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Q7：

8.12 Critical weighing, measuring, or subdividing operations should be witnessed or subjected to an equivalent control. Prior to use, production personnel should verify that the materials are those specified in the batch record for the intended  intermediate or API.

關(guān)鍵的稱量、計(jì)量或分裝操作應(yīng)當(dāng)有復(fù)核或有類似的控制手段。使用前，生產(chǎn)人員應(yīng)當(dāng)核實(shí)所用物料正確無(wú)誤。

8.13 Other critical activities should be witnessed or subjected to an equivalent control.

其它關(guān)鍵操作也應(yīng)當(dāng)有復(fù)核或有類似的控制手段。

APIC - How to do ?

8.12 Companies should define the critical weighing, measuring or subdividing operations which should be witnessed or subject to an equivalent control to the minimum number General non-critical weighing or measuring of materials does NOT require witnessing.

企業(yè)應(yīng)明確需由第二人復(fù)核或?qū)嵤┑刃Э刂拼胧┑年P(guān)鍵稱量、計(jì)量及分裝操作，并將其數(shù)量控制在最低限度。對(duì)于常規(guī)的非關(guān)鍵物料稱量或計(jì)量操作，則無(wú)需進(jìn)行復(fù)核。

As it was seen in the step 2 ICH Q7 document it was intended that such weighing operations should be “supervised”, which would not have required the physical presence of a second person. However, the word “supervised” suggests that someone more senior in the organisation should carry out this task. To avoid this interpretation the word “witnessed” was chosen to indicate that anyone could carry out this check.

正如在ICH Q7中所規(guī)定，原本計(jì)劃此類稱重操作應(yīng)由他人“監(jiān)督”，但這并不要求必須有第二個(gè)人在場(chǎng)。然而，“監(jiān)督”一詞容易讓人誤解為需由組織中更高級(jí)別的人員來(lái)執(zhí)行此任務(wù)，為避免這種誤解，改用“見證/復(fù)核”一詞，以明確表示任何人皆可進(jìn)行此項(xiàng)檢查。

However, it was not intended that this word should be used within the narrow legal sense of being physically present throughout the operation and a subsequent check of a second person would fulfil the requirement.                                                     

然而，使用該詞并非意在將其含義局限于狹義的法律層面，即并非要求在整個(gè)操作過程中始終在場(chǎng)，而是由第二人在操作完成后進(jìn)行事后檢查即可滿足要求。

A typical equivalent control that avoids the need for a second person is a recording system where all weighing or measuring operations are detailed. The critical weights or volumes should be confirmed at the end of the batch production.

一種典型的等效控制方法（可避免第二人在場(chǎng)），是通過記錄系統(tǒng)詳細(xì)記錄所有稱量或計(jì)量操作。關(guān)鍵的重量或體積應(yīng)在批次生產(chǎn)結(jié)束時(shí)進(jìn)行確認(rèn)。

補(bǔ)充說(shuō)明：

1、所有需經(jīng)第二人復(fù)核或?qū)徍说挠涗?，?wù)必詳盡記錄（尤其是用于決策的信息），應(yīng)避免使用含糊不清的表述，以確保復(fù)核人或?qū)徍巳四芑谕暾畔⒆龀鰷?zhǔn)確判斷。

2、根據(jù)風(fēng)險(xiǎn)管理原則，針對(duì)高關(guān)鍵性數(shù)據(jù)，除了進(jìn)行實(shí)時(shí)記錄外，還需由同級(jí)人員實(shí)施實(shí)時(shí)復(fù)核（即“四眼原則”），并要求質(zhì)量部門進(jìn)行后續(xù)審核。例如，在向設(shè)備投料時(shí)，若稱量數(shù)據(jù)未通過電子方式采集且天平未連接打印機(jī)，則必須由一人負(fù)責(zé)記錄稱量值，另一人同步確認(rèn)實(shí)際加入設(shè)備的物料量無(wú)誤且記錄準(zhǔn)確。    

The final check by production that the identity and lot numbers of dispensed raw materials comply with the batch instructions may also include a check of the quantities or volumes of critical measurements These checks should be clearly defined in the operating instructions for each batch.                                           

生產(chǎn)部門需對(duì)已發(fā)放原料的身份和批號(hào)是否與批指令相符進(jìn)行最終核查，亦可涵蓋對(duì)關(guān)鍵計(jì)量指標(biāo)如量或體積的審核。此類檢查應(yīng)在每批產(chǎn)品操作規(guī)程中予以明確規(guī)定。

8.13 Companies should decide which operations other than weighing and dispensing could be considered critical and therefore should be witnessed or subject to additional controls. Examples are:                            

公司應(yīng)確定除稱量和分裝外還有哪些操作屬于關(guān)鍵操作，從而需進(jìn)行第二人復(fù)核或采取額外的控制措施。例如：

• Charging of critical raw materials.關(guān)鍵原料的投料；

• Control of critical temperatures, pressures, times.關(guān)鍵溫度、壓力、時(shí)間的控制；

• Point of crystallisation of API where this is critical to the control of polymorphs.對(duì)原料藥晶型控制至關(guān)重要的結(jié)晶點(diǎn)控制；

• Operations that are critical (and thus subject to these controls) should be documented on the Batch Production Records and related documents.

被認(rèn)定為關(guān)鍵操作（因此需執(zhí)行相應(yīng)控制措施）的步驟，應(yīng)詳細(xì)記錄在批生產(chǎn)記錄及相關(guān)文件中。