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			<div id="newshow-title">药物制剂开发研究流程</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">
	药物制剂开发研究流程
</h1>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="color:#0052ff;"><strong>一、前期准备工作（处方前研究）</strong></span>
</p>
<p style="font-size:16px;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;text-align:center;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="color:#0052ff;"><strong></strong></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="color:#0052ff;"><span style="font-size:16px;"><strong>1、文献检索</strong></span>，</span>如果是三类 or 六类，通过文献检索查询国外处方构成，有那些<span>成分如稀释剂是什么，润湿剂，黏合剂是什么等等，常用的文献检索工具有各国家药典，Merck 索引，FDA，EMEA， Drugfuture，百度，Google（千万不要小看百度和 google ，这两个异常强大）等网络工具。通过这些资料的收集，能对原料药和其制剂的专利家族信息，原料药测试方法，药物杂质，溶出方法等进行充分的了解，对后续的工作有指导意义。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;color:#0052ff;"><strong>2、参比制剂的购买</strong></span><span style="font-size:16px;">，必须是原研厂家可做参比药物的规格，例如本品种为 300mg，<span>最好能每个规格选择至少 3 批不同批号的产品用于对照制剂研究。评价的项目有片形，颜色，刻字，包装规格，包装材质，密封系统，棉花和干燥剂，片重，厚度，硬度，水分含量，脆碎度，崩解时限，含量，杂质等。</span></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;color:#0052ff;"><strong>3、辅料采购</strong>，</span><span style="font-size:16px;">对原研药处方组成进行分析后确定使用了的辅料，同时采购可能<span>需要用到的辅料。</span></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;color:#0052ff;"><strong>4、包装材料的采购</strong><span>，</span></span><span style="font-size:16px;">参照原研厂家的包装，并结合目前国内及公司本身情况，拟定包材种类，进行采购。<br />
</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="color:#0052ff;"><strong>5、API 的采购</strong><span style="font-size:16px;">，</span></span><span style="font-size:16px;">同时进一步了解原料药理化性质，如结构式，分子量，晶型，结晶习惯，溶解度，稳定性，LogP， PKa，熔点，粒径分布，堆/实密度，可压缩性，流动性，吸湿性，比表面积等一列的数据。评价原料药稳定性数据，残留溶剂，原料药的质量标准，原料药的含量，杂质等。注意化学纯度和光学纯度，可以以先采购小样，然后检测择优选择。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="color:#0052ff;"><strong>6、API<span>与辅料的配伍研究</span>，</strong></span><span style="font-size:16px;">&nbsp;原料采购回后，测定其物理化学性质后，重点考察其稳定性及与辅料的配伍研究。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">I根据文献资料所述，选择合适的辅料同原料药按照一定的比列，在不同的外界条件下进行该实验，目的在于在较短时间内寻找到同原料药搭配相对比较稳定的辅料。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">II：（差示扫描热分析 DSC）测量药物热焓和温度随程序温控的变化。具体研<span>究药物纯度，多晶形及亚稳态，无定形态。快速检测原料药同辅料之间是否有反应。</span></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
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	<span style="font-size:16px;">III：（高效液相分析 HPLC）将不同加速条件下得到的样品进行检测，确认是<span>否有降解产物产生。经过该步骤的分析检测，以及数据综合分析，基本确定在处方筛选中所用的辅料种类。尽量选用原创药同样的物料。固体制剂，辅料允许和原创药不同。注射剂，辅料必须同原创药一致。</span></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="color:#78acfe;"><strong><span style="font-size:14px;">（注：以上包材 &nbsp;，辅料采购规格都需药用级。）</span></strong></span>
</p>
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	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="color:#0052ff;"><strong>二、处方工艺研究</strong></span>
</p>
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	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;color:#0052ff;"><strong>1、原料 API，辅料检验，出具检验报告书</strong>。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
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	<span style="font-size:16px;color:#0052ff;"><strong>2、参比制剂的检验</strong></span><span style="font-size:16px;">，对参比制剂进行全面的检测。本制剂为片剂，故对参比<span>制剂的含量、有关物质、溶出度（溶曲）进行了研究，确定研究目标。</span></span>
</p>
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	<br />
</p>
