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新闻最终页显示函数 调用格式如：getnewsend
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bgcolor     表格单元格的背景色
Fstyle      字体样式
pageNum     每页显示的记录数
mnum        多少页为一段
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会员登录函数(左右侧) 调用格式如：GetUserLogin "reg.asp"
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txtstyle   文本框样式
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会员注册提交表单函数 调用格式如：GetUserLogin3 "input","bor1"
txtstyle   文本框样式
treastyle  多行文本框样式
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			<div id="newshow-title">【问答】关于清洁验证</div>
				<div id="newshow-time">发布人：网站管理员　发布时间：2023-4-26　点击：142次</div>
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				  <h1 id="activity-name" class="rich_media_title " style="font-size:22px;font-family:system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-weight:400;color:;font-style:normal;background-color:#ffffff;text-indent:0px;" align="center">
	【问答】关于清洁验证
</h1>
<p class="rich_media_title " style="font-size:22px;font-family:system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-weight:400;font-style:normal;background-color:#ffffff;text-indent:0px;" align="left">
	<span style="font-size:32px;font-family:Tahoma;color:#337fe5;background-color:#ffffff;"><strong>01</strong></span>
</p>
<p>
	<span style="font-size:15px;color:#021eaa;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">问：公司什么时候需要进行清洁验证/再验证？什么时候不需要？</span></strong></span>
</p>
<p>
	<span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"><span style="color:#000000;"><strong>答：</strong></span>原料药设施</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">中多种产品使用设备的清洗过程受清洗验证要求的约束。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">验证工作量是巨大的。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">为了最小化所需的验</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">证量，可以使用验证最坏情况的方法。</span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">公司应单独检查每一种情形，决定是否需要验证。</span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">重新验证清洗程序的必要性应根据变更控制参数确</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">定。</span></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">如果使用</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">了日常确认程序，则应对这些程序进行监控，以确保程序处于受控状态。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">公司应考虑定</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">期评估清洁程序，这可能会发生变化(例如人工程序等)，作为额</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">外的预防措施，以确保程序仍然有效。</span></span>
</p>
<p>
	<br />
</p>
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	<span style="color:#337fe5;">02</span>
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#021eaa;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"><span style="color:#337fe5;">问：</span><span style="color:#337fe5;">什么情况下使用前验证，同步验证和回顾验证？</span></span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">答：</span></strong></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">药监当局不认可对清洁方法进行回顾性验证。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">前验证是理想的验证方法。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">如果在给定的时间段内只生产较少的批次，且/或已从业务角度决定了清洁后的下一批生产物料</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">将对设</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">备存有较高水平测试（即验证水平）后才放行，则可以在验证同时放行物料。</span></span>
</p>
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	03
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#021eaa;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">问：清洁验证后的检测要求是怎样的？</span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#000000;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"><strong>答：</strong></span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">对此问题的回答取决于各不同情形。</span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">一般来说，公司先进行目视检查，然后以预定的间隔（时间或批次）取淋洗样品检查清洁的有效性。如果公司决定在验证后一直实施清洁检查，可以采用非专属性且科学合理的方法。</span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"><br />
</span><strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#d92142;">以下给出了清洁验证完成后，较为实用的对清洁有效性进行监控的有效且科学合理的便宜方法：</span></strong>
</p>
<p>
	<strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#d92142;"></span></strong><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">1）对清洁后的设备进行目视检查。此检查符合要求后，方可进入下一步。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">2）取一个淋洗样和/或擦拭样品（一般使用一升淋洗样）</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">3）使用旋转蒸发器将约500ml 样品在小烧瓶中蒸干检测蒸发残留。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#888888;">&nbsp;&nbsp;&nbsp;&nbsp; 该非专属方法包括了无机盐、已知或未知有机产品，可以检出总残留。（烘干设备不需要做此项测试，此时，设备中只有纯的原料药或中间体，一般没有潜在的副产物、降解产物等）。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#888888;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">4）如果结果符合标准，则可以采用特定的技术（色谱法）。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#888888;">&nbsp;&nbsp;&nbsp;&nbsp; 从 TLC 限度测试开始（便宜且易于验证，具有较宽的检测范围----紫外和特定衍生产品---如果将这些技术合并，方法会对可能出现在样品中的不同杂质具有专属性），测试 2 个样品，一个是最后洗涤液（检查所有潜在残留物），一个是淋洗液（检查实际残留），测试2个标准品，一个是认为可能残留的产品，浓度为可接受的限度，另一个是 1：2稀释的标准品。如果淋洗液中的主斑点不深于标准，则认为设备已清洁。第二个标准品是用来确认检测限的。</span>
</p>
<p>
