Consideration on OOS Analysis Work Based on the Requirements of WHO Benchmarking of the Assessment of the National Regulatory Authority for Vaccines
As China has passed the WHO assessment of the National Regulatory Authority(NRA)for vaccines and has advanced in building national lot release capacity,an increasing number of provincial drug control laboratories are joining the vaccine lot release system.This article aims to discuss the key areas of focus and potential confusion in out-of-specification(OOS)analysis work based on the requirements of WHO benchmarking of the assessment of NRA for vaccines and other major international regulations or guidelines,in order to provide insights for relevant personnel.
vaccineWorld Health OrganizationNational Regulatory Authorityout-of-specificationregulationsguidelines
国家科技期刊平台
NSTL
万方数据
