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Good Manufacturing Practices for Veterinary Drugs (2020 Revision) [Effective]
兽药生产质量管理规范(2020年修订) [现行有效]
【法宝引证码】

Order of the Ministry of Agriculture and Rural Affairs of the People's Republic of China 

中华人民共和国农业农村部令

(No. 3 [2020]) (2020年第3号)

The Good Manufacturing Practices for Veterinary Drugs (2020 Revision), as deliberated and adopted at the 6th executive meeting of the Ministry of Agriculture and Rural Affairs on April 2, 2020, are hereby issued and shall come into force on June 1, 2020. 兽药生产质量管理规范(2020年修订)》已经农业农村部2020年4月2日第6次常务会议审议通过,现予公布,自2020年6月1日起施行。
Minister: Han Changfu 部长 韩长赋
April 21, 2020 2020年4月21日
Annex: Good Manufacturing Practices for Veterinary Drugs (2020 Revision) 附件:兽药生产质量管理规范(2020年修订)
Good Manufacturing Practices for Veterinary Drugs (2020 Revision) 兽药生产质量管理规范(2020年修订)
Chapter I General Provisions 

第一章 总  则

Article 1 For the purpose of strengthening the production and quality management of veterinary drugs, the Good Manufacturing Practices for Veterinary Drugs (“GMP for Veterinary Drugs”) are formulated in accordance with the Regulation on the Administration of Veterinary Drugs.   第一条 为加强兽药生产质量管理,根据《兽药管理条例》,制定兽药生产质量管理规范(兽药GMP)。
Article 2 The GMP serve as the basic requirements for the production management and quality control of veterinary drugs, with the aim to ensure the continuous and stable production of veterinary drugs which comply with the requirements of the marketing authorization.   第二条 本规范是兽药生产管理和质量控制的基本要求,旨在确保持续稳定地生产出符合注册要求的兽药。
Article 3 An enterprise shall strictly implement the GMP, adhere to honesty and good faith, and prohibit any falsehood or fraud.   第三条 企业应当严格执行本规范,坚持诚实守信,禁止任何虚假、欺骗行为。
Chapter II Quality Management 

第二章 质量管理

Section 1 Principle 

第一节 原则

Article 4 An enterprise shall set the quality objectives meeting the requirements for the quality management of veterinary drugs, systematically implement all requirements for the safety, effectiveness and quality control of veterinary drugs during the whole process of production, control, product release, storage and sale of veterinary drugs, so as to ensure that the manufactured products comply with the registration requirements.   第四条 企业应当建立符合兽药质量管理要求的质量目标,将兽药有关安全、有效和质量可控的所有要求,系统地贯彻到兽药生产、控制及产品放行、贮存、销售的全过程中,确保所生产的兽药符合注册要求。
Article 5 The attainment of the predetermined quality objectives is the responsibility of senior management and requires the participation and commitment of staff at all levels within the enterprise.   第五条 企业高层管理人员应当确保实现既定的质量目标,不同层次的人员应当共同参与并承担各自的责任。
Article 6 An enterprise shall be adequately resourced with competent personnel, premises, facilities and equipment to provide necessary conditions for the attainment of the quality objectives.   第六条 企业配备的人员、厂房、设施和设备等条件,应当满足质量目标的需要。
Section 2 Quality Assurance 

第二节 质量保证

Article 7 An enterprise must establish a quality assurance system and a complete system of documentation, so as to ensure the effective operation of the quality assurance system.   第七条 企业应当建立质量保证系统,同时建立完整的文件体系,以保证系统有效运行。
An enterprise shall establish an information management system for key production processes of high-risk products in order to record and monitor them online. 企业应当对高风险产品的关键生产环节建立信息化管理系统,进行在线记录和监控。
Article 8 A quality assurance system shall ensure that:   第八条 质量保证系统应当确保:
1. veterinary drugs are designed and developed in a way that takes account of the requirements of the GMP; (一)兽药的设计与研发体现本规范的要求;
2. production management and quality control operations comply with the requirements of the GMP; (二)生产管理和质量控制活动符合本规范的要求;
3. managerial responsibilities are clearly specified; (三)管理职责明确;
4. arrangements are made for the purchase and use of the correct starting and packaging materials; (四)采购和使用的原辅料和包装材料符合要求;
5. intermediate products are subject to effective control; (五)中间产品得到有效控制;
6. qualification and validation activities are carried out; (六)确认、验证的实施;
7. the products are produced, checked, tested and verified in strict accordance with the defined procedures; (七)严格按照规程进行生产、检查、检验和复核;
8. each batch of products are released only upon the approval of the head of quality management; (八)每批产品经质量管理负责人批准后方可放行;
9. satisfactory arrangements exist to ensure that the veterinary drugs are stored, sold, and subsequently handled in the way that quality is maintained; and (九)在贮存、销售和随后的各种操作过程中有保证兽药质量的适当措施;
10. the effectiveness and applicability of the quality assurance system are regularly inspected and assessed according to the procedure for self inspection. (十)按照自检规程,定期检查评估质量保证系统的有效性和适用性。
Article 9 The basic requirements for the good manufacturing practices of veterinary drugs are that:   第九条 兽药生产质量管理的基本要求:
1. all manufacturing processes are defined, systematically reviewed, and shown to be capable of consistently and steadily manufacturing veterinary drugs of the required quality; (一)制定生产工艺,系统地回顾并证明其可持续稳定地生产出符合要求的产品。
2. manufacturing processes and significant changes to the processes are validated; (二)生产工艺及影响产品质量的工艺变更均须经过验证。
3. necessary resources are provided, at least including: (三)配备所需的资源,至少包括:
(1) appropriately qualified and trained personnel; 1.具有相应能力并经培训合格的人员;
(2) adequate premises and space; 2.足够的厂房和空间;
(3) suitable facilities, equipment and maintenance services; 3.适用的设施、设备和维修保障;
(4) correct starting materials, packaging materials and labels; 4.正确的原辅料、包装材料和标签;
(5) approved master formula and procedures; and 5.经批准的工艺规程和操作规程;
(6) suitable storage and transport. 6.适当的贮运条件。
4. procedures are written in clear and unambiguous language; (四)应当使用准确、易懂的语言制定操作规程。
5. operators are trained and can carry out procedures correctly; (五)操作人员经过培训,能够按照操作规程正确操作。
6. records are made during the whole manufacturing process and all deviations are fully investigated and recorded; (六)生产全过程应当有记录,偏差均经过调查并记录。
7. batch records, sales records and electronic traceability code information, which enable the complete history of a batch to be traced, are retained in a proper and accessible form; (七)批记录、销售记录和电子追溯码信息应当能够追溯批产品的完整历史,并妥善保存、便于查阅。
8. appropriate measures are taken to minimize any risk to the quality of veterinary drugs during their sale; (八)采取适当的措施,降低兽药销售过程中的质量风险。
9. a system for recall of veterinary drugs is available to recall any batch of products from sale; and (九)建立兽药召回系统,确保能够召回已销售的产品。
10. complaints about veterinary drugs are examined, the causes of quality defects investigated, and measures taken in respect of the complaints and defective products to prevent recurrence. (十)调查导致兽药投诉和质量缺陷的原因,并采取措施,防止类似投诉和质量缺陷再次发生。
Section 3 Quality Control 

