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1、a,1,“GMP” Good Manufacturing Practice “GMP”:熟悉 “良好药品生产管理规范 ” Make it a habit! 养成良好的药品生产规范习惯 Help us produce QUALITY products and earn the trust of millions of people who use our products! GMP帮助我们生产出优质的产品并赢得消费者的信赖!,GMP,Notes,a,2,a,3,Keep Areas and Equipment Clean. 保持场区和设备的清洁 1. Follow approved cleani
2、ng procedures and use approved cleaning solutions. 遵照批准的清洁SOP,使用规定的清洁剂 2. Use trash cans and empty when full. 使用垃圾桶,满时清空 3. Before using equipment, make sure it has a “Clean and Ready for Use” tag. 设备使用前,确认挂有“已清洁”标识 Unclean areas and equipment can cause contamination of products! 未清洁场区和设备将对产品造成污染!,G
3、MP,Notes,a,4,Keep All Areas Clean. 保持所有区域整洁 Work Cleanly! 工作时清洁 Clean as you go!离开时清洁 Properly store and remove trash and waste materials. 时刻保持环境整洁! We All Benefit From A Clean, Safe, and More Productive Workplace! 每个人都能从一个整洁、安全、更富成效的工作场所中获益 !,GMP,Notes,a,5,Have Another Person Perform Doublechecks A
4、s Indicated In The Batch Record. 批记录需经双人复核 It is always good to have a second set of eyes confirm your results. This gives greater assurance to the accuracy of the data and the QUALITY of the product. 双人复核更能保证数据的准确性和产品质量能为产品质量提供更大的保障!,GMP,Notes,a,6,Wash your hands. 勤 洗 手 Personal cleanliness is impo
5、rtant to YOU and to the product! Make it a habit! 个人清洁卫生对于您和产品至关重要! 请养成良好的卫生习惯!,GMP,Notes,a,7,Wear Personal Protective Equipment. 请穿戴个人防护设备用品 1. Wear Your Safety Glasses. 戴好安全眼镜 2. Wear gloves when handling product. 接触产品时必须戴好手套 We care about YOUR safety and product safety! 我们关心您的安全和产品的质量!,GMP,Notes,
6、a,8,Keep Doors Closed. 请随手关门 Keep doors closed to prevent contamination and to keep temperatures and humidities stable. 随手关门,防止污染,保持温湿度稳定!,GMP,Notes,a,9,Make Sure Equipment is Calibrated Before Use. 确认仪器设备在使用前经过校验 Check calibration stickers on your equipment. Make sure that they are within the calib
7、ration date. If the calibrations are out, notify your supervisor immediately. Do not use the equipment. 检查仪器设备上的校验标签,确认在校验周期内。如果超期,立即报告主管。禁止使用超过校验有效期的仪器设备! Equipment that is not calibrated correctly may not be operating correctly! 未经正确校验的设备可能产生错误的结果!,GMP,Notes,a,10,Record Results as You Get Them. 随时
8、记录数据 1. Take the time to record results as they happen. 产生数据后立刻填写记录 2. Record results immediately on Batch Records, Cleaning Logs, etc. 及时填写批纪录和清洁记录等 Everything must be recorded at the time you get the results. Data is more accurate that way! 一旦获得数据必须及时正确记录!,GMP,Notes,a,11,Everything Must Have a Lab
9、el or a Tag. 所有物品凡事皆有标签或标识 1. If its in the facility - It MUST have a label! 工厂里的物品料都应贴上标签! 2. Do not remove or replace labels or tags. 禁止私自除去或更换标签和标识 If something is not labeled or tagged, it is impossible to know what it is! 没有标签或标识就无法知道其为何物!,GMP,Notes,a,12,Good Documentation Practices. 养成良好的文件记录习
10、惯 1. Never use pencils. Never use “white-out”. 禁止使用铅笔和涂改液 2. If you make a mistake: (1) Draw 2 line through the mistake. (2) Write in the correct information. (3) Initial and date above the line. 写错时: (1)首先在错误处划二条横线 (2)然后写上正确信息 (3)最后签名和日期,GMP,Notes,a,13,Read And Train On All SOPs ThatRelate To Your
11、Work. 阅读并掌握相关SOP You must know your SOPs- Its your responsibility. 熟悉SOP这是您的职责! Good SOPs and properly trained employees lead to a QUALITY product. 完善的SOP和受过良好培训的员工能够生产出优质的产品!,GMP,Notes,a,14,Always Fill In The Blanks. 正确填写记录 1. Record ALL requested information. 记录所有要求的信息 2. If the “Blank” is “Not Ap
12、plicable” record N/A. 不适用的空格需填写“N/A” 3. Always initial and date. 必须有签名和日期 If you dont document it It didnt happen! 没有记录等于没有发生!,GMP,Notes,a,15,a,16,QUALITY is #1. 质量第一 Take pride in performing your job! Build QUALITY into the product! 为你的良好工作表现自豪! 以生产出优质的产品为目标! Perform Your Job Right The First Time a
13、nd Every time! 自始至终正确完成工作!,GMP,Notes,a,17,Be Safe - Reduce The Hazards. 注意安全,减少危害 1. Always anticipate dangerous situations - think ahead! 提高安全意识,防患于未然! 2. Remove all loose clothing and jewelry. 禁止在生产作业过程中佩戴首饰 We care about YOUR safety! 您的安全是我们的牵挂!,GMP,Notes,a,18,Read and Observe All Labels and Signs. 遵守标签和告示牌内容 1. Read all labels and signs carefully 认真阅读标签和
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