生产过程质量控制点监测管理制度（Monitoring and management system of quality control points in production process）.docVIP

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生产过程质量控制点监测管理制度（Monitoring and management system of quality control points in production process）.doc

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生产过程质量控制点监测管理制度（Monitoring and management system of quality control points in production process）

生产过程质量控制点监测管理制度（Monitoring and management system of quality control points in production process） Monitoring and management system of quality control points in production process 2007-6-16 0:00:00 China 114 network browsing: 2001 veterinary drug trade Company GMP management documents Subject Monitoring and management system of quality control points in production process Code： SMP-SC-0160-00 A total of 7 pages Formulate To examine Approval Date set Audit date Approval date Issuing department Office Quantity issued effective date Distribution unit Office, production technology department, quality department, material supply department, Engineering Department I. Objective: to formulate the monitoring and management system for important quality control points in the production process, so as to ensure the strict control of the quality of the products in each production link. Two. Scope of application: it is applicable to quality control in the production process of production technology department. Three 、 responsibility: production technology manager, QA inspector. Four, text: In order to ensure the quality of the products, the quality of the production process must be monitored and controlled, and the quality control points of the production process and the supervision and management system are as follows: 1 final sterile small volume injection 2.1 purified water, water for injection: clarity must meet the standards 2.2 ampoule washing and drying sterilization: in the ready room off the packaging into the rough rough wash wash room, wash room evacuation into washing wall should be rinsed with purified water, the inner wall of at least two times, finally rinse with water after injection of 0.45 m membrane filtration qualified clarity, drying, sterilizing, cooling, ampoule after sterilization should be used immediately or stored clean storage shall not exceed 2 days, after washing bottles should be clean and clarity check. 1.3 weighing: before weighing, should check th