To begin with we will provide a brief background on the2Introduction1....
The principles of ... are applied as modularized criteriaClassification1. A xx system comprises three main components:2. Must decompose the original .. into a set of ..3....
•对新方法/技术的变更将需要执行适当的开发和确认活动(阶段1和阶段2),以证明新方法符合ATP。•影响ATP的变更,例如质量标准限度变更或需要应用方法测量原始ATP中未考虑的待测组分水平,需要对ATP进行更新,并对现有方法设计和确认数据(阶段1和阶段2)进行审查,以确定程序是否仍然满足新的ATP的要求。...
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