苏州的一天（2024.11.23）-学习札记⑤ 号外

歪说歪有李

看看明年，关于天平会有多少故事，至少9032 分析用电子天平称量指导原则 上药典是板上钉钉的事情了，已经有号了。但要注意Msnw和Mmin的含义，这个和UPS 1251有区别。
链接：药典委员会  关于9032分析用电子天平称量指导原则标准草案的公示

对于USP，看看90天的公众评论期过后，会不会走向快速通道。
链接：（USP可以免费注册账号，免费看PF的，当前是PF 50（5））
1. USP-NF 〈41〉 Balances
2. USP-NF 〈1251〉 Weighing on an Analytical Balance

美国药典和中国药典，齐头并进了； PH.Eur. 这次稍慢一步哟，加油！

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〈41〉 Balances.  天平  （注：通则 21~50 属于用于测试-test和分析-assay用仪器-apparatus）
This proposal is based on the version of the chapter official as of August 1, 2019. The previous proposal, published in PF 49(5) [Sep.–Oct. 2023], has been canceled and is being replaced with this new proposal. On the basis of comments received from stakeholders and to align with Weighing on an Analytical Balance 〈1251〉 as well as the European Pharmacopoeia chapter “Balances for Analytical Purposes”, it is proposed to make the following changes:
本提案基于截至2019年8月1日的通则官方版本。先前的提案发表在PF 49(5)[9-10-2023]，已经被取消，取而代之的是这个新提案。根据从利益相关者那里收到的意见，并与分析天平称重< 1251 >以及欧洲药典章节“用于分析目的的天平”保持一致，建议进行以下更改：
1. Introduce the relationship between calibration and performance checks within the life cycle approach to ensure fitness for purpose.
    介绍生命周期方法中的校准与性能检查的关系，以确保适合预期目的。
2. Include the concept of a risk-based approach with respect to the frequency of calibration and performance checks.
    包括基于风险的方法的校准和性能检查频率的概念。
3. Add a new section on Calibration, clarifying its purpose and including considerations for uncertainty and frequency.
    增加一个新的“校准”章节，澄清其目的，包括不确定度和频率的考量。
4. Introduce clarifications of compliance with respect to the Repeatability test.
    对重复性测试的符合性进行说明。
5. Align the term minimum weight with that in &#9001;1251&#9002; and in the European Pharmacopoeia, with regard to standard deviation. Include calculation examples.
   基于1251和欧洲药典，拉齐最小称量值和标准偏差，包括计算实例。
6. Introduce text that differentiates the minimum weight from the smallest net weight.
   引入新规定以区分 最小称量值 Mmin和最小净重  Msnw。
7. Clarify criteria to ensure compliance with the required accuracy during performance test checks and calibration, including consideration of the uncertainty of the test weights.
    澄清标准，以确保在性能测试检查和校准期间符合所需的准确性，包括考虑测试砝码的不确定度。
8. Incorporate additional applicable references into the text.
    将其他适用的引用合并到本官方文本
&#8195;Additionally, minor editorial changes have been made to update the chapter to current USP style.
此外，还进行了细微的编辑更改，以将通则更新为当前的 USP 风格。
&#8195;(GCM: Y. Liu)
&#8195;Case ID—SUB-968
&#8195;Current DocID: GUID-0778059F-4B53-414F-B496-2195C1D8C7FB_4_en-US
&#8195;DOI: https://doi.org/10.31003/USPNF_M98780_04_01



&#9001;1251&#9002; Weighing on an Analytical Balance.   以分析天平称量


This proposal is based on the version of the chapter official as of May 1, 2018. The previous proposal, published in PF 49(5) [Sep.–Oct. 2023], has been canceled and is being replaced with this new proposal. On the basis of comments received from stakeholders and to align with Balances [color=blue !important]&#9001;41&#9002; as well as the European Pharmacopoeia chapter “Balances”, it is proposed to make the following changes:
该提案基于 自 2018 年 5 月 1 日起的指导原则的官方版本。上一个提案已发布在 PF 49（5） [2023 年 9 月至 10 月] 中，已被取消，取而代之的是 这个新提案。根据从利益相关者收到的意见，并与通则 41 天平 以及欧洲药典 通则 “天平”（2.1.7，10.7版 2022年）保持一致，建议进行以下更改：
1. In the Introduction, clarify the group of instruments in which balances are included as per Analytical Instrument Qualification &#9001;1058&#9002; and its relationship with the analytical target profile described in Analytical Procedure Life Cycle &#9001;1220&#9002;.
    在简介中，阐明根据1058分析仪器确认 天平所在的仪器分组以及它与 1220 分析程序生命周期 中描述的分析目标轮廓的关系。
2. Add a new section, Principle, defining weight and units.
    添加新章节“原则”，定义重量和单位。
3. In Performance Qualification, the risk of the weighing application is explained with regard to the user’s quality management system in order to define the frequency and the type of performance qualification activities.
    在性能确认章节中，阐明应在用户的质量体系中分析称重实践的风险，以便确定执行确认活动的频率和类型。
4. Discuss the frequency of each of the individual tests included, as well as the relationship between calibration and verification.
    讨论涉及的每项测试的频率，以及校准和核查之间的关系。
5. Delete the section Balance Checks and integrate it into Performance Qualification.
    删除了天平检查并将其继成道性能确认中。
6. Simplify the definition of minimum weight and add clarifications about the tare vessel as well as examples to address frequently asked questions.
    简化最称量小值的定义 并添加有关去皮容器的说明以及示例以解决常见问题。
7. Introduce a safety factor that addresses critical performance changes of the balance during routine usage.
    引入安全系数，解决天平在日常使用过程中的关键性能变化。
8. Add a Glossary to clarify the use of specific terms.
    添加“术语表”，以阐明特定术语的用法。
9. Add Additional Information to ensure alignment of concepts and terminology.
    添加附加信息以确保概念和术语（计量领域）的一致。
&#8195;Additionally, minor editorial changes have been made to update the chapter to current USP style.
    此外，还进行了细微的编辑更改，以将指导原则更新为当前的 USP 风格。


&#8195;(GCM: Y. Liu)
&#8195;Case ID—SUB-970
&#8195;Current DocID: GUID-64BFE248-B65C-4D04-9DDE-EBF471C3BF3B_3_en-US
&#8195;DOI: https://doi.org/10.31003/USPNF_M99963_03_01



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别急，此为其一，为了苏州的一天（2024.11.23）。

当然：
每家限定1人，QC优先，设备其次，Q再次之。
联系：+微：  waishuowaiyouli
       非工作时间，如早9点前，晚5点半之后


苏州的一天（2024.11.23）-学习札记④
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苏州的一天（2024.11.23）-学习札记①

胜利者

天天在苏州

大海

好好学习天天向上

九九swx

你都会穿越了？

柠檬水好酸

穿越了？？？？看了好几遍日期

歪说歪有李

胜利者 发表于 2024-11-15 07:27
天天在苏州

23号有空不？来啊，给你留一本。