第三节 质量控制

Article 10 Quality control involves the relevant organization, documentation system, sampling, testing, etc., which ensures that necessary tests are actually carried out before the release of materials or products, until their quality has been judged to be satisfactory.   第十条 质量控制包括相应的组织机构、文件系统以及取样、检验等,确保物料或产品在放行前完成必要的检验,确认其质量符合要求。
Article 11 The basic requirements for quality control are that:   第十一条 质量控制的基本要求:
1. appropriate facilities, equipment and apparatuses must be equipped and trained personnel must be staffed to ensure that all the quality control arrangements are effectively and reliably carried out; (一)应当配备适当的设施、设备、仪器和经过培训的人员,有效、可靠地完成所有质量控制的相关活动;
2. approved procedures must be available for sampling, inspecting, and testing starting materials, packaging materials, and intermediate and finished products, and for product stability studies, and where appropriate, for monitoring environmental conditions for GMP purposes; (二)应当有批准的操作规程,用于原辅料、包装材料、中间产品和成品的取样、检查、检验以及产品的稳定性考察,必要时进行环境监测,以确保符合本规范的要求;
3. samples of starting materials, packaging materials, and intermediate and finished products must be taken by the authorized personnel according to the prescribed methods; (三)由经授权的人员按照规定的方法对原辅料、包装材料、中间产品和成品取样;
4. test methods must be validated or qualified; (四)检验方法应当经过验证或确认;
5. the materials and intermediate and finished products must be inspected and tested against quality standards; (五)应当按照质量标准对物料、中间产品和成品进行检查和检验;
6. records must be made in sampling, inspection and testing and any deviations must be fully recorded and investigated; and (六)取样、检查、检验应当有记录,偏差应当经过调查并记录;
7. sufficient reference samples of materials and final products must be retained to permit future inspection or testing of the products; the retained samples of final products must be kept in their final packs unless the packs are exceptionally large. Finished products with exceptionally large final packs shall be packed for market sale in a simulated manner, with the same material and structure. (七)物料和成品应当有足够的留样,以备必要的检查或检验;除最终包装容器过大的成品外,成品的留样包装应当与最终包装相同。最终包装容器过大的成品应使用材质和结构一样的市售模拟包装。
Section 4 Quality Risk Management 

第四节 质量风险管理

Article 12 Quality risk management is a systematic process incorporating the recognition, assessment, control, communication and examination of quality risks in a forward-looking or retrospective manner during the whole life cycle of products.   第十二条 质量风险管理是在整个产品生命周期中采用前瞻或回顾的方式,对质量风险进行识别、评估、控制、沟通、审核的系统过程。
Article 13 Quality risks shall be assessed based on scientific knowledge and experiences so as to guarantee the required quality of products.   第十三条 应当根据科学知识及经验对质量风险进行评估,以保证产品质量。
Article 14 The methods or measures taken, the formality thereof and the documents prepared during the process of quality risk management shall be commensurate with the degree of existing risks.   第十四条 质量风险管理过程所采用的方法、措施、形式及形成的文件应当与存在风险的级别相适应。
Chapter III Organization and Personnel 

第三章 机构与人员

Section 1 Principles 

第一节 原则

Article 15 An enterprise shall establish a management department appropriate for its production of veterinary drugs, and have an organization chart.   第十五条 企业应当建立与兽药生产相适应的管理机构,并有组织机构图。
An enterprise shall establish an independent quality management department to perform the functions of quality assurance and quality control. The quality management department may set up a separate quality assurance department and quality control department. 企业应当设立独立的质量管理部门,履行质量保证和质量控制的职责。质量管理部门可以分别设立质量保证部门和质量控制部门。
Article 16 A quality management department shall participate in all activities relating to quality and be responsible for examining all documents relating to the GMP. No person of the quality management department shall delegate his functions to a person of any other department.   第十六条 质量管理部门应当参与所有与质量有关的活动,负责审核所有与本规范有关的文件。质量管理部门人员不得将职责委托给其他部门的人员。
Article 17 An enterprise shall have an adequate number of managers and operators with the necessary qualifications (including degree, training and practical experience), and specify the functions of each department and post. There shall be no gaps or unexplained overlaps with regard to the functions of posts. The responsibilities placed on any one individual shall not be too extensive.   第十七条 企业应当配备足够数量并具有相应能力(含学历、培训和实践经验)的管理和操作人员,应当明确规定每个部门和每个岗位的职责。岗位职责不得遗漏,交叉的职责应当有明确规定。每个人承担的职责不得过多。
All personnel shall have a clear understanding of their functions, know well the requirements that affect them, and receive necessary training, including pre-job training and continuing training. 所有人员应当明确并理解自己的职责,熟悉与其职责相关的要求,并接受必要的培训,包括上岗前培训和继续培训。
Article 18 No person shall delegate his functions to any other person, and if it is necessary, their functions may be delegated to designated persons of a satisfactory qualification level.   第十八条 职责通常不得委托给他人。确需委托的,其职责应委托给具有相当资质的指定人员。
Section 2 Key Personnel 

