潔淨室與公用系統

原料藥生產設備

無菌生產設備包含凍乾

手套箱系統與其滅菌作業

其他口服製劑/疫苗/化妝品/生物技術產品/合約生產/包裝材料生產相關設備

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

包括總體確效主計畫書撰寫; 製程確效、無菌模擬、滅菌確效、清潔確效、方法確效、保持時間評估與軟體系統確效的規劃/執行/結果評估