验证计划和风险评估

Planning and Risk Assessment for Validation

设计确认 & GMP审核

Design Qualification & GMP Review

工艺设备确认

Process Equipment Qualification

设施和公用系统确认

Facilities & Utilities Qualification

分析仪器确认和分析方法验证

Analytical Instrument Qualification & Analytical Method Validation

计算机化系统验证

Computerized Systems Validation

仓储及运输验证

Warehouse & Shipping Qualification

清洁验证

Cleaning Validation

工艺验证

Process Validation