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Order of the Ministry of Health
(No.79)
The Good Manufacturing Practices for Pharmaceutical Products (revised edition 2010), as deliberated and adopted at the executive meeting of the Ministry of Health on October 19, 2010, are hereby issued, and shall come into force on March 1, 2011.
Minister: Chen Zhu
January 17, 2011
Good Manufacturing Practices for Pharmaceutical Products (Revised 2010)
| | 卫生部令
（第79号）
《药品生产质量管理规范（2010年修订）》已于2010年10月19日经卫生部部务会议审议通过，现予以发布，自2011年3月1日起施行。
部 长 陈竺
二○一一年一月十七日
药品生产质量管理规范（2010年修订）
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Chapter I General Provisions
| | 第一章 总 则
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Article 1 To regulate the administration of production and quality of pharmaceutical products, the Good Manufacturing Practices for Pharmaceutical Products (“GMP for Pharmaceutical Products”) are formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China and the Regulation for the Implementation of the Pharmaceutical Administration Law of the People's Republic of China.
| | 第一条 为规范药品生产质量管理，根据《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》，制定本规范。
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Article 2 An enterprise should establish a quality management system for pharmaceutical products, which should cover all factors affecting the quality of pharmaceutical products, and all arrangements ensuring that the pharmaceutical products are fit for their intended use.
| | 第二条 企业应当建立药品质量管理体系。该体系应当涵盖影响药品质量的所有因素，包括确保药品质量符合预定用途的有组织、有计划的全部活动。
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Article 3 GMP for Pharmaceutical Products, as a part of the quality management system, serves as the basic requirements for pharmaceutical production management and quality control, aims to minimize the risk of contamination, cross-contamination, mix-ups, errors, etc. during the manufacturing process of pharmaceutical products, and to ensure the continuous and stable production of pharmaceutical products which are fit for their intended use, and comply with the requirements of the marketing authorization.
| | 第三条 本规范作为质量管理体系的一部分，是药品生产管理和质量控制的基本要求，旨在最大限度地降低药品生产过程中污染、交叉污染以及混淆、差错等风险，确保持续稳定地生产出符合预定用途和注册要求的药品。
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Article 4 An enterprise should strictly implement GMP for Pharmaceutical Products, adhere to honesty and good faith, and prohibit any falsehood or fraud.
| | 第四条 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。
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Chapter II Quality Management
| | 第二章 质量管理
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Section 1 Principle
| | 第一节 原 则
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Article 5 An enterprise should set the quality objective meeting the requirements for the quality management of pharmaceutical products, systematically implement all requirements for the safety, effectiveness and quality control of pharmaceutical registration during the whole process of pharmaceutical production, control, product release, storage and dispatch, so as to ensure that the manufactured products are fit for their intended use and comply with the requirements of the marketing authorization.
| | 第五条 企业应当建立符合药品质量管理要求的质量目标，将药品注册的有关安全、有效和质量可控的所有要求，系统地贯彻到药品生产、控制及产品放行、贮存、发运的全过程中，确保所生产的药品符合预定用途和注册要求。
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Article 6 The attainment of the predetermined quality objective is the responsibility of senior management and requires the participation and commitment of staff at all levels within the enterprise, the enterprise's suppliers, and the distributors.
| | 第六条 企业高层管理人员应当确保实现既定的质量目标，不同层次的人员以及供应商、经销商应当共同参与并承担各自的责任。
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Article 7 An enterprise should have an adequate number of competent personnel, premises, facilities and equipment to provide necessary conditions for the attainment of the quality objective.
| | 第七条 企业应当配备足够的、符合要求的人员、厂房、设施和设备，为实现质量目标提供必要的条件。
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Section II Quality Assurance
| | 第二节 质量保证
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Article 8 Quality assurance is a part of the quality management system. 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.