第二节 关键人员

Article 19 Key personnel shall be full-time personnel of the enterprise, which shall at least include the person in charge of the enterprise, the head of production, and the head of quality management.   第十九条 关键人员应当为企业的全职人员,至少包括企业负责人、生产管理负责人和质量管理负责人。
The head of quality management and the head of production shall not be the same person. There shall be procedures to ensure the independent fulfillment of functions of the head of quality management, and prevent him from disturbance by the person in charge of the enterprise and other personnel. 质量管理负责人和生产管理负责人不得互相兼任。企业应当制定操作规程确保质量管理负责人独立履行职责,不受企业负责人和其他人员的干扰。
Article 20 The person in charge of the enterprise is the principal person responsible for the quality of veterinary drugs, and takes overall responsibility for the daily management of the enterprise. To ensure the attainment of the quality objectives and the production of veterinary drugs under the GMP, the person in charge of the enterprise shall be responsible for providing necessary resources, and conduct reasonable planning, organization and coordination so as to ensure the independent performance of functions by the quality management department.   第二十条 企业负责人是兽药质量的主要责任人,全面负责企业日常管理。为确保企业实现质量目标并按照本规范要求生产兽药,企业负责人负责提供并合理计划、组织和协调必要的资源,保证质量管理部门独立履行其职责。
Article 21 Head of Production   第二十一条 生产管理负责人
1. Qualification: (一)资质:
The head of production shall at least have a bachelor's degree in pharmacy, veterinary medicine, biology, chemistry or the relevant specialty (or intermediate professional technical title), have a three-year or more experience in the manufacture and quality management of veterinary drugs, including an experience of one year or more in the production management of veterinary drugs (or drugs), and have received training on the professional knowledge relating to the products manufactured. 生产管理负责人应当至少具有药学、兽医学、生物学、化学等相关专业本科学历(中级专业技术职称),具有至少三年从事兽药(药品)生产或质量管理的实践经验,其中至少有一年的兽药(药品)生产管理经验,接受过与所生产产品相关的专业知识培训。
2. Major functions: (二)主要职责:
(1) to ensure that veterinary drugs are manufactured and stored according to the approved master formula in order to obtain the required quality; 1.确保兽药按照批准的工艺规程生产、贮存,以保证兽药质量;
(2) to ensure that all kinds of procedures relating to production operations are strictly implemented; 2.确保严格执行与生产操作相关的各种操作规程;
(3) to ensure that the batch processing records and batch packaging records are examined by a designated person and submitted to the quality management department; 3.确保批生产记录和批包装记录已经指定人员审核并送交质量管理部门;
(4) to ensure the maintenance of premises and equipment so as to keep them in sound operation; 4.确保厂房和设备的维护保养,以保持其良好的运行状态;
(5) to ensure that all necessary validations are done; and 5.确保完成各种必要的验证工作;
(6) to ensure that the required pre-job and continuing trainings of production personnel are carried out and the training contents are adjusted according to the actual need. 6.确保生产相关人员经过必要的上岗前培训和继续培训,并根据实际需要调整培训内容。
Article 22 Head of Quality Management   第二十二条 质量管理负责人
1. Qualification: (一)资质:
The head of quality management shall at least have a bachelor's degree in pharmacy, veterinary medicine, biology, chemistry or the relevant specialty (or intermediate professional technical title), have a five-year or more experience in the manufacture and quality management of veterinary drugs, including an experience of one year or more in the quality management of veterinary drugs, and have received training on the professional knowledge relating to the products manufactured. 质量管理负责人应当至少具有药学、兽医学、生物学、化学等相关专业本科学历(中级专业技术职称),具有至少五年从事兽药 (药品)生产或质量管理的实践经验,其中至少一年的兽药(药品)质量管理经验,接受过与所生产产品相关的专业知识培训。
2. Major functions: (二)主要职责:
(1) to ensure that the starting materials, packaging materials, and intermediate and finished products comply with the master formula; 1.确保原辅料、包装材料、中间产品和成品符合工艺规程的要求和质量标准;
(2) to ensure that the examination of batch records is carried out before the products are released; 2.确保在产品放行前完成对批记录的审核;
(3) to ensure that all necessary testing is carried out; 3.确保完成所有必要的检验;
(4) to approve quality standards, sampling methods, test methods and other quality management procedures; 4.批准质量标准、取样方法、检验方法和其他质量管理的操作规程;
(5) to examine and approve all changes relating to the quality; 5.审核和批准所有与质量有关的变更;
(6) to ensure that all major deviations and test results beyond limits have been investigated and handled in a timely manner; 6.确保所有重大偏差和检验结果超标已经过调查并得到及时处理;
(7) to monitor the maintenance of premises and equipment so as to keep them in sound operation; 7.监督厂房和设备的维护,以保持其良好的运行状态;
(8) to ensure that all necessary qualifications or validations are carried out, and to examine and approve the qualification or validation plans and reports; 8.确保完成各种必要的确认或验证工作,审核和批准确认或验证方案和报告;
(9) to ensure that the self inspection is completed; 9.确保完成自检;
(10) to assess and approve material suppliers; 10.评估和批准物料供应商;
(11) to ensure that all complaints relating to product quality have been investigated and handled in a timely and accurate manner; 11.确保所有与产品质量有关的投诉已经过调查,并得到及时、正确的处理;
(12) to ensure that product continuous stability studies are conducted and the data on stability studies are provided; 12.确保完成产品的持续稳定性考察计划,提供稳定性考察的数据;
(13) to ensure that the product quality review is carried out; and 13.确保完成产品质量回顾分析;
(14) to ensure that the required pre-job and continuing trainings of quality control and quality assurance personnel are carried out and traning contents are adjusted according to the actual need. 14.确保质量控制和质量保证人员都已经过必要的上岗前培训和继续培训,并根据实际需要调整培训内容。
Section 3 Training 

第三节 培训

Article 23 An enterprise shall designate a department or person to be responsible for training management, make training programs or plans examined or approved by the head of production or the head of quality management, and the training records shall be kept.   第二十三条 企业应当指定部门或专人负责培训管理工作,应当有批准的培训方案或计划,培训记录应当予以保存。
Article 24 All personnel relating to production and quality of veterinary drugs shall receive training appropriate to the duties assigned to them. Besides the training on the theory and practice of the GMP, the training on the relevant laws and regulations, functions and skills for the corresponding posts shall be given, and its practical effectiveness shall be periodically assessed. Testing personnel may hold positions after they pass the testing competency examinations.   第二十四条 与兽药生产、质量有关的所有人员都应当经过培训,培训的内容应当与岗位的要求相适应。除进行本规范理论和实践的培训外,还应当有相关法规、相应岗位的职责、技能的培训,并定期评估培训实际效果。应对检验人员进行检验能力考核,合格后上岗。
Article 25 Personnel working in areas with hazards (e.g. production areas where highly active, toxic, infectious or sensitizing materials are handled) shall be given a specific training.   第二十五条 高风险操作区(如高活性、高毒性、传染性、高致敏性物料的生产区)的工作人员应当接受专门的专业知识和安全防护要求的培训。
Section 4 Personnel Hygiene 

第四节 人员卫生

Article 26 An enterprise shall prepare procedures for hygiene of personnel so as to minimize the risk of product contamination by personnel.   第二十六条 企业应当建立人员卫生操作规程,最大限度地降低人员对兽药生产造成污染的风险。
Article 27 Personnel hygiene procedures shall include the contents relating to health and hygiene practices and the clothing of personnel. An enterprise shall take actions to ensure the implementation of such procedures.   第二十七条 人员卫生操作规程应当包括与健康、卫生习惯及人员着装相关的内容。企业应当采取措施确保人员卫生操作规程的执行。
Article 28 An enterprise shall subject its personnel to health management and create health files for them. The production personnel who have direct contact with veterinary drugs shall undergo health examinations prior to employment, and undergo health examination at least once each year.   第二十八条 企业应当对人员健康进行管理,并建立健康档案。直接接触兽药的生产人员上岗前应当接受健康检查,以后每年至少进行一次健康检查。
Article 29 An enterprise shall take proper actions to ensure that no person having open lesions on the exposed surface of the body or affected by an infectious disease or any other disease that may contaminate veterinary drugs is engaged in the manufacture in direct contact with veterinary drugs.   第二十九条 企业应当采取适当措施,避免体表有伤口、患有传染病或其他疾病可能污染兽药的人员从事直接接触兽药的生产活动。
Article 30 Visitors or untrained personnel shall not be taken into the production and quality control areas. If their entry is unavoidable under special circumstances, they shall be given instructions in advance about such matters as personal hygiene and the change of clothing.   第三十条 参观人员和未经培训的人员不得进入生产区和质量控制区,特殊情况确需进入的,应当经过批准,并对进入人员的个人卫生、更衣等事项进行指导。
Article 31 Any person entering the production areas shall change clothes as required. The materials and style of work clothes and the way he dresses shall be appropriate to the duties he performs and the requisite level of air cleanness.   第三十一条 任何进入生产区的人员均应当按照规定更衣。工作服的选材、式样及穿戴方式应当与所从事的工作和空气洁净度级别要求相适应。
Article 32 No person entering clean production areas shall make up or wear ornaments.   第三十二条 进入洁净生产区的人员不得化妆和佩带饰物。
Article 33 Smoking, eating or drinking, or the storage of food, drink, cigarettes, personal articles, or other articles for non-production use shall all be prohibited in production and storage areas.   第三十三条 生产区、检验区、仓储区应当禁止吸烟和饮食,禁止存放食品、饮料、香烟和个人用品等非生产用物品。
Article 34 Direct contact shall be avoided between the operator's bare hands and the exposed veterinary drugs as well as with the surface of the containers, packaging materials or equipment that comes into contact with the veterinary drugs.   第三十四条 操作人员应当避免裸手直接接触兽药以及与兽药直接接触的容器具、包装材料和设备表面。
Chapter IV Premises and Facilities 

