混粉验证PQ阶段是测试含量均匀度还是粒度分布均匀度呢？
好象先阶段都是 以含量均匀度的多点也有说服力，粒度分布 因为每次的颗粒大小有细微差别都会引起较大误差,所以取的少.
含量均匀度的标准是多少？RSD2%？
依据FDA 工业指南：“Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment”中所述，如下：
We recommend that during the manufacture of exhibit and process validation batches, you assess the uniformity of the powder blend, the in-process dosage units, and the finished product independently. We recommend you use the following steps to identify sampling locations and acceptance criteria prior to the manufacture of the exhibit and/or validation batches.
建议在工艺展示批次及工艺验证批次生产中，分别评价粉末混合均匀度、中控制剂单位以及终产品制剂单位均匀度。推荐使用以下步骤来确定取样方案和可接受限度：
1. Carefully identify at least 10 sampling locations in the blender to represent potential areas of poor blending. For example, in tumbling blenders (such as V-blenders, double cones, or drum mixers), samples should be selected from at least two depths along the axis of the blender. For convective blenders (such as a ribbon blender), a special effort should be made to implement uniform volumetric sampling to include the corners and discharge area (at least 20 locations are recommended to adequately validate convective blenders).
1.谨慎地在总混机中选定10个取样位置，必须能够代表最差混合区域。例如：在翻斗混合机（V－型，双锥型，或鼓型混合机），必须选择至少两个沿转轴的不同深度地取样点；······
2. Collect at least 3 replicate samples from each location. Samples should meet the following criteria:
2.在每个取样点至少取样3份。样品应符合以下标准：
． Assay target=_blank>Guidance for Industry.pdf (296.81k)
多谢楼上筒子，呵呵，我总是不会传附件，寒！
多谢wingzcw深度分析，但是我们指得是API的混粉工艺，而且含量均匀度确实是已经做了，但是几个国际大公司的QA来审计，还是提出考察粒度分布均匀度的要求？
还有其他相关指南吗？或者宝贵建议。
万分感谢
好象先阶段都是 以含量均匀度的多点也有说服力，粒度分布 因为每次的颗粒大小有细微差别都会引起较大误差,所以取的少.
含量均匀度的标准是多少？RSD2%？
依据FDA 工业指南：“Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment”中所述，如下：
We recommend that during the manufacture of exhibit and process validation batches, you assess the uniformity of the powder blend, the in-process dosage units, and the finished product independently. We recommend you use the following steps to identify sampling locations and acceptance criteria prior to the manufacture of the exhibit and/or validation batches.
建议在工艺展示批次及工艺验证批次生产中，分别评价粉末混合均匀度、中控制剂单位以及终产品制剂单位均匀度。推荐使用以下步骤来确定取样方案和可接受限度：
1. Carefully identify at least 10 sampling locations in the blender to represent potential areas of poor blending. For example, in tumbling blenders (such as V-blenders, double cones, or drum mixers), samples should be selected from at least two depths along the axis of the blender. For convective blenders (such as a ribbon blender), a special effort should be made to implement uniform volumetric sampling to include the corners and discharge area (at least 20 locations are recommended to adequately validate convective blenders).
1.谨慎地在总混机中选定10个取样位置，必须能够代表最差混合区域。例如：在翻斗混合机（V－型，双锥型，或鼓型混合机），必须选择至少两个沿转轴的不同深度地取样点；······
2. Collect at least 3 replicate samples from each location. Samples should meet the following criteria:
2.在每个取样点至少取样3份。样品应符合以下标准：
． Assay target=_blank>Guidance for Industry.pdf (296.81k)
多谢楼上筒子，呵呵，我总是不会传附件，寒！
多谢wingzcw深度分析，但是我们指得是API的混粉工艺，而且含量均匀度确实是已经做了，但是几个国际大公司的QA来审计，还是提出考察粒度分布均匀度的要求？
还有其他相关指南吗？或者宝贵建议。
万分感谢