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Page 12 of 26 June 2019 BioPharm International eBook 13 Single-Use Systems Supply Chain i mpac t a na lysis to eva lu ate potential scenarios associated with business continuity and disaster recovery to be ready to respond if a serious event has the potential to interrupt opera- tions. Preventive measures and/ or recovery objectives can then be identified for all scenarios with both a high impact and/or high occurrence rating. SUPPLY-CHAIN EXPERTISE Biopharma manufacturers should conduct an ongoing evaluation of a single-use supplier's supply- c h a i n o p e r at io n a l e xc e l l e nc e capabilities. Understanding and aligning these capabilities with t he ma nu fac t u rer 's ow n qu a l- ity practices is important as bio- pharma manufacturers redesign their facilities around SUS. Collaborative planning, forecast- ing, and replenishment (CPFR) Biopha r ma ma nu fac t u rers w ill need to have suppliers that will work with them in collaborative planning, forecasting, and replen- ishment to protect their ability to effectively support manufacturing planning and ensure that orders are delivered on time. A four-step CPFR program would include the following: 1. U n d e r s t a n d i n g c u s t o m e r requirements, such as important p r o d u c t /o r d e r at t r i b ute s o f dating, documentation, order f r e que nc y, lot cont rol, a nd s t o r a g e m a t e r i a l h a n d l i n g requirements 2. E f f e c t i v e l y t r a n s f e r r i n g d o c u m e n t e d r e q u i r e m e n t s t o i n t e r n a l s y s t e m s t o "operat iona li ze" items, such as customer-care instructions, wa rehouse inst r uc t ions, a nd s e t u p o f c u s t o m e r- s p e c i f i c inventory reserves 3. Regularly engaging in customer- planning meetings to obtain updated forecasts 4. Engaging with customers and suppliers to manage changes in key factors, such as required components and lead times. Other procurement and supply- management programs a supplier might offer would include onsite services and technology to help customers streamline procurement, optimize inventor y levels, and spend less time managing supplies. They also include custom kitting solutions and ancillary supplies for production. Global logistics One of the more challenging issues facing the single-use industry is lead t imes for f in ished goods. Stock ing finished goods is one strategy to mitigate this challenge, but this strategy has inherent risks related to proper warehousing and storage space for large volumes of single-use products. As a result, biopharmaceutical manufact urers must seek alter- nate solutions for local storage and quick delivery. Third-party ware- houses should be GMP-approved. Manufacturers with multiple opera- tions around the world can ensure their single-use production opera- tions sustain targeted yields and efficiencies by working with single- use suppliers who have channel and supply-chain operational excellence capabilities designed to provide: • Single-use expertise employing a col lab orat ive approac h i n designing solutions • Access to an open-architecture p r o d u c t p o r t f o l i o w i t h c o m p o n e n t s s o u r c e d f r o m multiple suppliers • Services designed to keep single- use production running through u n ique capabi l it ies, suc h as regulatory/quality compliance, expedited design and delivery of draw ings, and committed delivery dates. AVOIDING SUPPLY-CHAIN DISRUPTION Much is at stake in biopharma- ceutical production. Quality SUS and technologies can help bio - pha r ma ma nu fac t u re r s re duce c o nt a m i n a t i o n r i s k , i m p r o v e r e s o u r c e e f f ic ie nc y, a nd u lt i - m at e l y l e a d t o b r e a k t h r o u g h solutions for many of the world's most cha l leng i ng d iseases a nd chronic conditions. Having dual suppliers for all critical compo- nents and materials isn't enough to fully mitigate risk in a single- use supply cha i n. Redu nda nc y must be bu ilt into t he supply- c h a i n p r o c e s s to avo id b e i n g dependent upon a supplier whose ow n sou rces of components or materials could be threatened. BP One of the more challenging issues facing the single-use industry is lead times for finished goods. As SUS have increasingly been implemented in GMP drug production, supply-chain assurance for SUS materials, components, and assemblies has become even more important.

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