第四章 厂房与设施

Section 1 Principle 

第一节 原则

Article 35 Premises must be located, designed, laid out, constructed, adapted, and maintained to suit the production of veterinary drugs to be carried out so as to minimize the risk of contamination, cross-contamination, mix-ups and errors, and facilitate effective cleaning, operation and maintenance.   第三十五条 厂房的选址、设计、布局、建造、改造和维护必须符合兽药生产要求,应当能够最大限度地避免污染、交叉污染、混淆和差错,便于清洁、操作和维护。
Article 36 Premises shall be situated in an environment that, when considered together with measures to protect the manufacturing process, prevents minimum risk of causing any contamination of materials or products.   第三十六条 应当根据厂房及生产防护措施综合考虑选址,厂房所处的环境应当能够最大限度地降低物料或产品遭受污染的风险。
Article 37 An enterprise shall have a clean production environment. The surface of the ground and roads and the transportation of the plant areas shall not be a source of contamination of veterinary drugs. The general lay-out of the production, administration, living and ancillary areas shall be appropriately arranged and not block each other. The plants shall be designed to ensure the logical flow of personnel and materials.   第三十七条 企业应当有整洁的生产环境;厂区的地面、路面等设施及厂内运输等活动不得对兽药的生产造成污染;生产、行政、生活和辅助区的总体布局应当合理,不得互相妨碍;厂区和厂房内的人、物流走向应当合理。
Article 38 Premises shall be carefully maintained, and it shall be ensured that the repair and maintenance operations do not present any hazard to the quality of products. Premises shall be cleaned and, where applicable, disinfected according to detailed written procedures.   第三十八条 应当对厂房进行适当维护,并确保维修活动不影响兽药的质量。应当按照详细的书面操作规程对厂房进行清洁或必要的消毒。
Article 39 Lighting, temperature, humidity and ventilation in premises shall be appropriate and such that they do not adversely affect, directly or indirectly, either the quality of veterinary drugs during their manufacture and storage, or the accurate functioning of equipment.   第三十九条 厂房应当有适当的照明、温度、湿度和通风,确保生产和贮存的产品质量以及相关设备性能不会直接或间接地受到影响。
Article 40 Premises and facilities shall be designed and equipped in a way that can afford maximum protection against the entry of insects or other animals. Necessary actions shall be taken to avoid the contamination of equipment, materials or products caused by raticide, pesticide, fumigant, etc.   第四十条 厂房、设施的设计和安装应当能够有效防止昆虫或其他动物进入。应当采取必要的措施,避免所使用的灭鼠药、杀虫剂、烟熏剂等对设备、物料、产品造成污染。
Article 41 Proper actions shall be taken to prevent the entry of unauthorized people. Production, storage and quality control areas shall not be used as a passageway by personnel who do not work in these areas.   第四十一条 应当采取适当措施,防止未经批准人员的进入。生产、贮存和质量控制区不得作为非本区工作人员的直接通道。
Article 42 As-built drawings of built or rebuilt premises, services and restrained lines and pipes shall be kept.   第四十二条 应当保存厂房、公用设施、固定管道建造或改造后的竣工图纸。
Section 2 Production Area 

