Pharmaceutical Technology - May 2019

Pharmaceutical Technology - eBook

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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2019 37 Global supply chain PharmTech: What are some of the challenges with supplying single-use systems and components globally today? Isberg (Entegris): One area of concern is avail- ability of customization. Large suppliers tend to focus on systems with larger quantity production, leaving short-run, highly custom systems to small boutique suppliers. Consolidation of the single-use suppliers has exacerbated this issue. Bulpin (MilliporeSigma): Single-use supply chains are complex and dynamic. The large number of raw materials makes forecasting demand more difficult and requires robust materials management, supplier quality management, quality control, and business continuity planning to ensure continuity of supply. Common materials (e.g., silicone) are used across many vendors, which can create single points of fail- ure within the supply chain for both the single-use supplier, as well as the end-users of their products. The key is to adopt a comprehensive, 'risk-smart' approach to supply continuity and control. It is important that suppliers proactively identify the potential risks and minimize the probability and impact of supply disruptions through effective demand planning/forecasting, capacity planning, business continuity planning, change control man- agement, disaster recovery planning, supply-chain mapping, and continuous improvement. At Milli- poreSigma, a cross-functional team of subject mat- ter experts assess risks related to demand volatility/ forecast accuracy, manufacturing capacity, process and equipment, sole/single-sourced raw materials, facilities (e.g., water, utilities, power, information technology/systems), and more. Risks above a cer- tain risk priority number are mitigated and moni- tored. Business continuity plans are revisited on a regular basis, and risk mitigation activities are updated continually. Pora (Pall): Sourcing and lead times have long been challenges for both suppliers and consumers, with some of the key pain points including lead times and an ever-changing and advancing industry. One of the most critical challenges is that bio- pharma is a high-risk industry. Although there have been a multitude of advances in the industry, the fact remains that the end products being made with SUS consumables are being used in humans and can mean life or death for a patient or a patient population. Even at the clinical trial manufactur- ing phase, a full understanding of how the process will scale is needed. Particularly in cases where high customization can be called for, the supply chain be- comes more complicated and impacts the lead time. Another challenge is just-in-time (JIT) delivery and customization. Warehousing requirements for larger spaces helps to solve storage and availability issues for off-the-shelf consumables but does not ad- dress the JIT approach or customized needs many consumers require for their process consumables. A third challenge is that as suppliers (and the indus- try) evolve, product ratings, design, or supply chain sources may change, and it is critical to keep users informed. Transparency is a necessity, yet changes can impact existing processes and lead times. As an industry, and through supplier associations like BPSA [Bio-Process Systems Alliance] and BPOG [BioPhorum Operations Group], we are working to overcome these challenges. There is a greater focus than ever on creating realistic supply-chain map- ping models that address the global nature of today's market. And a deeper importance is being placed on forecasting by end users so that the supplier and consumer can work together more effectively.

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