会议介绍 Conference Introduction：
塑料材质的生产系统正在越来越多地被应用于药品生产，尤其在生物制药的生产中特别突出。尽管其有众多优点，但同时这些塑料组件的使用也引起了对其化学成分的顾虑，即那些可能会发生迁移进入最终产品并影响药物的质量或安全性的化学成分。如何评估这类生产系统及其潜在影响，将是对供应商和终端用户的挑战。美国药典委员会 (USP) 作为全球领先的药物质量标准制定机构，其包材和流通专业委员会正在致力于开发具有科学性及实用性的方法用于生产用塑料系统的评估与验证。本次为期一天半的研讨会将邀请海内外标准设定机构、法规监管、“一次性使用系统（SUS）”制造企业、制药领域等专家共聚一堂，分享有关SUS的观点、见解和实践经验；介绍USP致力于开发生产用塑料系统标准的背景及基本考量，并籍此为基础建立的通则标准<661.1>塑料材质组件、<661.2>药用塑料包装系统、<1663> 药物包装/给药系统的可提取物评估、<1664>药物包装/给药系统的浸出物评估，以及提议的新通则<665>化学制药和生物制药生产中使用的聚合物组件和系统和<1665> 药物生产中使用的聚合物组件和系统；并对风险矩阵-决定生产用塑料材质和组件测试的决策树、生产用塑料材质和组件的化学表征及毒理和生物活性评估、工业界正面临的生产中“一次性使用系统”完整性的挑战等议题进行探讨。同时，通过本次研讨会，进一步收集关于SUS的观点和评议，并围绕确证生产用塑料系统的多种提取方案，以及生产系统基于风险的测试等热点议题展开讨论。
Plastic manufacturing systems have been increasingly used in manufacturing processes, particularly biological manufacturing processes. Despite their multitude of advantages, these plastic assemblies also draw concerns about chemical compounds that may migrate to finished products and impact product quality or safety. Evaluation of such manufacturing systems and their potential impact remains a challenge for suppliers and end users. USP, as part of the global leading standard-setting organization for medicines, the Packaging and Distribution Expert Committee is developing a practical and science-based approach for the qualification of plastic manufacturing systems. The intention of the workshop will be to engage stakeholders, both domestic and international from standard-setting organizations, regulatory agencies, Single Use Systems (SUS) suppliers and end-users. The objective will be to share and exchange current information, perspectives and practices on SUS and to give background on USP’s effort to develop standard for plastic manufacturing systems, which builds off existing plastic standards <661.1> Plastic Materials of Construction; <661.2> Plastic Packaging Systems for Pharmaceutical Use; <1663> Assessment of Extractables Associated with Pharmaceutical Packaging / Delivery Systems and <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging Delivery Systems, and new proposed standards <665> Polymeric Components and Systems Used in the Manufacturing of Pharmaceuticals and Biopharmaceuticals Drug Products, <1665> Polymeric Components and Systems Used to Manufacture of Pharmaceuticals. The workshop will also gather further perspective on the various extraction protocols used to qualify plastic manufacturing systems and ideas around risk-based testing of manufacturing systems.
参会对象 Participants：
制药、医疗器械和生物工程行业从事工艺开发相关研发人员；国际注册和法规事务人员；法规监管人士；包材生产、质量保证和质量控制人员；方法验证工程师；包材工程师；SUS质量和技术研究的学术机构/科研单位人员；以及其他对研讨会主题感兴趣的人士。
Personnel from the following functional areas of Pharmaceutical, Device and Biotechnology companies will benefit from this workshop: Process Development, Analytical Development, Research and Development, Regulatory Compliance, Manufacturing/Operation Packaging, Quality Assurance, Quality Control, Quality Audits, Validation Engineer, Packaging Engineer, Academic Research involving SUS quality and analytical technologies, and others interested in the topics of this workshop.