第二节 生产区

Article 43 In order to minimize the risks of contamination and cross-contamination, the premises, manufacturing facilities and equipment shall be reasonably designed, laid out and used according to the features of the manufactured veterinary drugs, the sequence of the operations and the requisite cleanness levels, and shall meet the following requirements:   第四十三条 为降低污染和交叉污染的风险,厂房、生产设施和设备应当根据所生产兽药的特性、工艺流程及相应洁净度级别要求合理设计、布局和使用,并符合下列要求:
1. The availability of premises, manufacturing facilities and equipment for the common use of different products shall be determined by fully considering the features of veterinary drugs, processes, and other factors, and the corresponding assessment reports shall be provided. (一)应当根据兽药的特性、工艺等因素,确定厂房、生产设施和设备供多产品共用的可行性,并有相应的评估报告。
2. Relatively separate premises, manufacturing facilities and dedicated air cleaning systems must be available for the production of highly sensitizing drugs such as penicillin. A negative pressure shall be maintained relative to other rooms. Before being discharged outside of the room, the used steam (or air) shall be cleaned so as to comply with the requirements. The opening for the discharge of used steam (or air) shall be far away from the air intake of other air cleaning systems. If other products are to be dispensed from such a discontinued premise, it must be cleaned of residues, and may be used for manufacture of other products after it has passed a test. (二)生产青霉素类等高致敏性兽药应使用相对独立的厂房、生产设施及专用的空气净化系统,分装室应保持相对负压,排至室外的废气应经净化处理并符合要求,排风口应远离其他空气净化系统的进风口。如需利用停产的该类车间分装其他产品时,则必须进行清洁处理,不得有残留并经测试合格后才能生产其他产品。
3. Drugs with highly biologically active veterinary drugs (such as sex hormone type) must be manufactured with dedicated premises, manufacturing facilities and dedicated air cleaning systems, and the production area must be strictly separated from other production areas of veterinary drugs. (三)生产高生物活性兽药(如性激素类等)应使用专用的车间、生产设施及空气净化系统,并与其他兽药生产区严格分开。
4. Inhaled narcotic drugs for veterinary use shall be manufactured with dedicated premises, production facilities and air cleaning systems; relatively negative pressure shall be maintained during the fluid preparation and filling processes, and air shall be fully extracted through the air extraction systems and not be re-circulated. (四)生产吸入麻醉剂类兽药应使用专用的车间、生产设施及空气净化系统;配液和分装工序应保持相对负压,其空调排风系统采用全排风,不得利用回风方式。
5. Biological products for veterinary use shall be manufactured separately according to different types and natures of microorganisms. For virulent strains and attenuated strains, viruses and bacteria, live vaccines and inactivated vaccines, those before and after inactivation, and those before and after detoxification, their production operation areas and storage equipment, among others, shall be strictly separated. (五)兽用生物制品应按微生物类别、性质的不同分开生产。强毒菌种与弱毒菌种、病毒与细菌、活疫苗与灭活疫苗、灭活前与灭活后、脱毒前与脱毒后其生产操作区域和储存设备等应严格分开。
For the production of biological products for veterinary use involving highly pathogenic microbes as well as zoonotic bacterial pathogens and spore-forming bacteria with the risk of human infection, actions such as special areas, special equipment and special air-conditioning systems shall be taken at least on the basis of biosecurity risk assessment in order to ensure biosecurity. The production of biological products for veterinary use with the requirements of three-level biosecurity protection shall also comply with relevant rules. 生产兽用生物制品涉及高致病性病原微生物、有感染人风险的人兽共患病病原微生物以及芽孢类微生物的,应在生物安全风险评估基础上,至少采取专用区域、专用设备和专用空调排风系统等措施,确保生物安全。有生物安全三级防护要求的兽用生物制品的生产,还应符合相关规定。
6. The used steam (or air) discharged from the air-conditioning air cleaning system as mentioned in the aforesaid subparagraphs 2, 3, and 4 shall be cleaned in an innocuous way. (六)用于上述第(二)、(三)、(四)、(五)项的空调排风系统,其排风应当经过无害化处理。
7. The manufacture of non-veterinary drugs shall not be allowed in premises used for the manufacture of veterinary drugs. (七)生产厂房不得用于生产非兽药产品。
8. Separate buildings shall be set up for the production premises and warehouses of flammable, explosive and corrosive disinfectants (such as solid preparations of chlorine solutions, etc.). (八)对易燃易爆、腐蚀性强的消毒剂(如固体含氯制剂等)生产车间和仓库应设置独立的建筑物。
Article 44 The adequacy of the production and storage space shall permit the orderly and logical positioning of equipment, materials, intermediate and finished products so as to minimize the risk of confusion between different products or materials, to avoid cross-contamination, and to minimize the risk of omission or wrong application of any of the manufacturing or quality control steps.   第四十四条 生产区和贮存区应当有足够的空间,确保有序地存放设备、物料、中间产品和成品,避免不同产品或物料的混淆、交叉污染,避免生产或质量控制操作发生遗漏或差错。
Article 45 Production areas shall be effectively ventilated with an air cleaning system including control of temperature and humidity and filtration of air, appropriate to the veterinary drugs handled, to the operations undertaken and to the external environment, so as to ensure that the environment for production of veterinary drugs complies with the requirements.   第四十五条 应当根据兽药品种、生产操作要求及外部环境状况等配置空气净化系统,使生产区有效通风,并有温度、湿度控制和空气净化过滤,保证兽药的生产环境符合要求。
The pressure differential between a clean area and a non-clean area, and between two clean areas of different levels shall be at least 10 Pascal. When necessary, there shall be appropriate pressure differentials between different functional areas (rooms for operations) of the same cleanness level, and a device to indicate differential pressure and/or a monitoring system shall be provided. 洁净区与非洁净区之间、不同级别洁净区之间的压差应当不低于10帕斯卡。必要时,相同洁净度级别的不同功能区域(操作间)之间也应当保持适当的压差梯度,并应有指示压差的装置和 (或)设置监控系统。
The clean rooms (zones) for production of veterinary drugs shall be divided into four grades, i.e., grades A, B, C and D. The design of clean rooms (areas) for the production of different grades of veterinary drugs shall meet the appropriate cleanliness requirements, including “static” and “dynamic” standards. 兽药生产洁净室(区)分为A级、B级、C级和D级4个级别。生产不同类别兽药的洁净室(区)设计应当符合相应的洁净度要求,包括达到“静态”和“动态”的标准。
Article 46 The interior surfaces (walls, floors and ceilings) of clean areas shall be smooth and free from cracks and open joints, shall not shed particulate matter, shall have no dust and shall permit easy and effective cleaning and, if necessary, disinfection.   第四十六条 洁净区的内表面(墙壁、地面、天棚)应当平整光滑、无裂缝、接口严密、无颗粒物脱落,避免积尘,便于有效清洁,必要时应当进行消毒。
Article 47 The water treatment of water used for various pipework and processes and the supporting facilities thereof, light fittings, ventilation points and other public facilities shall be designed and equipped to avoid the creation of recesses that are difficult to clean. As far as possible, for maintenance purposes, they shall be accessible from outside the production areas.   第四十七条 各种管道、工艺用水的水处理及其配套设施、照明设施、风口和其他公用设施的设计和安装应当避免出现不易清洁的部位,应当尽可能在生产区外部对其进行维护。
Dried air, compressed air and inert gas that are in direct contact with sterile veterinary drugs shall be purified, and their cleanliness and pipe materials, among others, shall be consistent with the requirements of the corresponding clean areas. 与无菌兽药直接接触的干燥用空气、压缩空气和惰性气体应经净化处理,其洁净程度、管道材质等应与对应的洁净区的要求相一致。
Article 48 Drains shall be of adequate size and designed and equipped to prevent back-flow. There shall be effective innocuous disposal facilities for active toxic sewage containing highly pathogenic microbes and zoonotic bacterial pathogens with the risk of human infection.   第四十八条 排水设施应当大小适宜,并安装防止倒灌的装置。含高致病性病原微生物以及有感染人风险的人兽共患病病原微生物的活毒废水,应有有效的无害化处理设施。
Article 49 The weighing of starting materials of preparations shall be carried out in separate weighing rooms designed for such use.   第四十九条 制剂的原辅料称量通常应当在专门设计的称量室内进行。
Article 50 The rooms for processing operations where dust is generated (e.g. the rooms for the sampling, weighing, mixing, packaging and processing operations of dry materials or products) shall maintain a negative pressure relative to other rooms and special actions shall be taken to prevent the dissemination of dust and cross-contamination and to facilitate cleaning.   第五十条 产尘操作间(如干燥物料或产品的取样、称量、混合、包装等操作间)应当保持相对负压或采取专门的措施,防止粉尘扩散、避免交叉污染并便于清洁。
Article 51 Premises or areas for the packaging of veterinary drugs shall be reasonably designed and laid out so as to avoid mix-ups or cross-contamination. Separation measures shall be taken if there are several packaging lines in the same area.   第五十一条 用于兽药包装的厂房或区域应当合理设计和布局,以避免混淆或交叉污染。如同一区域内有数条包装线,应当有隔离措施。
Article 52 Production areas shall be well lit, particularly where visual controls are carried out   第五十二条 生产区应根据功能要求提供足够的照明,目视操作区域的照明应当满足操作要求。
Article 53 A testing area for intermediate products may be set up in a production area, but the testing operations for intermediate products shall not post any risk to the quality of veterinary drugs.   第五十三条 生产区内可设中间产品检验区域,但中间产品检验操作不得给兽药带来质量风险。
Section 3 Storage Areas 

