理论上:
按中国药典9203《药品微生物实验室质量管理指导原则》中提到 “待检样品应在合适的条件下贮藏并保证其完整性,尽量减少污染的微生物发生变化”,“实验室在收到样品后应根据有关规定尽快对样品进行检查,”
美国药典<1117> Microbiological Best Practice 更具体一些,"it is important to minimize the amount of time between the sampling event and the initiation of testing and to control, as much as possible, the conditions.… For example, when monitoring water or bioburden prior to bioburden-reducing steps or sterilizing steps, samples may be held at 2°–8° for up to 24 h from the time of sample collection until the start of the analysis. When testing within 24 h is not possible (e.g., when contract laboratories are used), the actual maximum hold time between collection and testing should be supported by experimental studies (e.g., challenge tests). ”

实际上:
如USP中的举例,该情况主要针对微生物限度检测(或细菌内毒素)。对于生物制品的无菌检查实际上不成立——即便是长期稳定性样品,无菌检查也应符合规定(可通过检测容器密闭完整性间接证明),在合适的条件下样品多保存几天,对无菌检查的结论没有影响。
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