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56 September 2016 Tablets & Capsules c i o h t c a e c i o h t c a e r G ™ IQ n e al g . t t e t s t ta a e r . G G e c G e c e l l k fi l u e b h – t ™ . r. e d n i b - r- • ) P , J , BP F N - P S , U . r u . E h (P e d a r g - a m r a h s p ™ i Q I n e l a g • . t n a as e l e p t as e t n i c i d e m t • t e e w h s t i r w e d n i b - r e l l e fi h T . ms r o f fo e g osa d f d o y t e i r va d se e u o b t t n e i p i c x ce e i o h c t i l a n o i t c n u fu i t ul s m t o i e t u D t l a m so e I s e ak t m a h . e t s a e t k i l - r a g u t s d a o r r a b o d f fo t s e r b u o y y t B Barcelona, Spain 4-6 O Come BOOTH #4L75 rcelona, Spain October 2016 e and visit us at om c . Q I n e l a g . w w w · om c . Q I n e l a g @ o fo n i : s t u c a t n o e c s a e l P . ™ Q I en l a g h t wi t en m p o l e v de t c u d o r r p u o r y o e f l b a l i a v s a s i t r e p x f e m o a e r t u O turer of the original excipient. For some distributors, however, purifiying and/or additional processing—without getting permission, authorization, or agreement from the excipient manufac- turer—is part of their business model and they may not want to identify the original manufacturer. In such cases, the distributors should take full respon- sibility for following the appropriate GMPs and allow their process to be tribution. This also requires that the distributor take full responsibility for following appropriate GMP and allow customer audits. Further processing. Some distribu- tors may further process excipients— usually by purifying them at the request of the customer and with the permission of the excipient manufac- turer. In such cases, the distributor should offer to identify the manufac- audited by the FDF manufacturer. Sampling and testing. In addition to providing free samples of excipients to potential customers for use in devel- opment, some distributors provide test results for materials in order to save the FDF manufacturer time and money. Of course, all sampling and testing should follow GMP and Good Laboratory Practice. Working with a new distributor One of the best tools for vetting any excipient supplier is The IPEC Excipient Information Package (EIP), a guide that you can download free (after registering) from the IPEC- Americas bookstore at its website. The EIP provides examples of information that excipient suppliers (manufactur- ers, distributors, etc.) should collect, document, and provide to existing and prospective customers to support their excipients' use in drug products. A completed EIP should include the sup- plier's product regulatory datasheet(s), a site quality overview, and a site and supply chain security overview. Even if a supplier hasn't formally provided an EIP for its products to a distributor, the EIP provides the dis- tributor with a good framework for the type of information it might collect and share with FDF manufacturers who are considering the company as a new distributor. In addition to receiving an EIP, FDF manufacturers may want to know whether the distributor is authorized by the manufacturer to sell the prod- uct(s). If authorized, distributors will gen- erally have a written agreement with the manufacturer that spells out, among other things, their shared liabi- lity for the product. Authorized distrib- utors may sell the manufacturer's prod- uct(s) in "closed containers" (the manu- facturer's original, sealed packages accompanied by the manufacturer's Certificate of Analysis (CoA) and other relevant paperwork) or they may repackage or perform other processes on the product(s) with the manufac- turer's express, written permission. In the case of repackaging, the manufac-