	<span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#888888;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">5）如果 TLC 不适用，改成 HPLC 或 GC。</span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>
</p>
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	04
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#021eaa;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">问：在清洗验证期间需要查看哪些关键参数?</span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">答：</span></strong></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">重要的是，设备</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">设计要与要清除的产品残留物、可用的清洗剂和清洗技术一起进行详细评估此外</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">，清洗程序的耐用性和重现性也应包括在内。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>
</p>
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	05
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#021eaa;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">问：要验证一个清洁程序，需要重复几轮清洁？</span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">答：</span></strong></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">一个</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">验证程序一般是经过三次连续成功的重复。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">但是，公司应对各种情形进行单独评估。</span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">
</p>
</span> 
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	06
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#021eaa;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">问：是否可以重复一个经过验证的清洁操作直至分析结果显示其已清洁？</span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">答：</span></strong></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">药监当局不接受这种方法。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">如果检测结果不符合可接受标准，则需要进行调查，找出</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">可能的根本原因。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">必要时，应对操作人员进行再次培训，和/或对清洁程序进行调整以解决问题。</span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">
</p>
</span> 
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	07
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#021eaa;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">问：公司是否有必要验证清洁前的最大允许放置时间？</span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#021eaa;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"><span style="color:#000000;">答：</span><span style="color:#000000;"></span></span></strong></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">公司应该有标准操作规程，要求在生产停止后立即进行清洁。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">应该验证这种情况。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">然而，如果由于某些原因不能立即清洗，公司应考虑时间对沉积在设备上的物料的影响。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;">可以对产品进行“分组”或“分类”，验证最坏的情况。</span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">
</p>
</span> 
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	08
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<span style="font-size:15px;color:#021eaa;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">问：公司是否有必要验证清洁后到使用前的最大允许放置时间？</span></strong></span><span style="font-size:15px;color:#021eaa;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">如果设备不常用，是否有必要建立清洁的时间限？<span style="color:#000000;">答：</span></span></strong></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="color:#000000;">公司应制定标准操作规程，以确保设备部件在清洗后得到充分保护，不受任何污染，即确保设备被充分覆盖，关闭以防止灰尘等。如果公司觉得在清洁后的“闲置时间”有任何污染的风险，应该考虑验证。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span><br />
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	<span style="color:#337fe5;">09</span>
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"><span style="color:#003399;">问：</span><span style="color:#003399;">用水最后一遍淋洗后，最长允许时间是多少？</span></span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">答：</span></strong></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">设备清洁后不应该有水。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">清洁程序的最后一步应该包括使用溶剂或氮气吹干，来确保不会有微生物生长。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"></span>
</p>
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	<span style="color:#337fe5;">10</span>
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"><span style="color:#003399;">问：</span><span style="color:#003399;">设备是否可能随着时间的推移而发生劣化，从而使原始验证结果失效?</span></span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"></span></strong></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"><span style="color:#000000;"><strong>答：</strong></span>用于制药/化学工业设备制造的材料是非常高标准的。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">然而，作为预防性维护计划的一部分，使用的设备材料应进行评估，以确保其长期耐用性。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">应考虑表面粗糙度的可能性及其对清洗可能产生的任何影响。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">公司应该监控验证后确认所产生的所有数据，作为程序的一部分。</span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">
</p>
</span> 
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	<span style="color:#337fe5;">11</span>
