洁净室与公用系统

原料药生产设备

无菌生产设备包含冻干

手套箱系统与其灭菌作业

其他口服制剂/疫苗/化妆品/生物技术产品/合约生产/包装材料生产相关设备

URS - User Requirement Specification/FRS - Functional Requirement Specification/SDS - software design specification

IA - Impact Assessment (for Systems/Equipment/Component Criticality) & RA - Risk Assessment

DQ - Design qualification and design reviews

FAT (Factory acceptance tests) / SAT (Site Acceptance Test) / Commissioning documents

IQ - Installation qualification / OQ - Operational qualification / SOP - Standard operating procedures

PQ - Performance qualification / Summary Report / RQ - Re-qualification

包括总体确效主计划书撰写; 制程确效、无菌模拟、灭菌确效、清洁确效、方法确效、保持时间评估与软体系统确效的规划/执行/结果评估