中国原料药企业的质量审计.ppt

Inspection-Laboratory Inspection-Laboratory Standard reference Temperature well controlled and recorded; Identification clear and in-place; Material is well balanced; Warehouse control-like management Sample retention Temperature well controlled and recorded; Identification clear and in-place; Material is well balanced; Warehouse control-like management Sample keeping at least 1 year after expiration Inspection-Laboratory Inspection-Laboratorycommon problem Air exhausted from Bio-identification test is not allowed to go cycling; Some rooms are not very well equipped; balance: no anti-shock table; Room condition for balance and precise equipment, not well controlled Put animal test lab into use without local authority’s permit. Quality Assurance inspection Validation Inspection-Validation VMP Validation Master Plan Validation concept; Organization; Responsibility; IQ,OQ,PQ format or content of the protocol; IQ,OQ,PQ format or content of the report; Definition of ok or not; Validation concept Validation Concept User Requirments Specification 用户需求标准 Funcional Specification 功能标准 Technical Specification 技术标准 Realization 实现 PQ: Performance Qualification PQ：性能确认 OQ: Operational Qualification OQ：运行确认 IQ: Installation Qualification IQ：安装确认 DQ: Design Qualification + GMP-RA DQ：设计确认+GMP-RA Validation organization Group Leader Factory And Utility Equip ment Process Cleaning Method Computer 验证对象 验证进度计划 1月 2月 3月 4月 5月 6月 7月 8月 9月 10月 11月 12月 厂房设施及空调净化系统 DQ ▲ IQ ▲ ▲ OQ ▲ PQ ▲ 纯化水系统 DQ ▲ IQ ▲ OQ ▲ PQ ▲ ▲ 清洗验证 ▲ ▲ ▲ ▲ 分析仪器 ▲ 检验方法 ▲ ▲ ▲ 生产工艺 ▲ ▲ ▲ ▲ Inspection-Validation Installation Qualification Make sure the installation was done according to the producer’s installation instruction and design. Operation qualification The equipment/unit could be running at its max capacity Chinese companies are providing fake info because it is old one Inspection-Validation Performance qualification Continuous 3 batches; Production parameter uses top and low limit; Official batc