CGMP--中英文对照

PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING，PROCESSING，PACKING, OR HOLDING OF DRUGS；GENERAL210部分有关于生产、加工、包装和药品的储存的现行GMP;一般准则Sec. 210.1 Status of current goodmanufacturing practice regulations。

210.1 cGMP的法规地位。

(a）The regulations set forth in this part and in parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture，processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. （a）在本部分及本章第211－226部分中所陈述的法规,为现行GMP最低要求，适用于药品制造、加工、包装或贮存中所采用的方法及所使用的设施或控制手段,以保证该药品符合《联邦食品、药品及化妆品法案》（以下简称法案）对安全性的要求，具有均一性和效价（或含量)并符合或代表其生产过程的质量及纯度等特征。

Subpart A-General Provisions§211.1 Scopea)The regulations in this part contain theminimum current good manufacturing practice for preparation of drug products for administration to humans or animals.b)The current good manufacturing practiceregulations in this chapter, as they pertain to drug products, and in parts 600 through 680 of this chapter, as they pertain to biological products for human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event it is impossible to comply with applicable regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the regulation in this part.c)Pending consideration of a proposedexemption, published in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use. Therefore, until further notice, regulations under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice.§211.3 Definitions.The definitions set forth in §210.3 of this chapter apply in this part.A．总则211．1 范围（a）本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产管理规范（GMP）。

C G M P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 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 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:• Require ments 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: Holding 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• N SF/ANSI 173 Section 8.2:• Compliance with the Public Health 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 Food 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 personnel 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 conditions 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 cont rol policies • 员工必须进行疾病控制方针的书面程序与知识的培训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 code 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 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。

监控程序
VI. COMPONENTS AND CONTAINER/CLOSURES .................................................... 27
药品成分和容器 /密封 A. Components..................................................................................................................................27
法规架构 B. Technical Framework .......................................................................................................iologics Evaluation and Research Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852-1448 /cber/guidelines.htm.
辅助洁净区域 C. Clean Area Separation ................................................................................................................ 11
净化区的隔离 D. Air Filtration ................................................................................................................................ 12