第三节 仓储区

Article 54 Storage areas shall be of sufficient capacity to allow orderly storage of all kinds of materials and products: starting materials and packaging materials, and intermediate and finished products that are in quarantine, or released, rejected, returned or recalled.   第五十四条 仓储区应当有足够的空间,确保有序存放待验、合格、不合格、退货或召回的原辅料、包装材料、中间产品和成品等各类物料和产品。
Article 55 Storage areas shall be designed and built to ensure good storage conditions and have ventilation and lighting facilities. Conditions for storing materials or products (e.g. temperature, humidity and protection from light) and the requirements for safe storage shall be met, and storage areas shall be inspected and monitored.   第五十五条 仓储区的设计和建造应当确保良好的仓储条件,并有通风和照明设施。仓储区应当能够满足物料或产品的贮存条件(如温湿度、避光)和安全贮存的要求,并进行检查和监控。
Article 56 Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access shall be restricted to allow only authorized personnel.   第五十六条 如采用单独的隔离区域贮存待验物料或产品,待验区应当有醒目的标识,且仅限经批准的人员出入。
Segregation shall be provided for the storage of rejected, returned or recalled materials or products. 不合格、退货或召回的物料或产品应当隔离存放。
Any system replacing the physical quarantine shall give equivalent security. 如果采用其他方法替代物理隔离,则该方法应当具有同等的安全性。
Article 57 The premises and facilities for the production and storage of flammable, explosive and other dangerous goods shall comply with the relevant provisions of the state. The storage facilities for narcotic drugs, psychotropic drugs, and toxic drugs for veterinary use shall comply with relevant provisions.   第五十七条 易燃、易爆和其他危险品的生产和贮存的厂房设施应符合国家有关规定。兽用麻醉药品、精神药品、毒性药品的贮存设施应符合有关规定。
Article 58 Highly active materials or products and printed packaging materials shall be stored in safe and secure areas.   第五十八条 高活性的物料或产品以及印刷包装材料应当贮存于安全的区域。
Article 59 Reception, dispatch and sales areas and transshipment process shall protect materials and products from the impact of the weather (e.g. rain and snow). Reception areas shall be designed and equipped to allow containers of incoming materials to be cleaned if necessary before storage.   第五十九条 接收、发放和销售区域及转运过程应当能够保护物料、产品免受外界天气(如雨、雪)的影响。接收区的布局和设施,应当能够确保物料在进入仓储区前可对外包装进行必要的清洁。
Article 60 Facilities such as pallets shall be set up in storage areas to avoid dampening of materials and finished products.   第六十条 贮存区域应当设置托盘等设施,避免物料、成品受潮。
Article 61 There shall normally be a separate sampling area for materials. The level of air cleanness of the sampling area shall meet the requirements for production. If sampling is performed in other areas or in any other way, it shall be conducted in such a way as to prevent contamination or cross-contamination.   第六十一条 应当有单独的物料取样区,取样区的空气洁净度级别应当与生产要求相一致。如在其他区域或采用其他方式取样,应当能够防止污染或交叉污染。
Section 4 Quality Control Areas 

第四节 质量控制区

Article 62 Generally, quality control laboratories shall be separated from production areas. According to the varieties being manufactured, there shall be corresponding laboratories that meet the requirements of sterility inspection, inspection of microbiological limits and antibiotic microbiological tests. Laboratories where biological or microbiological test methods are employed shall be separated from each other.   第六十二条 质量控制实验室通常应当与生产区分开。根据生产品种,应有相应符合无菌检查、微生物限度检查和抗生素微生物检定等要求的实验室。生物检定和微生物实验室还应当彼此分开。
Article 63 Quality control laboratories shall be designed to suit the operations to be carried out in them, and avoid mix-ups and cross-contamination. There shall be adequate space for disposing samples, retaining samples and storing samples for stability studies, and keeping records.   第六十三条 实验室的设计应当确保其适用于预定的用途,并能够避免混淆和交叉污染,应当有足够的区域用于样品处置、留样和稳定性考察样品的存放以及记录的保存。
Article 64 Separate rooms may be set up for instruments with special requirements necessary to protect sensitive instruments from interference of static electricity, vibration, humidity, or other external factors.   第六十四条 有特殊要求的仪器应当设置专门的仪器室,使灵敏度高的仪器免受静电、震动、潮湿或其他外界因素的干扰。
Article 65 The laboratories handling biological samples or other special articles shall comply with the relevant requirements of the state.   第六十五条 处理生物样品等特殊物品的实验室应当符合国家的有关要求。
Article 66 Animal houses for laboratory purpose shall be well isolated from other areas, and their design and construction shall comply with the relevant provisions of the state, and they shall have separate air-handling facilities and special passageway for animals. Animal houses where animals intended or used for production of biological products for veterinary use are accommodated, shall be separate from other animal accommodation, and shall be provided with dedicated air treatment facilities and special passageways for animals.   第六十六条 实验动物房应当与其他区域严格分开,其设计、建造应当符合国家有关规定,并设有专用的空气处理设施以及动物的专用通道。如需采用动物生产兽用生物制品,生产用动物房必须单独设置,并设有专用的空气处理设施以及动物的专用通道。
A manufacturer of biological products for veterinary use shall set up an animal laboratory for testing purposes. For those manufacturers of different biological products controlled by the same group, each manufacturer may separately set up its own animal laboratory for testing purpose or entrust another manufacturer with appropriate testing conditions and capabilities within the group with the relevant animal experiments. Laboratories and animal laboratories where the test of biological products for veterinary use with the requirements of three-level biosecurity protection are carried out shall also comply with relevant provisions. 生产兽用生物制品的企业应设置检验用动物实验室。同一集团控股的不同生物制品生产企业,可由每个生产企业分别设置检验用动物实验室或委托集团内具备相应检验条件和能力的生产企业进行有关动物实验。有生物安全三级防护要求的兽用生物制品检验用实验室和动物实验室,还应符合相关规定。
In the production of veterinary drugs other than biological products for veterinary use that require animals to be used for testing, a manufacturer of veterinary drugs may set up its own animal laboratory for testing purpose or entrust other entities with the relevant animal experiments. For a contract acceptor of any test, its animal laboratory for testing purpose must have the corresponding testing conditions and meet the relevant requirements. In the case of contract testing, the contract giver shall be responsible for the testing results. 生产兽用生物制品外其他需使用动物进行检验的兽药产品,兽药生产企业可采取自行设置检验用动物实验室或委托其他单位进行有关动物实验。接受委托检验的单位,其检验用动物实验室必须具备相应的检验条件,并应符合相关规定要求。采取委托检验的,委托方对检验结果负责。
Section 5 Ancillary Areas 

第五节 辅助区

Article 67 The setup of rest and refreshment rooms shall not cause any adverse effects on the production, storage or quality control areas.   第六十七条 休息室的设置不得对生产区、仓储区和质量控制区造成不良影响。
Article 68 The rooms for changing clothes and for washing and toilet purposes shall be easily accessible and appropriate for the number of users. Toilets shall not directly communicate with production or storage areas.   第六十八条 更衣室和盥洗室应当方便人员进出,并与使用人数相适应。盥洗室不得与生产区和仓储区直接相通。
Article 69 Maintenance workshops shall, if possible, be separated from production areas. Whenever parts and tools are stored in the clean area, they shall be kept in rooms or lockers reserved for that purpose.   第六十九条 维修间应当尽可能远离生产区。存放在洁净区内的维修用备件和工具,应当放置在专门的房间或工具柜中。
Chapter V Equipment 