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	<span style="font-size:16px;color:#0052ff;"><strong>3、制粒工艺选择：</strong></span><span style="font-size:16px;">由于原料药本身的可压性和流动性均较差，因此剂量较小的药物，可以<span>忽略原料药的可压性和流动性而直接采用直接压片。而对于剂量较大的药物，可以通过湿法制粒来改善其流动性和可压性，下表列出适合直接压片和湿法制粒的药物规格范围供参考。当然具体还要根据药物的理化性质来确定。</span></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">I：（直接压片）直接压片工艺关键在于辅料的选择。主要考查混合均匀性，流动性和可压性等，当然也包括其它必检项目如含量，杂质，溶出等。</span>
</p>
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	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">II：（湿法制粒）选择合适的混合设备和批量，预混时间，制粒所需的润湿</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">剂用量，制粒终点的确定，水分的限度，干燥温度的选择，干燥时间和水分的量<span>化关系等。颗粒的测试和片的检测项目项目同直接压片。</span></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">注：目前研发的产品大多倾向于用直接压片的方法，其优点在于耗时短，工<span>艺可靠性高，粉尘可控，劳动强度小。</span></span>
</p>
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	<br />
</p>
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	<span style="font-size:16px;"><span>II</span>I：直接压片 &nbsp;湿法制粒</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">规格 &nbsp;片重范围 &nbsp;规格 &nbsp;片重范围</span>
</p>
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	<span style="font-size:16px;">1-5 mg &nbsp;100-140 mg &nbsp;0.5-50 mg &nbsp;100-200 mg</span>
</p>
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	<span style="font-size:16px;">6-10 mg &nbsp;200-280 mg &nbsp;100-250 mg &nbsp;300-550 mg</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">20 mg &nbsp;300 mg &nbsp;750 mg &nbsp;850-980 mg</span>
</p>
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	<br />
</p>
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	<span style="font-size:16px;"></span>
</p>
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	<br />
</p>
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	<span style="color:#0052ff;"><strong><span style="font-size:16px;">4、辅料相容性试验</span></strong></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">取参比制剂中的辅料及可能用到的辅料，将辅料与主</span>
</p>
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	<span style="font-size:16px;">药按一定比例混合，取一定量，参照药物稳定性指导原则中影响因素的实验方法，<span>在高温 60 度、强光、高湿（RH75%、RH92.5%）试验。分别于 0 天、5 天、10天取样。重点考察性状、有关物质等。</span></span>
</p>
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	<br />
</p>
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	<span style="font-size:16px;color:#0052ff;"><strong>5、处方筛选（单因素试验）</strong></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">I：首先选择参比制剂的处方初步确定了自己的处方（两者相同）。</span>
</p>
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	<span style="font-size:16px;">II：确定了初始处方后对各辅料的量进行初步确定（主药是稀释剂）。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">III：对处方中的黏合剂、润滑剂等的用量进行考察，确定各自用量（指标：<span>可压性、流动性及药片的硬度、脆碎度、水分、溶出曲线等）。</span></span>
</p>
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	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;color:#0052ff;"><strong>6、工艺研究及优化</strong></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">对影响制剂产品质量的工艺参数等进行研究，如：混合工艺，制粒用的</span>
</p>
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	<span style="font-size:16px;">筛网大小，压片的初步工艺，包衣工艺，包衣增重等。确认两个或三个</span>
</p>
