想找一段文字关于实验室设备分级的？

尚坡

记得在哪里看见过，实验室的设备要分级 根据级别确定是否要做验证、还是简单的做个校准就可以，中国药典上？美国药典上？ GMP指南上？还是ISO什么上 找不到了求告知

匿名

USP中有。以下引用版本不祥。

INSTRUMENT CATEGORIES仪器种类
Modern laboratories typically include a suite of instruments and equipment varying from simple nitrogen evaporators to complex automated instruments. Therefore, applying a single set of principles to qualifying such dissimilar instruments would be scientifically inappropriate. Users are most capable of establishing the level of qualification needed for an instrument. On the basis of the level needed, it is convenient to categorize instruments into three groups: A, B, and C, as defined below. Examples of instruments in each group are provided. Note that the list of instruments provided here is for illustration only and is not meant to be exhaustive. It does not provide the exact category for an instrument at a user site. That category should be determined by users for their specific instruments or applications.
现代实验室通常包括一套仪器和设备，差异从氮吹仪到复杂的自动仪器。因此，应用单一的一套原则来确认这样不同的仪器将是不科学的。使用者最有能力确立某个仪器所需要的确认程度。基于所需的程度，可以方便地将仪器分为三类：A、B、C，具体定义如下。每类仪器均提供了样板。注意，在此提供的仪器清单仅仅用于举例说明，并不意味着全部仪器。其并未提供在用户场所的某个仪器的准确类别。该类别应该由用户根据他们具体的仪器或用途来确定。
The exact grouping of an instrument must be determined by users for their specific requirements. Depending on individual user requirements, the same instrument may appropriately fall into one group for one user and another group for another user. Therefore, a careful selection of groups by users is highly encouraged.
某个仪器的准确分组必须通过使用者对其的具体要求来确定。取决于具体的用户需求，同样的仪器可以适当地在一个用户处归为一类，而在另一个用户处归为另外一类。因此，强烈鼓励由用户对分类进行仔细选择。
Group A A类
Group A includes standard equipment with no measurement capability or usual requirement for calibration, where the manufacturer’s specification of basic functionality is accepted as user requirements. Conformance of Group A equipment with user requirements may be verified and documented through visual observation of its operation. Examples of equipment in this group are nitrogen evaporators, magnetic stirrers, vortex mixers, and centrifuges.
A类包括没有测量能力或通常的校准要求的标准设备，其中制造商对基本功能的标准被接受为用户需求。A类设备与用户需求的符合性可以通过肉眼观察其操作来确认，并以文件记录。此类设备的样板是氮吹仪、磁力搅拌器、漩涡混合器、和离心机。
Group B B类
Group B includes standard equipment and instruments providing measured values as well as equipment controlling physical parameters (such as temperature, pressure, or flow) that need calibration, where the user requirements are typically the same as the manufacturer’s specification of functionality and operational limits. Conformance of Group B instruments or equipment to user requirements is determined according to the standard operating procedures for the instrument or equipment, and documented during IQ and OQ. Examples of instruments in this group are balances, melting point apparatus, light microscopes, pH meters, variable pipets, refractometers, thermometers, titrators, and viscosimeters. Examples of equipment in this group are muffle furnaces, ovens, refrigerator-freezers, water baths, pumps, and dilutors.
B类包括提供测量所得数值的标准设备和仪器，以及控制需要校准的物理参数（例如温度、压力、或流动）的设备，其中用户需求通常与制造商的功能标准和操作限度相同。B类仪器或设备对用户需求的符合性是按照该仪器或设备的标准操作程序来测定的，并在IQ和OQ中以文件记录。此类仪器的样板是天平、熔点仪、光学显微镜、酸度计、可变量移液器、折光仪、温度计、滴定仪、黏度计。此类设备的样板是马弗炉、烘箱、冰箱-冰柜、水浴锅、泵、稀释仪。
Group C C类
Group C includes instruments and computerized analytical systems, where user requirements for functionality, operational, and performance limits are specific for the analytical application. Conformance of Group C instruments to user requirements is determined by specific function tests and performance tests. Installing these instruments can be a complicated undertaking and may require the assistance of specialists. A full qualification process, as outlined in this document, should apply to
these instruments. Examples of instruments in this group include the following:
C类包括仪器和计算机化系统，其中对功能、操作、性能限度的用户需求针对特定的分析用途。C类仪器对用户需求的符合性通过具体的功能测试和性能测试来测定。安装这些仪器可以是一项负责的任务，并可能要求专家的协助。应该将在此文件中所描述的完全确认程序应用于这些仪器。此类仪器的样本包括下面这些：
􀁺 atomic absorption spectrometers原子吸收光谱仪
􀁺 differential scanning calorimeters差示扫描量热仪
􀁺 dissolution apparatus溶出度仪
􀁺 electron microscopes电子显微镜
􀁺 flame absorption spectrometers火焰吸收光谱仪
􀁺 high-pressure liquid chromatographs高压液相色谱仪
􀁺 mass spectrometers质谱仪
􀁺 microplate readers酶标仪
􀁺 thermal gravimetric analyzers热重分析仪
􀁺 X-ray fluorescence spectrometers X射线荧光光谱仪
􀁺 X-ray powder diffractometers X射线粉末衍射仪
􀁺 densitometers密度计
􀁺 diode-array detectors二极管阵列检测器
􀁺 elemental analyzers元素分析仪
􀁺 gas chromatographs气相色谱仪
􀁺 IR spectrometers红外光谱仪
􀁺 near-IR spectrometers近红外光谱仪
􀁺 Raman spectrometers拉曼光谱仪
􀁺 UV/Vis spectrometers紫外/可见光光谱仪
􀁺 inductively coupled plasma-emission spectrometers电感耦合等离子发射光谱仪

独钓寒江雪丶

培训上看到的吗？

静水蓝心

谢谢楼上分享

尚坡

匿名 发表于 2016-11-17 12:56
USP中有。以下引用版本不祥。

INSTRUMENT CATEGORIES仪器种类

对就是这个

芹菜卷

药品GMP指南分册《质量控制实验室与物料系统》的第101页有相关描述，不知道是不是你曾经看到过的。

PharmaGMP

usp 1058

PharmaGMP

http://mp.weixin.qq.com/s/4SiFIWz9kkVw--10b_MaJg

松风晚窗里

谢谢分享

疯子小小

GMP指南上也有的