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天平未進(jìn)行預(yù)熱或預(yù)熱時(shí)間不夠

FDA在對(duì)某公司的檢查中發(fā)現(xiàn)電子天平的預(yù)熱時(shí)間不充分，導(dǎo)致高活性原料藥。（HPAPI）稱量數(shù)據(jù)不可靠，具體問(wèn)題包括：

天平預(yù)熱缺失：

用于稱量基因毒性雜質(zhì)的超微量天平，未按制造商要求預(yù)熱。

操作員稱量記錄顯示，天平每日僅預(yù)熱XX分鐘即開(kāi)始使用。

天平等設(shè)備未進(jìn)行校準(zhǔn)

Your firm completed a balance calibration plan for xxx which states that calibration should be performed. However, your firm did not perform xxxx calibrations for the following mechanical instruments.

貴公司為xxx完成了天平校準(zhǔn)計(jì)劃，該計(jì)劃規(guī)定這些設(shè)備應(yīng)進(jìn)行校準(zhǔn)。但是，貴公司沒(méi)有對(duì)以下儀器進(jìn)行xxxx校準(zhǔn)。

- Xxxx sensor (ID:xxxx) 探頭xxxx

- Xxxx sensor (ID:xxxx) 探頭xxxx

- Balance (ID:xxxx) 天平xxxx

- Balance (ID:xxxx) 天平xxxx

In addition, these measuring instruments are used in the manufacturing process for xxxxx.

此外，這些測(cè)量?jī)x器用于xxxxx的制造過(guò)程。

You have not calibrated your weighing scales, nor the (b)(4) and (b)(4) mechanisms in your (b)(4) tank and (b) ⑷ tank.

你公司沒(méi)有校準(zhǔn)你們的稱量天平，也沒(méi)有校準(zhǔn)(b)(4)儲(chǔ)罐和(b)(4)儲(chǔ)罐中的(b)(4)和(b)(4)機(jī)構(gòu)。

天平確認(rèn)范圍未包含日常適用范圍

Analytical balance QCE # 684 with a weight range of 20 mg to 200 g is used in your firm's QC chemistry laboratory to weigh test samples. Your firm's(b) (4) verification of this balance includes only 50 mg to 200g weight range, and does not include the lower weight range of 20 mg to 50 mg.

貴公司的質(zhì)量控制實(shí)驗(yàn)室使用型號(hào)為 QCE # 684 的分析天平來(lái)稱量測(cè)試樣品，該天平的稱重范圍是 20mg至 200g。貴公司對(duì)這臺(tái)天平的（b）（4）項(xiàng)核查僅涵蓋 50mg至 200g的稱重范圍，并未包括 20mg至 50mg的較低稱重范圍。