9. Personnel 人员 General 概述 Key personnel 关键人员 10. Training 培训 11. Personal hygiene 人员卫生 12. Premises 厂房 General 概述 Ancillary areas 辅助区域 Storage areas 仓储区域 Weighing areas 称量区域 Production areas 生产区域 Quality control areas QC区域 13. Equipment 设备 14. Materials 物料 ...
aThe Management Personnel report to and work under the supervision and direction of the Board. The Management Personnel consist of a chief executive officer (“CEO”) (who shall also serve as the General Manager and a director of the Board of the Company), a chief operation officer (“COO”...
action 后续措施 Quality audit 质量审计 Suppliers’ audits and approval 供应商审计和批准 9. Personnel 人员 General 概述 Key personnel 关键人员 10. Training 培训 11. Personal hygiene 人员卫生 12. Premises 厂房 General 概述 Ancillary areas 辅助区域 Storage areas 仓储区域 Weighing areas 称量区域 ...
—keypersonnelandtheirresponsibilities;关键人员及其职责 —aparallelcomparisonofmaterials,methodsandequipment;原料、方法和设备的平行比较 — accomplishedbeforethenextcommences;转移各步骤均应有书面证据证明每个关键步骤圆满 完成后,方可进入下一步骤 —identificationofcriticalcontrolpoints;关键控制点的识别 ...
personnelqualification and training; 人员资质与培训; qualitymanagement and risk management; 质量管理和风险管理; lifecycle approach; 生命周期方法; controlstrategy; and 控制策略;以及 qualificationand validation. 确认与验证。 3.Glossary 术语 Thedefinitions given below apply to the terms used in these guid...
• an adequate number of adequately trained personnel with suitable qualifications and experience; and •有足够的经过适当培训的人员,具有适当资质和经验; • effective process and product knowledge management. •有效的工艺和产品知识管理。 1.6 A technology transfer should include rel...
d)Sitenumber(e.g.sitemasterfileornumberallocatedbytheresponsibleauthority).场所的编号（例如：被责任部门分配的场所主文件或编号）(e)Manufacturinglicencenumber,ifapplicable.生产许可证的编号(f)Activities.生产(g)Pharmaceuticalproductsmanufactured.被生产的药品名称(h)Keypersonnel.关键人员(i)Keypersonsmet.与之接触...
• personnel qualification and training; •人员资质和培训; • quality management and risk management; •质量管理和风险管理; •life cycle approach; •生命周期方法; • control strategy; and •控制策略; • qualification and va...
The company he serves is a subordinate unit of the government department, and he has been here for ten years after graduation. At first, it was the most basic technical personnel, eager to learn, considerate and low-key, so colleagues liked leadership appreciation. ...
•anadequatenumberofadequatelytrainedpersonnelwith suitablequalificationsandexperience;and •有足够的经过适当培训的人员,具有适当资质和经验; •effectiveprocessandproductknowledgemanagement. •有效的工艺和产品知识管理。 1.6Atechnologytransfershouldincluderelevant documentation,data,informationandknowledgefromtheSUin...