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GMP車(chē)間/設(shè)備上的顯示時(shí)間,誤差標(biāo)準(zhǔn)是多少?

嘉峪檢測(cè)網(wǎng)        2025-04-28 12:46

有公司規(guī)定:

 

1. 生產(chǎn)車(chē)間用于記時(shí)的時(shí)鐘在初次使用之前應(yīng)由計(jì)量室依據(jù)廣播電臺(tái)的整點(diǎn)報(bào)時(shí)信息校對(duì)并調(diào)準(zhǔn),然后貼上校驗(yàn)標(biāo)簽。

2. 時(shí)鐘應(yīng)懸掛在車(chē)間操作人員易于讀數(shù)的地方,并且罩上玻璃罩。

3. 生產(chǎn)車(chē)間由車(chē)間計(jì)量員每周對(duì)時(shí)鐘的準(zhǔn)確性校對(duì)兩次,兩次較對(duì)應(yīng)在同一天的上午和下午各一次。

4. 當(dāng)需要對(duì)時(shí)鐘校對(duì)時(shí),車(chē)間計(jì)量員將時(shí)鐘拿到計(jì)量室,打開(kāi)收音機(jī),聽(tīng)廣播電臺(tái)的整點(diǎn)報(bào)時(shí)并校對(duì)時(shí)鐘,同時(shí)填寫(xiě)時(shí)鐘校對(duì)記錄,計(jì)量室管理員復(fù)核。

5. 使用部門(mén)如發(fā)現(xiàn)時(shí)鐘不能正常運(yùn)行,應(yīng)及時(shí)通知計(jì)量室安排維修,維修后需經(jīng)過(guò)重新校對(duì)。

6. 時(shí)鐘校準(zhǔn)誤差不應(yīng)超過(guò)±5分鐘

 

在國(guó)外,也有制藥公司在SOP中規(guī)定如下:

 

Procedure

校準(zhǔn)程序

 

The user department shall collect the master clock to verify the equipment and instrument clocks, and other clocks under the scope of this SOP. Before the use of a master clock to verify other clocks, the master clock must have to be verified for its accuracy. This verification shall be done as per the frequency defined in the procedure.

 

使用部門(mén)應(yīng)收集主時(shí)鐘(標(biāo)準(zhǔn)時(shí)間),以確認(rèn)設(shè)備和儀器時(shí)鐘,以及本 SOP 范圍內(nèi)的其他時(shí)鐘。在使用主時(shí)鐘(標(biāo)準(zhǔn)時(shí)間)確認(rèn)其他時(shí)鐘之前,必須確認(rèn)主時(shí)鐘的準(zhǔn)確性。此確認(rèn)應(yīng)根據(jù)程序中定義的頻率進(jìn)行。

 

Master clock shall be verified and adjusted with central server clock (connected with world clock) with the help of IT personnel on the day of verification of clocks. The Master clock shall have a unique identification number.

 

在主時(shí)鐘校準(zhǔn)時(shí),應(yīng)在 IT 人員的幫助下,使用中央服務(wù)時(shí)鐘(與世界時(shí)鐘對(duì)接)對(duì)主時(shí)鐘進(jìn)行校準(zhǔn)和調(diào)整。主時(shí)鐘應(yīng)具有唯一的標(biāo)識(shí)號(hào)。

 

Verification of the master clock shall be managed by the engineering department. The record shall be maintained for this verification and harmonization if any.

 

主時(shí)鐘的確認(rèn)應(yīng)由工程部門(mén)管理。確認(rèn)和校正(如有)過(guò)程應(yīng)有記錄。

 

After completion of master clock verification and time harmonization, hand over the clock to the user department for clock verification.

 

完成主時(shí)鐘確認(rèn)和時(shí)間校正后,將時(shí)鐘交給使用部門(mén)進(jìn)行時(shí)鐘確認(rèn)。

 

User department shall verify the timing of departmental clocks and record for the same shall be maintained.

 

使用部門(mén)應(yīng)確認(rèn)部門(mén)時(shí)鐘的時(shí)間,并保留相同的記錄。

 

In case of time difference observed more than 30 seconds, it shall be harmonized with the help of the engineering/ IT department. Record for the adjustment shall be maintained.