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"><span style="color:#337fe5;">问：</span><span style="color:#337fe5;">如果一个公司已经验证了一个最坏的情况</span></span></strong></span><span style="font-size:15px;color:#337fe5;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#337fe5;">(分组或分组制度)</span></strong></span><span style="font-size:15px;color:#337fe5;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#337fe5;">他们是否还需要验证一个“较小”的最坏情况？</span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"></span></strong></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"><span style="color:#000000;"><strong>答：</strong></span>当对产品进行分组并确定验证的最坏情况时，公司应确定验证的最坏情况是否为一种，这适用于常规生产。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">出于操作上的原因，对某些产品验证“不那么严格”的清洗程序可能</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">是有益的。</span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">
</p>
</span> 
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	<span style="color:#337fe5;">12</span>
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"><span style="color:#003399;">问：</span><span style="color:#003399;">一个没有降解而且专用的工厂，是否需要验证？</span></span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"></span></strong></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"><strong>答：</strong>公司应</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">该单独考虑每一种情况，并确认哪里有潜在的污染。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">在上述情况下，可能没有必要。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">但是，应该考虑在完全清洗之前进行的连续生产批次数。</span></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">
</p>
</span> 
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	<span style="color:#337fe5;">13</span>
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"><span style="color:#003399;">问：</span><span style="color:#003399;">清洁验证需要是研发计划的一部分吗？</span></span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">答：</span></strong></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">ICH 没有要</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">求在研发阶段进行清洁验证，但是以下需要考虑：</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">如果设备在用于研发产品生产后，又用于生产商业化产品，或用于人用药品例如临床试验药品生产，则需要确认设备再次使用前已被适当清洁。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">产品清洁程序应该在产品研发，可以商业化生产时建立。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">清洁程序验证应在工艺验证周期时进行，或至少开始。</span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">
</p>
</span> 
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	<span style="color:#337fe5;">14<strong></strong></span>
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"><span style="color:#003399;">问：</span><span style="color:#003399;">在使用设备进行生产之前，</span></span></strong></span><span style="font-size:15px;color:#003399;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#003399;">我们是否必须等待擦拭和淋洗样品得到批准?</span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#000000;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"><strong>答：</strong></span></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">在清洗验证研究期间，建议等待所有计划测试完成后再放行设备以供进一步使用(以便在测试失败时能够进行调查)。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">在日常操作中(在验证完成后)，可以在测试结果(验证、监测测试状态)之前发放设备。</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">使用待放行设备的责任和情况应在公司内</span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">部定义。</span></span><br />
<img alt="" src="/upfile/image/20230426/20230426151683588358.png" />
</p>
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	<span style="color:#337fe5;">15</span>
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"><span style="color:#003399;">问：</span><span style="color:#003399;">清洁验证一定要包含微生物测试吗？</span></span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">答：</span></strong></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">如果下一产品需要有较低的微生物负荷，也取决于使用的清洁剂，如果后续产品有微生物污染的风险(例如，如果最终清洗使用水)。</span></span><span style="font-size:15px;font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">
</p>
</span> 
<p style="font-size:31px;font-family:AlibabaPuHuiTi_2_95_ExtraBold;font-weight:bold;color:#3a79d5;">
	<span style="color:#337fe5;">16</span>
</p>
<p style="font-size:16px;font-family:PingFangSC-Semibold, &quot;PingFang SC&quot;;font-weight:bold;color:#ffffff;">
	<br />
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;"><span style="color:#003399;">在清洗验证研究中应该使用哪些分析方法</span></span></strong></span><span style="font-size:15px;color:#003399;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#003399;">(只接受 HPLC 测试吗?</span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#003399;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#003399;">问：这些方法应该在何种程度上进行验证?</span></strong></span>
</p>
<p>
	<span style="font-size:15px;color:#000000;"><strong><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:#000000;">答：</span></strong></span><span style="font-size:15px;"><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="font-family:&quot;Helvetica Neue&quot;, Helvetica, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;color:;"></span><span style="color:#000000;">所有适用的检验方法都可以使用。清洁验证一般所用的检测方法为限度检测，方法验证要求较低（如 ICH-Q2A 和 Q2B 所列）。</span></span><span style="font-size:15px;"><br />
</span><span style="font-size:15px;color:#000000;">但是，如果公司决定要验证一个检验方法，用于一定范围内残留量的检测（例如，清除曲线，证明某个清洁步骤是否成功），其验证要求比起原料药放行检测方法的验证来说要低，例如可以建立线性和准确度。</span>
</p>
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