麻花精品

颁濒辞谤辞虫高乐氏验厂中英文文件清单

1. Organizational Chart 组织架构图

2. Manufacturing Process Flow Chart/Summary生产工艺流程图

3.       Certificate of Analysis化验证明书

4.       Certificate of Origin原料原产地证书

5.       Technical Data Sheet/Product Specification Sheet技术资料表/产物规格书

6.       Quality Manual质量手册

7. SOP Table of Contents标准作业程序

8. Lot Traceability Procedure各种追溯程序

9.       Change Control Procedure(s)变更程序

10.   Customer Complaint Procedure(s)客户投诉程序

11.   Nonconformance/Out-of-Specification Procedure(s)不合格产物处理程序

12.   Corrective Action/Preventive Action (CAPA) Procedure纠正/预防措施

13.   Management Responsibility / Quality Policy管理职责/质量方针

14.   Documentation Program Procedure(s) 文档程序

15.   Training Program Procedure(s) 培训方案

16.   Hold Release Program Procedure(s) 保留放行程序(针对未检验/不合格原料或部件)

17.   Process Control/Capability Procedure(s)过程控制程序

18.   Testing Procedure(s) for Material and Finished Goods材料和成品检验程序

19.   Label Control Procedure(s)标签控制程序

20.   Recall and Mock Recall Program Procedure(s)召回和模拟召回程序

21.   Supplier Qualification Program Procedure(s)供应商资格程序

22.   Equipment Preventive Maintenance and Calibration Program Procedure(s)设备预防性维护和校准性程序

23.   Validation Program Procedure(s)验证程度

24.   Audit Program Procedure(s)审计程序

25.   Stability Program Procedure稳定性程序

26.   Facilities Foreign Matter, Adulteration Prevention Program Procedure(s)

(Pest Control, Housekeeping, Environmental Monitoring, etc.)设施杂质,防止掺假程序(如防治虫鼠,内务管理,环境监察等)

27.  Technology Transfer Procedure(s)技术转让程序

28.   Drug/Device Master Record药品/器械记录

29.   Product Device History Record产物设备历史记录