FDA指南Questions and Answers on Quality Related Controlled Correspondence回答了冻干粉针只需进行一种放样方向，我们一般进行最差条件的倒放

6. Orientation
Question 1:
If the generic drug product is a “for injection” (sterile lyophilized powder), can stability data for exhibit batches be generated using only one orientation?
Answer 1:
According to the FDA guidance for industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers (May 2014), “For primary batches of liquids, solutions, semi-solids, and suspensions, the product should be placed into an inverted (or horizontal) position and an upright (or vertical) position.” Since lyophilized powders do not fall under one of these categories, exhibit batches for drug products that are sterile lyophilized powders may be placed on stability in one orientation alone, provided that the ANDA submission includes an adequate justification for the orientation selected.

我以前做稳定性研究的时候，曾出现过粉末制剂倒置后浊度发生了变化；建议你看看研发时的稳定性研究数据，是否有倒置的？正放、倒置数据有没有区别，有数据支持才能确定是否需要倒置。

不清楚您问题中的产品类别，所以先补充一个生物制品的相关要求，ICH Q5C ：【6.5容器 /密闭系统  由于生物技术产品/生物制品制剂与容器 /密封系统的相互作用，制剂的质量可能会发生变化。如不能排除液体制剂与容器或闭塞物无相互作用（除密封安瓿这种包装形式外）时，应将样品以倒立放置、水平放置 即与容器密封系统接触和正立放置情况下进行稳定性研究，以确定容器密封系统对产品质量的影响。】，FDA自然是遵循ICHQ5C的。

但我觉得从科学逻辑上看，本质都是因为制剂同胶塞/其他包材可能存在相互作用，所以在稳定性考察阶段判断其对质量的影响，建议是进行考察。

——以上拙见，如有缺漏请指正。

冻干粉也存在粉末与胶塞接触的可能性，建议按照最差原则，注册批按照正置和倒置均进行考察，如果数据证明无差异，后续持续稳定性按照正置考察（这也与药品的实际储存、运输等状态一致），在WHO稳定性指南中有详细描述如下：

WHO Stability testing of active pharmaceutical ingredients and finished pharmaceutical products

The orientation of the product during storage, i.e. upright, on the side or inverted, as well as the rationale for the orientation, may need to be included in a protocol where contact of the product with the closure system may be expected to affect the stability of the products contained (e.g. liquids and semisolids), or where there has been a change in the container-closure system.