药品留样，不能随便“丢失”

文 / PharmLink读书组cGMP知识点在美国cGMP法规Part 211 中，I子部分的内容是实验室控制（Laboratory Controls）。其中170条谈到了有关留样的要求：§211.170 Reserve Samples 留样a. An appropriately identified reserve sample that is representative of each lot in each shipment of each active ingredient shall be retained. The reserve sample consists of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications, except for sterility and pyrogen testing.a. 应当保留留样，可以适当代表每次货运中每个批次。留样品至少包括：确定活性成分是否符合既定质量标准所需检验量的两倍，除无菌和热原检验外。本条款的目的是：在出现投诉或疑问时，使用产品留样进行评估。法规中未定义留样的实际 ………………………………