 

如發(fā)現(xiàn)時(shí)間誤差超過(guò) 30 秒,則應(yīng)在工程/IT 部門(mén)的幫助下進(jìn)行校正。應(yīng)保留校正記錄。

 

Clock verification shall also be done in case of any maintenance done on the equipment where the clock is maintained and maintenance may have a potential impact on the computerized controls. For example, equipment PC, HMIs (Human Machine Interface), instruments, etc.

 

如對(duì)具有時(shí)間顯示的設(shè)備進(jìn)行任何維護(hù),并且維護(hù)可能會(huì)對(duì)計(jì)算機(jī)控制產(chǎn)生潛在影響,也應(yīng)進(jìn)行時(shí)間驗(yàn)證。例如,設(shè)備 PC、HMI(人機(jī)界面)、儀器等。

 

After completion of maintenance activity, the system should be verified using the master clock by the engineering and user department.

 

維護(hù)活動(dòng)完成后,工程和使用部門(mén)應(yīng)使用主時(shí)鐘對(duì)系統(tǒng)進(jìn)行確認(rèn)。

 

While verification of the above clocks if required, time harmonization may need to be done. The harmonization should be done as directed in the following table.

 

如需要,在驗(yàn)證上述時(shí)鐘的同時(shí),可能需要進(jìn)行時(shí)間調(diào)校。調(diào)校工作應(yīng)按照下表進(jìn)行。

  • Noted Gap between the master clock and   clock under verification

    主時(shí)鐘與被校準(zhǔn)時(shí)鐘之間的偏差

    Required action

    采取措施

    Less than or equal to 30 seconds

    小于或等于30秒

    No action required

    無(wú)需措施

    31 seconds to 120 seconds

    31 秒到 120 秒

    Time adjustment as per master clock

    根據(jù)主時(shí)鐘校正時(shí)間

    More than 120 seconds

    超過(guò) 120 秒

    Non-conformance and investigation to   understand the impact of an occurrence.  Corrective Action and   Preventive Actions to eliminate the root cause and other potential areas with   similar possibilities.

    不合格并調(diào)查,以了解事件的影響。 糾正措施和預(yù)防措施,以消除根本原因和其他具有類(lèi)似可能性的潛在區(qū)域。

  •  

    After completion of the clock verification activity, the master clock shall be re-verified against the central server timing.

     

    完成時(shí)間確認(rèn)活動(dòng)后,應(yīng)根據(jù)中央服務(wù)時(shí)間重新確認(rèn)主時(shí)鐘。

     

    Clock timing shall be adjusted in the format, HH:MM: SS in 24 Hour format. In case of this format is not possible in any of the equipment/systems, it shall be adjusted as per the applicable setting for the clock.

     

    時(shí)鐘應(yīng)以 24 小時(shí)格式的 HH:MM: SS 進(jìn)行調(diào)整。如果任何設(shè)備/系統(tǒng)無(wú)法采用這種格式,則應(yīng)根據(jù)時(shí)鐘的適用設(shè)置進(jìn)行調(diào)整。

     

    Frequency

     

    頻率

     

    Equipment, instrument and digital clocks (Non GPS) – Monthly

     

    設(shè)備、儀器和數(shù)字時(shí)鐘(非 GPS)– 每月

     

    GPS clock, server connected clock and computerized systems – Six monthly

     

    GPS 時(shí)鐘、服務(wù)器連接時(shí)鐘和計(jì)算機(jī)化系統(tǒng) – 六個(gè)月

     

    Master clocks used for verification – before and after verification of other clocks

     

    主時(shí)鐘 – 確認(rèn)其他時(shí)鐘之前和之后

     

    JJF2199 - 2025 數(shù)字式時(shí)鐘校準(zhǔn)規(guī)范

     

    近日,全國(guó)時(shí)間頻率計(jì)量技術(shù)委員會(huì)發(fā)布了JJF2199 - 2025 數(shù)字式時(shí)鐘校準(zhǔn)規(guī)范,適用于數(shù)字式時(shí)鐘的校準(zhǔn),也適用于其他以數(shù)字形式顯示時(shí)間信息裝置的校準(zhǔn)。其中對(duì)數(shù)字式時(shí)鐘的校準(zhǔn)作了如下規(guī)定:

     

    顯示時(shí)刻誤差:

    復(fù)校時(shí)間:建議復(fù)校時(shí)間間隔為 12 個(gè)月

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    來(lái)源:GMP辦公室

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