01 FDA QSR820教材00.pdfVIP

FDA QSR820 谢伟森 QSR 820历史 • 1978 FDA颁布cGMP • 1990 FDA 根据SMDA －医疗器械安全法案对 cGMP进行修改，并对cGMP讨论 • 1997 FDA发布最终规范－QSR820 质量管理 体系规范 QSR820 框架 • Subpart A--General Provisions §820.1 - Scope. §820.3 - Definitions. §820.5 - Quality system. • Subpart B--Quality System Requirements §820.20 - Management responsibility. §820.22 - Quality audit. §820.25 - Personnel. • Subpart C--Design Controls §820.30 - Design controls. • Subpart D--Document Controls §820.40 - Document controls. • Subpart E--Purchasing Controls §820.50 - Purchasing controls. • Subpart F--Identification and Traceability §820.60 - Identification. §820.65 - Traceability. • Subpart G--Production and Process Controls §820.70 - Production and process controls. §820.72 - Inspection, measuring, and test equipment. §820.75 - Process validation. • Subpart H--Acceptance Activities §820.80 - Receiving, in-process, and finished device acceptance. §820.86 - Acceptance status. • Subpart I--Nonconforming Product §820.90 - Nonconforming product. • Subpart J--Corrective and Preventive Action §820.100 - Corrective and preventive action. • Subpart K--Labeling and Packaging Control §820.120 - Device labeling. §820.130 - Device packaging. • Subpart L--Handling, Storage, Distribution, and Installation §820.140 - Handling. §820.150 - Storage. §820.160 - Distribution. §820.170 - Installation. • Subpart M--Records §820.180 - General requirements. §820.181 - Device master record. §820.184 - Device history record. §820.186 - Quality system record. §820.198 - Complaint files. • Subpart N--Servicing §820.200 - Servicing. • Subpart O--Statistical T