim to ensure that our customers and their patients have the best possible materials for their needs.
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With several hundred suppliers for our more than 1500 core products, supplier and product qualification is a key issue. Our customers who make individual medicines and buy 200g need access to the same documentation and audits as those who buy 200MT.
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API manufacturers and smaller scale customers look to us to act as a conduit for the essential certification and small packs in one direction and valuable customer information in the other. We provide these services and deliver cost effectively for all parties, and Rx-360 is helping us continue to do this.
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Fagron’s strength in the supply chain: Fagron also supplies the smaller customers of some API producers, where our scale of operation is seen as more appropriate to the needs of both manufacturer and customer.
Operating at a smaller scale does not mean smaller problems. If anything, the complexity of the supply chain is increased, and Fagron is leading the way in the development of multi-national partnership solutions for the supply of small packs of raw materials for human use.
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Our conditioning sites hold relevant (c)GMP licences and the combination of robust systems, state of the art cleanrooms and trained and experienced staff means that we are trusted by pharmacies, hospitals, multinational pharmaceutical firms not only in Europe and America but across the Globe: http://www.fagron.com/categories/1/pages/4
Fagron supports Rx-360’s efforts to share audits, and got involved early on by sharing audits with the consortium. Fagron believes the consortium will become a key partner as the audit program is rolled out. As Rx-360 says: ‘patient safety is a not a competitive advantage’ and we believe that sharing these audits is an important step toward making us all better able to ensure the products we deliver to patients are safe.
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