第五章 设 备

Section 1 Principle 

第一节 原则

Article 70 Equipment must be designed, selected, installed, adapted, and maintained to suit its intended purpose, and minimize the risks of contamination, cross-contamination, mix-ups and errors, so as to permit easy operation, cleaning and maintenance and, if necessary, disinfection or sterilization.   第七十条 设备的设计、选型、安装、改造和维护必须符合预定用途,应当尽可能降低产生污染、交叉污染、混淆和差错的风险,便于操作、清洁、维护以及必要时进行的消毒或灭菌。
Article 71 There shall be procedures for the usage, cleaning, maintenance and repair of equipment and the relevant operating records shall be kept.   第七十一条 应当建立设备使用、清洁、维护和维修的操作规程,以保证设备的性能,应按规程使用设备并记录。
Article 72 Equipment files shall be maintained for main production and inspection equipment, instruments, and weighing equipment, including manufacturers, models, specifications, technical parameters, manuals, equipment drawings, list of spare parts, installation location and as-built construction drawings, as well as repair and maintenance records, validation records, accident records, etc.   第七十二条 主要生产和检验设备、仪器、衡器均应建立设备档案,内容包括:生产厂家、型号、规格、技术参数、说明书、设备图纸、备件清单、安装位置及竣工图,以及检修和维修保养内容及记录、验证记录、事故记录等。
Section 2 Design and Installation 

第二节 设计和安装

Article 73 Production equipment shall not present any hazard to the quality of veterinary drugs. The surface of the production equipment that comes into contact with veterinary drugs shall be smooth, bright and clean, easy to clean or disinfect, anti-corrosive, and must not chemically react with veterinary drugs, adsorb veterinary drugs, or release substances into veterinary drugs to affect the quality of products.   第七十三条 生产设备应当避免对兽药质量产生不利影响。与兽药直接接触的生产设备表面应当平整、光洁、易清洗或消毒、耐腐蚀,不得与兽药发生化学反应、吸附兽药或向兽药中释放物质而影响产品质量。
Article 74 The performance and parameters of production and testing equipment shall meet the design requirements and actual production needs. Weighing apparatus, measuring equipment, apparatus and meter of an appropriate range and precision shall be available. The relevant equipment shall also meet the requirements for electronic traceability management of veterinary drugs.   第七十四条 生产、检验设备的性能、参数应能满足设计要求和实际生产需求,并应当配备有适当量程和精度的衡器、量具、仪器和仪表。相关设备还应符合实施兽药产品电子追溯管理的要求。
Article 75 Appropriate washing and cleaning equipment shall be chosen and used and be prevented from becoming a source of contamination.   第七十五条 应当选择适当的清洗、清洁设备,并防止这类设备成为污染源。
Article 76 No lubricants, coolants, etc. used for equipment shall contaminate veterinary drugs or containers, and the lubricants of the edible level or an equivalent level shall be used in parts that might be in contact with veterinary drugs.   第七十六条 设备所用的润滑剂、冷却剂等不得对兽药或容器造成污染,与兽药可能接触的部位应当使用食用级或级别相当的润滑剂。
Article 77 There shall be procedures for the purchase, check and acceptance, safekeeping, maintenance, distribution and scrapping of moulds for production, and such moulds shall be kept by designated persons in special areas, and be recorded.   第七十七条 生产用模具的采购、验收、保管、维护、发放及报废应当制定相应操作规程,设专人专柜保管,并有相应记录。
Section 3 Use, Repair and Maintenance 

第三节 使用、维护和维修

Article 78 There shall be specific operating procedures for main production and testing equipment.   第七十八条 主要生产和检验设备都应当有明确的操作规程。
Article 79 Production equipment shall be used within the confirmed scope of parameters.   第七十九条 生产设备应当在确认的参数范围内使用。
Article 80 There shall be an obvious status mark on production equipment to show the reference number, name, and operation status of the equipment. The equipment in operation shall show the information on the contents (e.g. name, specification, batch number, etc.); and the cleanliness status shall be labeled on the equipment if there are no contents in it.   第八十条 生产设备应当有明显的状态标识,标明设备编号、名称、运行状态等。运行的设备应当标明内容物的信息,如名称、规格、批号等,没有内容物的生产设备应当标明清洁状态。
Article 81 Main fixed pipework shall be clearly labeled to indicate the contents and the direction of flow.   第八十一条 与设备连接的主要固定管道应当标明内容物名称和流向。
Article 82 Preventive maintenance plans shall be prepared, and equipment maintenance and repair operations shall be recorded.   第八十二条 应当制定设备的预防性维护计划,设备的维护和维修应当有相应的记录。
Article 83 Equipment repair and maintenance operations shall maintain the functioning of equipment, and refrain from affecting the quality of products.   第八十三条 设备的维护和维修应保持设备的性能,并不得影响产品质量。
Article 84 Equipment that has been subject to reconstruction or major repair operations can only be put into production after it is qualified to be in compliance with the relevant requirements.   第八十四条 经改造或重大维修的设备应当进行再确认,符合要求后方可继续使用。
Article 85 Defective equipment shall be removed from production and quality control areas if possible, and before its removal, its status shall be clearly labeled.   第八十五条 不合格的设备应当搬出生产和质量控制区,如未搬出,应当有醒目的状态标识。
Article 86 There shall be a logbook on the equipment and apparatuses used for production or testing of veterinary drugs, which shall include the information on use, the date and time of use, the name, specification, batch number, etc. of veterinary drugs produced and tested.   第八十六条 用于兽药生产或检验的设备和仪器,应当有使用和维修、维护记录,使用记录内容包括使用情况、日期、时间、所生产及检验的兽药名称、规格和批号等。
Section 4 Cleaning and Hygiene 

第四节 清洁和卫生

Article 87 The production equipment of veterinary drugs shall be kept in a clean state, and avoid contamination or cross-contamination to the production of veterinary drugs.   第八十七条 兽药生产设备应保持良好的清洁卫生状态,不得对兽药的生产造成污染和交叉污染。
Article 88 Cleaning operation procedures shall be developed for production or inspection equipment and apparatus, and cleaning operations shall be made and recorded according to the procedures.   第八十八条 生产、检验设备及器具均应制定清洁操作规程,并按照规程进行清洁和记录。
Article 89 The production equipment that has been cleaned shall be stored under clean and dry conditions.   第八十九条 已清洁的生产设备应当在清洁、干燥的条件下存放。
Section 5 Verification or Calibration 

第五节 检定或校准

Article 90 Verification (calibration) plans shall be prepared for weighing apparatus, measuring equipment, instruments, and recording and control equipment and apparatuses for production and testing purposes according to national standards and characteristics of using instruments, and the range of verification (calibration) shall be suitable for their actual use. Verification or calibration shall be carried out as planned, and relevant certificates, reports or records shall be kept.   第九十条 应当根据国家标准及仪器使用特点对生产和检验用衡器、量具、仪表、记录和控制设备以及仪器制定检定(校准)计划,检定(校准)的范围应当涵盖实际使用范围。应按计划进行检定或校准,并保存相关证书、报告或记录。
Article 91 Weighing apparatus, measuring equipment, instruments and apparatuses used for production and testing shall be calibrated and control equipment shall be qualified to ensure that the data obtained are accurate and reliable.   第九十一条 应当确保生产和检验使用的衡器、量具、仪器仪表经过校准,控制设备得到确认,确保得到的数据准确、可靠。
Article 92 The verification and calibration of instruments shall comply with the relevant provisions of the state and ensure the effectiveness of verified or calibrated data.   第九十二条 仪器的检定和校准应当符合国家有关规定,应保证校验数据的有效性。
Self-calibration procedures shall be developed for self-calibration instruments and measuring instruments, and such instruments shall meet the conditions for self-calibration facilities. Verification or calibration personnel shall be appropriately qualified and make verification or calibration records. 自校仪器、量具应制定自校规程,并具备自校设施条件,校验人员具有相应资质,并做好校验记录。
Article 93 The weighing apparatus, measuring equipment, instrument and the equipment and apparatuses used for recording and control shall be clearly labeled with the expiry date of calibration.   第九十三条 衡器、量具、仪表、用于记录和控制的设备以及仪器应当有明显的标识,标明其检定或校准有效期。
Article 94 Automated or electronic equipment used in the course of production, packaging or storage shall be calibrated and inspected on a regular basis under the procedures so as to ensure that they function correctly. The calibration and inspection shall be recorded.   第九十四条 在生产、包装、仓储过程中使用自动或电子设备的,应当按照操作规程定期进行校准和检查,确保其操作功能正常。校准和检查应当有相应的记录。
Section 6 Water for Pharmaceutical Use 

