表1总结了无菌产品的范畴。
对于无菌产品的生产,SIP经常是无菌处理的关键环节,因此,可以从风险管理方法的应用中受益。
SIP is often a pivotal step of aseptic processing for sterile product manufacture, and as such, may benefit from the application of risk management methodologies.
作为药品生产单位,无菌注射剂生产中污染的控制及无菌检查直接影响到无菌产品的微生物方面的质量控制。
As to be the drag manufacturer, it will directly influence the biological quality control of sterility product that the contaminations control during injection production and sterility test.
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