CGMP中英文对照.docx

1、CGMP中英文对照CGMP中英文对照Table of Contents 目录 SUBPART B 111.10 111.14: Personnel 人员 SUBPART C 111.15 111.23: Physical Plant and Grounds 工厂与场所 SUBPART D 111.25 111.35: Equipment and Utensils 设备与器具 SUBPART E 111.55-111.95: Production and Process Control System 生产与过程控制系统 SUBPART F 111.103-111.140: Production

2、and Process Control System: Requirements for Quality Control 生产与过程控制系统对质量控制的要求 SUBPART G 111.153 111.180: Production and Process Control System: Requirements for components, packaging, and labels 生产与过程控制系统对成分，包装与标签的要求 SUBPART H 111.205-111.210: Production and Process Control System: Requirements for

3、 the Master Manufacturing Record. 生产与过程控制系统对主要制造记录的要求 SUBPART I 111.255 111.260: Production and Process Control System: Requirements for the Batch Production Record. 生产与过程控制系统对批生产记录的要求 SUBPART J 111.303 111.325: Production and Process Control System: Requirements for Laboratory Operations 生产与过程控制系统对

4、实验室操作的要求 SUBPART K 111.353 111.365: Production and Process Control System Requirements for Manufacturing Operations 生产与过程控制系统对制造过程的要求 SUBPART L 111.403 111.425: Production and process control system Requirements for Packaging and Labels Operation 生产与过程控制系统对包装与标签操作的要求 SUBPART M 111.453 111.475: Holdi

5、ng and Distributing 扣留与分发 SUBPART N 111.503 111.535: Return of Dietary Supplements 膳食补充剂的退货 SUBPART O 111.553 111.570: Product Complaints 产品投诉 SUBPART P 111.605 111.610: Records and Recordkeeping 记录与记录保留 11.10 11.50: Electronic Records 电子记录 NSF/ANSI 173 Section 8.2: Compliance with the Public Health

6、 Security and Bioterrorism 符合公共健康安全与生物反恐 NSF/ANSI 173 Section 8.3: Adverse Event Reporting 不利事件的报告 NSF/ANSI 173 Section 8.4: Recall Procedures 回收程序 Appendix 1 NSF 229 Functional Food Guideline 功能性食品导则 Appendix 2 NSF 306 GMP for Sport 运动食品的GMP要求 Appendix 3 NSF 306 GMP for Sport & NSF 229 Functional F

7、ood Guideline 运动食品与功能性食品的GMP要求 PERSONNEL B人员Question 1 CFR 111.10Procedures have been established that define work requirements for personnel to prevent microbial contamination from illnesshygienic practices.建立员工工作要求的程序以预防疾病的微生物污染 a. A written procedure shall exist and be current stating that person

8、nel with medical conditions such as open lesions or infected 规定员工身体状况如开放性伤害或感染的书面程序必须存在并且为当前的 wounds will be removed from the manufacturing process so as to prevent product adulteration during manufacturing or storage. 在制造或存储时有伤口的员工远离制造流程，以避免产品被掺杂 The procedure shall state that such health condition

9、s will be reported to supervision. 必须建立上述身体情况向主管汇报的程序，以便于监管 b. Inspection verifies that such workers are not in areas where adulteration could occur. 有检查的验证表明上述的员工不在掺杂可能发生的区域 c. Personnel shall be trained on the written procedure and knowledgeable of the disease control policies 员工必须进行疾病控制方针的书面程序与知识

10、的培训Question 2 CFR 111.10Hygienic practices have been established to include appropriate garments, personal hygiene, hand washing and sanitization, etc. prior to starting work and at any time whereby personnel can become soiled/contaminated.在工作前或员工被污染时需要建立包括适当的服装，员工卫生，洗手与消毒等的卫生操作 a. A written dress c

11、ode shall exist and be current stating appropriate attire for workers, supervisors, managers and visitors to all parts of the production, storage, packaging and testing facilities.表明员工，主管，经理，参观者进入生产，储存，包装与测试区域穿着适当服装的书面服装规则必须存在且为当前的 b. Outer garments shall be donned prior to entering the facility and

12、 shall not be worn outside the production facility or home. Therefore proper changing areas are required. Outer garments shall have long sleeves and have secured fasteners. Above waist pockets (or carrying items in pockets) should be avoided.进入工厂前必须穿工作衣，并且不能在生产工厂外面或家里穿工作衣。也需要有适当的更衣区域，工作衣需要有长袖子与安全的纽扣

13、。避免有在腰部以上的口袋或口袋内存放的物品。 c. Outer garments shall not be worn into restroom and appropriate hooks should be provided. 不能在厕所内穿工作衣，需要有适当的挂钩。 d. A written procedure shall exist and be current describing hand washing requirements including methods and frequencies. The procedure shall also cover glove use a

14、nd hand sanitizers if used.包括洗手方法与频率的洗手程序必须存在且为当前的，如果需要该程序应包含戴手套与使用消毒液。Question 3 CFR 111.10Procedures for removal of jewelry and other items or appropriate coverings.不能戴首饰与其他物品或适当遮盖物的程序 A written procedure shall exist and be current describing wearing of jewelry. Jewelry if allowed must be secured

15、to prevent product adulteration. Hand jewelry must be covered if it cannot be removed. 戴首饰的书面程序必须存在且为当前的。如果允许戴首饰，则必须保证是安全的以预防产品掺杂。手上的饰 品如果不能去除，则必须覆盖保护。Question 4 CFR 111.10Procedures for use of impermeable gloves, hairnets, caps, beard covers, etc. and for restrictions on use of food, drinks, tobacc

