Continued Process Verification for COVID-19 Vaccine Formulation and Packaging (recombinant)

Paulo Silva, Pedro Correia, Daiane Grugel, Victor Ferreira, Rayane Gonçalves
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Abstract

period of less than 1 year of production, as 391 batches were produced. All variables evaluated are under control or on alert. As this is a new product, it is understood that some variations may be inherent to the process and therefore, all will continue to be evaluated on a quarterly basis until completing the period of one more year for the evaluation of phase 3b of the CPV.
COVID-19疫苗制剂和包装(重组)继续工艺验证
生产周期不到1年,共生产391批。所有被评估的变量都处于控制或警戒状态。由于这是一种新产品,可以理解的是,过程中可能存在一些变化,因此,所有这些变化将继续以季度为基础进行评估,直到完成CPV阶段3b的一年多的评估期。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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