第六节 制药用水

Article 95 Water for pharmaceutical use shall be suitable for its intended use, and meet the quality standards and the relevant requirements of the Pharmacopoeia of the People's Republic of China. Such water shall be at least drinking water.   第九十五条 制药用水应当适合其用途,并符合《中华人民共和国兽药典》的质量标准及相关要求。制药用水至少应当采用饮用水。
Article 96 The design, installment, operation and maintenance of water processing equipment and the transmission system thereof shall ensure that the water for pharmaceutical use meets the defined quality standards. The water processing equipment shall not be operated beyond its designed capacity.   第九十六条 水处理设备及其输送系统的设计、安装、运行和维护应当确保制药用水达到设定的质量标准。水处理设备的运行不得超出其设计能力。
Article 97 The materials used for storage tanks and transmission pipelines of purified water and water for injections shall be innocuous and anti-corrosive. The hydrophobic bacterial filter with no fiber loss shall be installed in the intake of storage tanks. Dead angle and blind pipe shall be avoided in the design and installment of pipes.   第九十七条 纯化水、注射用水储罐和输送管道所用材料应当无毒、耐腐蚀;储罐的通气口应当安装不脱落纤维的疏水性除菌滤器;管道的设计和安装应当避免死角、盲管。
Article 98 Purified water and water for injections shall be prepared, stored and distributed to prevent the growth of microorganisms. Purified water shall be circulated, and the water for injections shall be circulated at a temperature of 70℃ or above.   第九十八条 纯化水、注射用水的制备、贮存和分配应当能够防止微生物的滋生。纯化水可采用循环,注射用水可采用70℃以上保温循环。
Article 99 The quality of water for pharmaceutical use and raw water shall be monitored on a regular basis and be recorded.   第九十九条 应当对制药用水及原水的水质进行定期监测,并有相应的记录。
Article 100 The pipes of purified water and water for injections shall be cleaned and disinfected under the procedures and be recorded. If the microorganism pollution of water for pharmaceutical use exceeds the alert or action limit, actions shall be taken according to the procedures.   第一百条 应当按照操作规程对纯化水、注射用水管道进行清洗消毒,并有相关记录。发现制药用水微生物污染达到警戒限度、纠偏限度时应当按照操作规程处理。
Chapter VI Materials and Products 

第六章 物料与产品

Section 1 Principle 

第一节 原则

Article 101 The starting materials used in the manufacture of veterinary drugs and packaging materials in direct contact with veterinary drugs shall comply with the standards for veterinary drugs, drugs, packaging materials or other relevant standards. The oil and ink used for directly printing words on the products shall comply with the edible standards.   第一百零一条 兽药生产所用的原辅料、与兽药直接接触的包装材料应当符合兽药标准、药品标准、包装材料标准或其他有关标准。兽药上直接印字所用油墨应当符合食用标准要求。
Imported starting materials shall comply with the relevant provisions of the state on import administration. 进口原辅料应当符合国家相关的进口管理规定。
Article 102 There shall be procedures for materials and products, so as to ensure their correct receiving, storage, distribution, use and sale, and prevent contamination, cross-contamination, mix-ups and errors.   第一百零二条 应当建立相应的操作规程,确保物料和产品的正确接收、贮存、发放、使用和销售,防止污染、交叉污染、混淆和差错。
Materials and products shall be handled under the procedures or master formula, and be recorded. 物料和产品的处理应当按照操作规程或工艺规程执行,并有记录。
Article 103 Material suppliers shall be determined and changed upon quality assessment, and materials can only be purchased upon the approval of the quality management department. On-site investigations of critical materials shall be conducted when necessary.   第一百零三条 物料供应商的确定及变更应当进行质量评估,并经质量管理部门批准后方可采购。必要时对关键物料进行现场考查。
Article 104 Materials and products shall be transported in a way that their quality can be guaranteed, and the transportation conditions shall be qualified in the case of any special requirement for transportation.   第一百零四条 物料和产品的运输应当能够满足质量和安全的要求,对运输有特殊要求的,其运输条件应当予以确认。
Article 105 There shall be procedures for the receipt of each delivery of starting material and primary and printed packaging material, and all incoming materials shall be checked to ensure that the consignment corresponds to the order, and the supplier has been approved by the quality management department.   第一百零五条 原辅料、与兽药直接接触的包装材料和印刷包装材料的接收应当有操作规程,所有到货物料均应当检查,确保与订单一致,并确认供应商已经质量管理部门批准。
The containers of materials shall be labeled with the prescribed information. The containers shall be cleaned where necessary. Damage to containers and any other problem that might adversely affect the quality of a material shall be reported to the quality management department and investigated and recorded. 物料的外包装应当有标签,并注明规定的信息。必要时应当进行清洁,发现外包装损坏或其他可能影响物料质量的问题,应当向质量管理部门报告并进行调查和记录。
The records of the receipt of each delivery shall include: 每次接收均应当有记录,内容包括:
1. the name of the material on the delivery note and the containers; (一)交货单和包装容器上所注物料的名称;
2. the “in-house” name and/or code of the material; (二)企业内部所用物料名称和(或)代码;
3. the date of receipt; (三)接收日期;
4. the supplier's name and the manufacturer's name (if different); (四)供应商和生产商(如不同)的名称;
5. the batch number marked by the supplier or the manufacturer (if different); (五)供应商和生产商(如不同)标识的批号;
6. the total quantity and number of containers received; (六)接收总量和包装容器数量;
7. the batch or serial number assigned by the enterprise after receipt; (七)接收后企业指定的批号或流水号;
8. any relevant comment (e.g. state of the containers); and (八)有关说明(如包装状况);
9. the inspection reports and other conformity certification materials. (九)检验报告单等合格性证明材料。
Article 106 All incoming materials and finished products shall be quarantined immediately after receipt or processing, until they are released.   第一百零六条 物料接收和成品生产后应当及时按照待验管理,直至放行。
Article 107 All materials and products shall be stored according to their nature and in an orderly manner to permit stock rotation, distribution and sales by a first-to-expire, first-out rule.
......
   第一百零七条 物料和产品应当根据其性质有序分批贮存和周转,发放及销售应当符合先进先出和近效期先出的原则。
......

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