會議介紹 Conference Introduction：
塑料材質(zhì)的生產(chǎn)系統(tǒng)正在越來越多地被應(yīng)用于藥品生產(chǎn)，尤其在生物制藥的生產(chǎn)中特別突出。盡管其有眾多優(yōu)點，但同時這些塑料組件的使用也引起了對其化學(xué)成分的顧慮，即那些可能會發(fā)生遷移進入最終產(chǎn)品并影響藥物的質(zhì)量或安全性的化學(xué)成分。如何評估這類生產(chǎn)系統(tǒng)及其潛在影響，將是對供應(yīng)商和終端用戶的挑戰(zhàn)。美國藥典委員會 (USP) 作為全球領(lǐng)先的藥物質(zhì)量標準制定機構(gòu)，其包材和流通專業(yè)委員會正在致力于開發(fā)具有科學(xué)性及實用性的方法用于生產(chǎn)用塑料系統(tǒng)的評估與驗證。本次為期一天半的研討會將邀請海內(nèi)外標準設(shè)定機構(gòu)、法規(guī)監(jiān)管、“一次性使用系統(tǒng)（SUS）”制造企業(yè)、制藥領(lǐng)域等專家共聚一堂，分享有關(guān)SUS的觀點、見解和實踐經(jīng)驗；介紹USP致力于開發(fā)生產(chǎn)用塑料系統(tǒng)標準的背景及基本考量，并籍此為基礎(chǔ)建立的通則標準<661.1>塑料材質(zhì)組件、<661.2>藥用塑料包裝系統(tǒng)、<1663> 藥物包裝/給藥系統(tǒng)的可提取物評估、<1664>藥物包裝/給藥系統(tǒng)的浸出物評估，以及提議的新通則<665>化學(xué)制藥和生物制藥生產(chǎn)中使用的聚合物組件和系統(tǒng)和<1665> 藥物生產(chǎn)中使用的聚合物組件和系統(tǒng)；并對風(fēng)險矩陣-決定生產(chǎn)用塑料材質(zhì)和組件測試的決策樹、生產(chǎn)用塑料材質(zhì)和組件的化學(xué)表征及毒理和生物活性評估、工業(yè)界正面臨的生產(chǎn)中“一次性使用系統(tǒng)”完整性的挑戰(zhàn)等議題進行探討。同時，通過本次研討會，進一步收集關(guān)于SUS的觀點和評議，并圍繞確證生產(chǎn)用塑料系統(tǒng)的多種提取方案，以及生產(chǎn)系統(tǒng)基于風(fēng)險的測試等熱點議題展開討論。
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.
參會對象 Participants：
制藥、醫(yī)療器械和生物工程行業(yè)從事工藝開發(fā)相關(guān)研發(fā)人員；國際注冊和法規(guī)事務(wù)人員；法規(guī)監(jiān)管人士；包材生產(chǎn)、質(zhì)量保證和質(zhì)量控制人員；方法驗證工程師；包材工程師；SUS質(zhì)量和技術(shù)研究的學(xué)術(shù)機構(gòu)/科研單位人員；以及其他對研討會主題感興趣的人士。
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.