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12月20日,欧盟委员会发布了原料药和制剂EU GMP附录1“无菌药品生产”修订草案征求公众意见。该指南最早于1971年发布,上一次修订是在2008年。
总体来说,该文件内容增加了很多。2008年修订版本中,该文件仅16页,新的文件则增修至50页。这是为了让附录有一个清晰的结构,按其内容依序排列。从下表内容可见一斑:
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General Overview
概览
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Additional areas (other than sterile medicinal products) where the general principles of the annex can be applied.
(除了无菌药品以外)其它适用该附录的领域的通则
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General principles as applied to the manufacture of medicinal products.
适用于药品生产的通则
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Highlights the specific requirements of the PQS when applied to sterile medicinal products.
强调了无菌药品中PQS的特定要求
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Guidance on the requirements for specific training,knowledge and skills. Also gives guidance to the qualification of personnel.
特定培训知识和技能要求指南,还有人员资质确认指南
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General guidance regarding the specific needs for premises design and also guidance on the qualification of premises including the use of barrier technology.
关于设施设计的特定需求通用指南,以及设施确认包括隔离技术应用的指南
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General guidance on the design and operation of equipment.
设备设计和运行方面的通用指南
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Guidance with regards to the special requirements of utilities such as water, air and vacuum.
关于公用系统,如水、空气和真空方面的特殊需求指南
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Discusses the approaches to be taken with regards to aseptic and terminal sterilisation processes. Also discusses different technologies such as lyophilisation and Blow Fill Seal (BFS) where specific requirements may be required. Discusses approaches to sterilization of products, equipment and packaging components. 讨论了无菌和终端灭菌工艺方面使用的方法,还讨论了不同技术,如冻干和吹灌封(BFS), 可能需要的特殊要求。讨论了药品、设备和包装部件的灭菌方法。 |
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This section differs from guidance given in section 5 in that the guidance here applies to ongoing routine monitoring with regards to the setting of alert limits and reviewing trend data. The section also gives guidance on the requirements of Aseptic Process Simulation.
本部分与第5部分的指南有所不同,本部分适用于在持续的日常监测,用于警戒限设定以及趋势数据审核。本部分还提供了关于无菌工艺模拟要求方面的指南。
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Gives guidance on some of the specific Quality Control requirements relating to sterile medicinal products.
给出了与无菌药品有关的一些特定质量控制要求指南
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Explanation of specific terminology.
特定术语的解释
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文件中内容排列顺序进行了重大修改。关于洁净室的分级(按新的ISO 14644标准),及其确认相关的信息放在设施的通用部分之后。
≥ 5 μm粒径的悬浮粒子已从ISO14644的洁净室确认中删除了,但仍保留在非活性粒子的监测推荐限度中。
is considered to be a sterilizing unit and all sterilizing-grade filters within it should satisfactorily pass integrity testing both before use,
in case of damage during processing, and after use.
文章来源:GMP办公室
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