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	<span style="font-size:16px;">最佳处方工艺，分别作出小样，和原研产品对比进行影响因素研究，初</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">步确定处方工艺。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">以湿法制粒为例，处方优化需要评价项目有：</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">I：制粒过程的优化</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">制粒混合时间，搅拌桨和切刀速度，润湿剂的加入速率和用量，整粒</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">目数的选择，颗粒粒径分布同压片的关系。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">II：干燥的优化</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">干燥温度范围的选择和水分含量的限度范围。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">III：混合优化</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">颗粒中各组分的混合时间，不同混合时间对含量均匀性的影响，润滑</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">剂种类、用量和混合时间对溶出释放的影响。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">IV：压片优化</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">硬度对片的影响，如脆碎度，溶出度等。硬度范围的选择。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">V：包衣优化</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">包衣设备的速度，喷浆速度，喷枪同片床的高度，进风和出风温度控</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">制，片床温度控制，蠕动泵速度，包衣增重取样检测，包衣增重同时</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">间的关系，包衣后片硬度的变化研究。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">VI：处方的确定与初步稳定性研究</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">通过上面的优化结果，初步确定最终处方。</span><span style="font-size:16px;">按照初步确定的最终处方，将实验室所得样品放初步稳定性研究。</span><span style="font-size:16px;">根</span><span style="font-size:16px;">据所得稳定性研究数据，初步制定产品内控质量标准。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;color:#0052ff;"><strong>7、初步处方工艺验证与确认</strong></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">初步验证工艺及生产工艺的确认和关键批<span>工艺确认批和工艺放大批应作为单独的批次来评价用拟定的处方工艺生产三批，并与参比制剂的进行对比研究，看是否与参比制剂质量一致？产品合格，确定处方工艺；产品不合格，则重新进行处</span></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;color:#0052ff;"><strong>8、处方工艺筛选。</strong></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;"><span>I：</span>工艺确认批</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">本批的生产是为了检查在生产过程中是否还有问题出现，允许在关键批</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">生产前解决生产过程中出现的问题，其批量可以等同于放大批的批量，</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">或 70%关键批批量，或 10%商业批的批量。在这个阶段，要充分准备</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">生产所需的所有主文件和工艺规程，并被 QA 批准。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;"><span>II：</span>关键批</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">本批是向官方递交资料的基础，因此可以说是最重要最关键的一批，</span><span style="font-size:16px;">本批将用于生物等效性研究，正式稳定性研究。因此在进行本批生产前要进行充分的准备。本批生产将涉及到研发、生产、QA、QC 以及注册等各个部门。在正式生产前，应对涉及的所有生产以及 QA 人员进行有效培训，严格控制生产过程中的各个关键点。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="color:#0052ff;"><strong><span style="font-size:16px;">9、中试生产及工艺验证（现在一般公司都采用同步验证）</span></strong></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">根据公司条件及相关指导原则，拟定中试生产和工艺验证。连续生产 3 批</span><span style="font-size:16px;">商业批产品，用于验证。主要是为了验证在连续的生产条件下，所得产品可以很好的符合产品质量标准，满足工业化的大生产。完成验证报告。所得产品用于稳定性试验。</span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="color:#0052ff;"><strong>三、生物等效性研究</strong></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">用关键批生产所得产品进行生物等效性研究。一般来讲，选择产品最高规格<span>用于该步研究。还有一种就是根据 BCS 分级，属于Ⅰ级别以及部分属于 III级别中，在 4 种不同 pH 溶出介质中，15 分钟溶出超过 85%，可以免做 BE研究。</span></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="color:#0052ff;"><strong>四、注册</strong></span>
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<br />
</p>
<p style="font-size:16px;font-family:-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:#222222;font-style:normal;text-align:justify;background-color:#ffffff;text-indent:0px;">
	<span style="font-size:16px;">通过研发报告，审核所有研发数据，生产场地和实验室文件，QA 系统。</span><span style="font-size:16px;">总结所有数据，准备资料递交官方审核。及时回复官方不足信问题。准备并签署验证草案和验证文件。</span>
</p>
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