WHO世界卫生组织：建立药物、疫苗和体外诊断的质量标准-2023年质量周培训工具包（英文版）

Ensuring quality of the health product ensures its safety and efficacy. Manufacturers in lowand middle-income countries (LMICs) face challenges to achieve quality in local production, such as the lack of an available manufacturing workforce trained in quality and understanding regulatory quality standards and difficulties in implementing a quality culture in the manufacturing facility.