ISO13408-1, section10 process simulation

首先模拟灌装是要记录的，另外实际商业化生产肯定也是要记录的，不用纠结出自哪里的要求，从无菌风险的角度论，难道不记录？

此条是说上市生产的制剂批记录需记录这些干扰动作的法规出处，不是APS试验时。

欧盟GMP附录1 也提到了：

9.33       The APS should take into account various aseptic manipulations and interventions known to occur during normal production as well as worst-case situations, and take into account the following:

APS 应考虑到在正常生产以及最坏情况下已知发生的各种无菌操作和干预，并考虑以下内容：

i.        Inherent and corrective interventions representative of the routine process should be performed in a manner and frequency similar to that during the routine aseptic process. 代表常规过程的固有和纠正干预应以与常规无菌过程相似的方式和频率进行。

ii.        The inclusion and frequency of interventions in the APS should be based on assessed risks posed to product sterility. APS 中干预措施的包含和频率应基于对产品无菌造成的风险评估。

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