建立有效的校准程序：哪些仪器需要校准？哪些仪器不需要校准？

来源：Pharmaceutical Online

Calibration Determination

校准决定

An effective calibration program must firstidentify which items must be calibrated. The following items must becalibrated: items used to make a release (quality) decision, items used to setcritical process settings, items used to monitor critical process(environmental) conditions, and items used to make measurements supportingequipment product, process, design verification/validation/qualificationactivities.

一个有效的校准程序必须首先确定哪些测量项目必须校准。以下测量项目必须进行校准：用于做出放行(质量)决定的测量项目，用于设置关键工艺参数的项目，用于监测关键工艺(环境)条件的项目，以及用于测量支持设备、工艺、设计验证/验证/确认活动的仪器。

Items used to make a release (quality)decision or used to approve materials, components, subassemblies, assemblies,and finished goods at incoming, in-process, or final inspection must becalibrated to ensure compliance with predetermined specifications.

用于做出放行(质量)决定或用于在入库、中控或最终检验中进行物料、组分、组件、和成品批准的测量项目必须进行校准，以确保符合预定的标准。

Items used to set critical process settingsmust be calibrated. Items that set critical process settings, such astemperature, pressure, time, etc., are examples of items typically used tocontrol a process to ensure process outputs meet predetermined specifications.

用于设置关键工艺参数的项目必须进行校准。设置关键工艺参数的项目，如温度、压力、时间等，是典型的用于控制工艺的项目，以确保工艺输出满足预定的标准。

Items used to monitor critical process(environmental) conditions must be calibrated. Items used to monitor criticalprocess conditions such as pressure differential, temperature, and humidity areexamples of items typically used to monitor critical process conditions toensure process outputs meet predetermined specifications.

用于监测关键工艺(环境)条件的项目必须进行校准。用于监测关键工艺条件(如压差、温度和湿度)的项目是常见的关键工艺条件监测项目以确保工艺输出符合预定标准。

Items used to make measurements supportequipment product, process, design verification/validation/qualificationactivities include those that are used to approve materials, components,subassemblies, assemblies, and finished goods, set critical process settings,and monitor critical process (environmental) conditions.

用于测量支持设备、工艺、设计确认/验证/确认活动的项目，包括用于物料、组分、组件、和成品批准、设置关键工艺参数和监测关键工艺(环境)条件的项目。

Reference Only Calibration Not Required

用于参考目的不需要校准

Instruments that are not used to get exactmeasurements but are used only to obtain status information do not requirecalibration. Table 2 provides some examples of when calibration may and may notbe required.

不用于获得精确测量而仅用于获取状态信息的仪器不需要校准。表2提供了一些可能需要和可能不需要校准的示例。

Calibration Not Required 不需要校准	Calibration  Required 需要校准
Calipers  that are verified against a traceable standard before each use 每次使用前根据可追溯标准进行确认的卡尺	Calipers  that are not verified against a traceable standard before each use 每次使用前没有根据可追溯标准进行确认的卡尺
Voltmeter  used for basic maintenance activities 用于基本维护活动的电压表	Voltmeter  used to take measurements used for qualification, validation, verification,  and inspection activities 用于确认、验证、确证和检验活动的电压表
Weight  scale used for the purposes of determining postage (not a quality  measurement) 用以确定邮费的重量秤(非质量量度)	Weight  scale used to determine pass/fail quality criteria 用于确定符合/不符合质量标准的重量秤
Pressure  gauge used to show the amount of nitrogen gas in a cylinder 用于显示钢瓶中氮气数量的压力表	Pressure  gauge where a process requires a specific pressure for proper operation 一种工艺需要特定压力才能正常操作的压力表
Tape  measure used to measure the length of pipe for a water system 用于测量供水系统中管道长度的卷尺	Tape  measure used to measure a fabricated part to determine pass/fail quality  criteria 用于测量制造部件，以确定符合或不符合质量标准的卷尺

Table2: Calibration not required/calibration required examples.

表2:不需要校准/需要校准示例。

Another simple test that I like to use todetermine if calibration is required is to apply this simple test: If the itemwas covered (not visible), can the process be set up, monitored, and operated correctly?If the answer is no to any of these questions, the item must be calibrated;otherwise, calibration is not required.

另一个我喜欢用来确定是否需要校准的简单测试：如果没有该项目，过程是否可以被正确设置、监测和操作？如果这些问题的答案都是否定的，就必须对仪器进行校准；否则，不需要校准。