预定规格 meaning in English

predefined specification

The aim of the validation report is to explain the operations performed in order to provide the documented evidence that the manufacturing process of gemcitabine provides consistenly , with a high degree of assurance the production of an api meeting its predetermined specifications and quality attributes
验证报告的目的是去解释所做的操作,目的是为了提供文件根据,证明吉西的制造工艺能提供坚固的,高水平的,能满足它的预定规格和质量品质的原料产品