参考21 CFR 211.84(b) Representative samples of each shipment of each lot shall be collected for testing or examination. The number of containers to be sampled, and the amount of material to be taken from each container, shall be based upon appropriate criteria such as statistical criteria for component variability, confidence levels, and degree of precision desired, the past quality history of the supplier, and the quantity needed for analysis and reserve where required by § 211.170. 原辅料包括包材代表性样品取样要求，提及需要取留样，具体留样的要求，可以再参考211.170。所以原辅料以及包材需要留样。单看211.170可能会以为只有原料和成品需要留样。

21CFR 314.50(e)有明确提到包材的留样，其中原话是：如果FDA要求，则需提供finished market package市售终产品包装，供参考。所以保险起见，还是要留一下包材的样，但对于留多少，就没有明确说了。

你看一下CFR 211.170 Reserve Samples