1. 各车间对比统一及维持Unity and maintenance of comparisons among workshops2. FDA官方审计准备FDA Official Audit Preparation3. 车间现场定期检查Workshop site periodic inspection4. 各车间风评的新建，升版与统一New build, update and unification of risk assessment in each workshop5. 质量事件偏差发起，偏差变更的审核，CAPA或action item的定期追踪Initiation of deviation for quality events, review of deviation and change control, and regular tracking of CAPA or action item6. 审计前车间检查、审计回复审核、客户参观Pre-audit workshop inspection, audit response review, visit7. 法规指南、FDA483、官方审计或其他基地审计发现项GAP分析及分享GAP Analysis and Sharing of Regulatory Guidance, FDA 483, Official Audit or Other Site Audit Findings8. 样品运输验证，SOP的新建并维护Sample Shipment Verification, SOP Create and Maintain9. 新车间流程建设：放行前SOP等文件的管理，审核及追踪Process construction of new workshop: Management, review and tracking of SOP before facilityrelease11. 公用SOP管理：general SOP的维护Common SOP management: maintenance of general SOP 12. 领导交代的其他事务Other matters addressed by the leader