16、o, etc. in areas whereby product contamination could occur. Procedures have been established to prevent contamination from all extraneous sources. 在产品可能受到污染的区域，需要制定使用非渗透性的手套，发网，帽子，须套以及限制饮食，喝水，吸烟等的程序。需要 建立预防所有外来物质污染的程序。 a. A written procedure shall exist and be current excluding the use of tobacco pr

17、oducts, on sumption of food, gum, drink or medicine from production areas. 在生产区域不能使用香烟，饮食，口香糖，饮料与药品的书面程序必须存在并且为当前的 b. A written procedure shall exist and be current describing what types of items cannot be taken into production areas including personal effects or clothing. The procedure should cover

18、 the prevention of personal care products from entering product. 包括描述个人财物与衣服等条款类型不能带入生产区域的书面程序必须存在并且为当前的。该程序包含预防 个人喜欢的产品混入产品。Question 5 CFR 111.10Appropriate change rooms are available if needed and there is adequate storage of personal effects.如果需要，应当提供适当的更衣室，更衣室能足够储存个人物品。 a. Change rooms if needed

19、 are orderly and clean. Procedures cover cleaning change rooms. 所需的更衣室应当整洁与干净，有清洁更衣室的程序。 b. Training has occurred for all the above policies 对以上所有方针进行培训Question 6 CFR 111.12Personnel must be qualified and have adequate training, experience and/or education necessary to perform job functions.员工必须有资格，

20、有足够的培训，经历与教育以完成工作 All personnel shall have written job descriptions, which include job requirements and reporting structure. Job descriptions should follow good documentation practices including revision control and appropriate sign offs.所有员工必须有包括工作要求与汇告结构的书面的工作描述。工作描述应当遵守包括修改与结束的良好文件规范。 b. All pers

21、onnel including management shall receive annual GMP training and education to perform their assigned functions. 包括管理者的所有员工每年接受GMP的培训与教育以完成指定的工作 c. Training comprehension for annual GMP training is required. Comprehension can be shown by routine questioning of employees to determine understanding of

22、GMPs as they relate to their job function.需要有年度GMP培训的理解。培训的理解可以以员工日常询问的方式进行以确定员工明白了与他们工作职责有关的GMP要求。 d. Temporary workers shall receive documented basic GMP training prior to beginning work. 临时工在上岗前必须有书面的基本GMP的培训Question 7 CFR 111.12Quality responsibilities are distinct and separate from operations.质

23、量职责是清楚的并与生产分开的 a. A clear organization chart shall be available that is current and up to date. 有最近的明确的组织结构图 b. Quality control department/personnel shall exist and duties shall be documented (specific duties listed in Subpart F). The Quality Manager shall not report directly to the Production Manag

24、er to ensure that quality decisions can be made independent of production decisions. Consideration will be given for small plants where individuals have multiple organizational responsibilities 质量控制部门与人员必须存在，其职责必须书面化（特定的职责在F部分）。质量经理不能直接向生产经理 汇报，以保证质量的决定与生产的决定是独立的。个人有多个组织职责的小工厂可以体谅。Question 8 CFR 111

25、.13Procedures have been established to define the requirements for personnel who will supervise activities.建立执行管理活动的人员明确要求的程序 a. Supervisors shall have written job descriptions, which include job requirements and reporting structure. Job descriptions should follow good documentation practices includ

26、ing revision control and appropriate sign offs.主管有包括工作要求与汇告结构的书面的工作描述，工作描述应当遵守包括修改与结束的良好文件规范。 b. Assure each department has designated and qualified supervisors. 确保每个部门有指定的并有资质的主管 c. Procedures for supervisors, managers, and other levels of supervision and responsibility exist. The procedures should

27、 outlinethe requirements to be in a supervisory position and also periodic assessment and procedures to remove a person from supervisory responsibilities if they do not sustain the qualification主管，经理与管理的其他等级的程序与职责应当存在。该程序应当列出管理职位的要求，并定期评估；如果不能胜任，应当调离管理职位。Question 9 CFR 111.13Personnel who are design

28、ated as supervisors are qualified and have written requirements.主管人员有资格并有书面的要求 a. If multiple shifts of operation are used, designated trained supervisors are required 如果有多个班次的生产，需要有指定的培训的主管。Question 10 CFR 111.14Procedures have been established and records are maintained documenting compliance to t

29、hese procedures.应当建立程序，并且有记录表明符合这些程序 a. A written procedure shall exist and be current outlining the training policy and program. The procedure shall include how training is conducted for new hires, annual training for all personnel and contractor training if applicable. The training program should

30、include training topics and frequencies as well as forms for documenting training. 培训方针与计划的书面程序必须存在且为当前的。该程序必须包含新员工怎样培训，所有员工或适用的承包者的年度培训。培训计划应当包含培训主题与频率，有培训的记录。 b. Training and procedures shall be available in appropriate languages. 用适当的语言进行培训与书写程序。 c. Training documentation shall include a roster o

31、f who attended, date of training, subject matter taught and the name of the trainer. 培训记录应当包含培训人的名单，培训日期，培训主题与培训老师。Question 11 CFR 111.12Job descriptions are available for all personnel and personnel have received GMP and appropriate training for their assigned functions.所有员工以及有接受GMP与工作职责培训员工应当有工作描述 a. All personnel shall have written job descriptions, which include job requirements and reporting structure Job descriptions should follow good documentation practices including revision control and appropriate sign offs.所有员工必须有包括工作要求与汇告结构的书面的工作描述。工作描述应当遵守包括修改与结束的良好文件规范。 b. All personnel inclu