第五章 5. FDA工厂检查指南附件(原料药类).pdfVIP

Appendix C: Checklist 附录C ：审核列表 I: Personnel I ：人员 Measures in place to ensure control of communicable disease. 措施到位，确保控制传染性疾病。 Procedures to ensure no ill persons are in processing area. 有确保无生病的人在生产区域的程序 Required hygiene practices for all persons on duty. 要求所有当值人员按卫生规范操作 Education and training in proper food handling procedures in place. 进行食品操作程序的教育与培训 Supervisors are assigned to ensure compliance with cleanliness procedures. 指定主管进行清洁程序的确认 II: Inspection of Grounds and Sanitary Operations II ：地面和卫生操作的检查 Grounds 地面 Equipm