近日，瑞士药监局发布了EU GMP附录1《无菌药品生产》（同时也是PIC/S和WHO GMP附录1）的解读文件，该文件侧重于新版EU、PIC/S和WHO GMP附录1的一些最重要的变化，也涵盖了长期以来反复引起问题的方面。反映了检查员对这些主题的一般意见，并在无菌药品制造商检查期间提供支持。文件包含内容如下：1 Purpose and ...
导读:新版EU GMP附录1《无菌药品生产》已发布有一年时间,并将于2023年8月25日(除8.123节外,8.123节2024年8月25日生效),它同时也是PIC/S和WHO的GMP新附录,生效日期也与欧盟相同。 新版EU GMP附录1《无菌药品生产》已发布有一年时间,并将于2023年8月25日(除8.123节外,8.123节2024年8月25日生效),它同时也是P...
[4.1] 遵循基于风险的方法,系统确认和验证应特别挑战用于做出GMP决策的系统的关键部分,确保产品质量和数据完整性的部分以及专门设计或定制的部分。 11. [4.4] It is not sufficiently clear what is implied by the sentence saying “User requirements should be traceable throughout the life-cycle”. A user r...
4.31 The microbial contamination level of the cleanrooms should be determined as part of the cleanroom qualification. The number of sampling locations should be based on a documented risk assessment and the results obtained from room classification, air visualization studies and knowledge of the proces...
近日,瑞士药监局发布了EU GMP附录1《无菌药品生产》(同时也是PIC/S和WHO GMP附录1)的解读文件,该文件侧重于新版EU、PIC/S和WHO GMP附录1的一些最重要的变化,也涵盖了长期以来反复引起问题的方面。反映了检查员对这些主题的一般意见,并在无菌药品制造商检查期间提供支持。
This solution was placed in a production room with an EU-GMP class D classification. During an audit related to the start-up, our governing body requested to see results to determine if the robotic solution could uphold the EU-GMP classification for its respective areas, and sustain the same...
13. [6] Guidelines should be included for classification of critical data and critical systems. [6] 应包括关键数据和关键系统的分类指南。 14. [7.1] Systems, networks and infrastructure should protect the integrity of GMP processes and data. Examples should be included of measures, both physical ...
(CNC) through an airlock or pass-through hatch directly into an area with two grades higher classification (grade C area), provided that suitable technical and/or procedural measures are established ensuring fulfilment of the cleanroom specifications in the respective areas. The adequacy of the ...
For Grade A the airborne particle classification is ISO 4.8 dictatedby the limit for particles ≥5.0 µm. For Grade B (at rest) the airborne particle classification isISO 5 for both considered particle sizes. . For Grade C (at rest & in operation) the airborneparticle classification is ...
中国新版GMP与EU GMP和FDA的区别