EU GMP附录1 无菌药品生产草案20200220

译文仅供参考，草案征求意见截止日期20200529，原文参见EC官网链接

EC发布说明直链https://ec.europa.eu/health/medicinal_products/consultations/2020_sterile_medicinal_products_en下载直链https://ec.europa.eu/health/sites/health/files/files/gmp/2020_annex1ps_sterile_medicinal_products_en.pdf

或PIC/S官网下载直链https://picscheme.org/layout/document.php?id=2000
中英文PDF下载链接链接：https://pan.baidu.com/s/116tqHgnFNGH4ZlsJ9bb5Iw提取码：uyxw
Annex 1 : Manufacture of Sterile Products 附录1：无菌药品生产
1.    Scope 范围The manufacture of sterile products covers a wide range of sterile product types (active substance, sterile excipient, primary packaging material and finished dosage form), packed sizes (single unit to multiple units), processes (from highly automated systems to manual processes) and technologies (e.g. biotechnology, classical small molecule manufacturing and closed systems). This Annex provides general guidance that should be used for the manufacture of all sterile products using the principles of Quality Risk Management (QRM), to ensure that microbial, particulate and pyrogen contamination is prevented in the final product.无菌药品的生产包括多种无菌药品类型（活性物质、无菌辅料、内包材和制剂）、包装尺寸（单个包装单位至多个包装单位）、工艺（从高度自动化系统至手动工艺）和技术（例如，生物技术、传统小分子生产和密闭系统）。本附录通用指南适用于使用质量风险管理（QRM）原则的所有无菌药品生产，以确保防止产品受微生物、颗粒物和热原污染。QRM applies to this document in its entirety and will not be referred to in specific paragraphs. Where specific limits or frequencies are written, these should be considered asa minimum requirement. They are stated due to regulatory historical experience of issues that have previously been identified and have impacted the safety of patients.QRM适用于本文所有部分，因此不会在各章节中特意引用。如有章节写明了具体的限度或频次，则应作为最低要求。之所以写明是因为药监机构之前已发现过这类问题，且发现其对患者安全产生影响，有历史经验。The intent of the Annex isto provide guidance for the manufacture of sterile products. However, some ofthe principles and guidance, such as contamination control strategy, design of premises, cleanroom classification, qualification, monitoring and personnel gowning, may be used to support the manufacture of other products that are not intended to be sterile such as certain liquids, creams, ointments  and low  bioburden  biological intermediates  but  where the  control  and reduction  of microbial, particulate and pyrogen contamination is considered important. Where a manufacturer elects to apply guidance herein to non-sterile products, the manufacturer should clearly document which principles have been applied and acknowledge that compliance with those principles should be demonstrated.附录的目的是为无菌药品生产提供指南。但是有些原则和指南，如污染控制策略、设施设计、洁净间分级、确认、监测和人员更衣，亦可用于支持其它非无菌但控制和降低微生物、粒子和热原污染非常重要的药品的生产，如特定的液体、膏剂、霜剂和低生物负载的生物中间体，如果生产商决定应用本指南生产非无菌药品，则该生产商应清楚写明适用哪条原则，并要证明与这些原则的符合性。

       文章来源：蒲公英制药论坛

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