FDA认证检查的六大系统

1 QUALITY SYSTEM质量保证系统1.1 Product reviews (annual) 产品审查(年度) 1.2 Complaint reviews (quality and medic

1QUALITY SYSTEM质量保证系统 1.1Product reviews (annual) 产品审查(年度) 1.2Complaint reviews (quality and medical) 投诉审查(质量和医疗) 1.3Discrepancy and failure investigations 不一致和失败的调查 1.4Document Control 文件控制 1.5Batch release 批放行 1.6Change Control变更控制 1.7Reprocess/Rework再加工/返工 1.8Returns/Salvages 退回/补救 1.9Rejects 拒收 1.10Stability Failures稳定性失败 1.11Quarantine 待验 1.12Validation: computer, equipment, process, laboratory methods, cleaning 验证：计算机、设备、工艺、实验方法、清洁 1.13Training/qualification 培训/资质 1.14internal Audit Program内审规程 1.15Supplier Audit Program 供应商审计规程 2FACILITIES AND EQUIPMENT SYSTEM 厂房设施与设备系统 IFacilities 厂房设施 2.1cleaning and maintenance 清洁与维护保养 2.2facility layout and air handling systems厂房设施布局与空气处理系 统 2.3general air handling systems 全面的空气处理系统 2.4control system for implementing changes in the building实施在厂房 方面变更的控制系统