| | 第八条 质量保证是质量管理体系的一部分。企业必须建立质量保证系统，同时建立完整的文件体系，以保证系统有效运行。
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Article 9 The quality assurance system should ensure that:
| | 第九条 质量保证系统应当确保：
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1. pharmaceutical products are designed and developed in a way that satisfies the requirements of GMP for Pharmaceutical Products;
| | （一）药品的设计与研发体现本规范的要求；
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2. production management and quality control operations comply with the requirements of GMP for Pharmaceutical Products;
| | （二）生产管理和质量控制活动符合本规范的要求；
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3. managerial responsibilities are clearly specified;
| | （三）管理职责明确；
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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正确无误；
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5. intermediate products are subject to effective control;
| | （五）中间产品得到有效控制；
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6. qualifications and validations are carried out;
| | （六）确认、验证的实施；
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7. the product is manufactured, 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；
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8. each batch of products are released only upon the approval of the authorized person;
| | （八）每批产品经质量受权人批准后方可放行；
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9. satisfactory arrangements exist to ensure that the pharmaceutical products are stored, dispatched, and subsequently handled in the way that quality is maintained; and
| | （九）在贮存、发运和随后的各种操作过程中有保证药品质量的适当措施；
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10. the effectiveness and applicability of the quality assurance system are regularly inspected and appraised according to the procedure for self-inspection.
| | （十）按照自检操作规程，定期检查评估质量保证系统的有效性和适用性。
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Article 10 The basic requirements for the quality management of pharmaceutical production are:
| | 第十条 药品生产质量管理的基本要求：
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1. all manufacturing processes are defined, systematically reviewed, and shown to be capable of consistently and steadily manufacturing pharmaceutical products that comply with their specifications;
| | （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；
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2. the manufacturing processes and the material changes thereof are validated;
| | （二）生产工艺及其重大变更均经过验证；
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3. necessary resources are provided, at least including:
| | （三）配备所需的资源，至少包括：
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(1) appropriately qualified and trained personnel;
| | 1.具有适当的资质并经培训合格的人员；
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(2) adequate premises and space;
| | 2.足够的厂房和空间；
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(3) suitable equipment and maintenance;
| | 3.适用的设备和维修保障；
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(4) correct starting materials, packaging materials and labels;
| | 4.正确的原辅料、包装材料和标签；
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(5) approved master formula and procedures; and
| | 5.经批准的工艺规程和操作规程；
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(6) suitable storage and transport.
| | 6.适当的贮运条件。
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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；
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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；
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6. records are made during the whole manufacturing process and deviations are investigated and recorded;
| | （六）生产全过程应当有记录，偏差均经过调查并记录；
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7. batch records and dispatch records, which enable the complete history of a batch to be traced, are retained in a proper and accessible form;
| | （七）批记录和发运记录应当能够追溯批产品的完整历史，并妥善保存、便于查阅；
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8. any risk to the quality of pharmaceutical products is minimized during their dispatch;
| | （八）降低药品发运过程中的质量风险；
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9. a system is available to recall any batch of products from dispatch or sale; and
| | （九）建立药品召回系统，确保能够召回任何一批已发运销售的产品；
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10. complaints about pharmaceutical products are examined, causes of quality defects investigated, and measures taken in respect of the defective products to prevent recurrence.
| | （十）调查导致药品投诉和质量缺陷的原因，并采取措施，防止类似质量缺陷再次发生。
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Section 3 Quality Control
| | 第三节 质量控制
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Article 11 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.
| | 第十一条 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。
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Article 12 The basic requirements for quality control are as follows:
| | 第十二条 质量控制的基本要求：
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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；
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2. approved procedures must be available for sampling, inspecting, and testing starting materials, packaging materials, and intermediate, bulk, 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、待包装产品和成品的取样、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；
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3. samples of starting materials, packaging materials, and intermediate, bulk 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、待包装产品和成品取样；
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4. test methods must be qualified or validated;
| | （四）检验方法应当经过验证或确认；
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5. records must be made in sampling, inspection and testing and any deviations must be recorded and investigated;
| | （五）取样、检查、检验应当有记录，偏差应当经过调查并记录；
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6. the materials and intermediate, bulk and finished products must be inspected and tested against specifications, and records must be made; and
| | （六）物料、中间产品、待包装产品和成品必须按照质量标准进行检查和检验，并有记录；
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7. sufficient samples of materials and final products must be retained to permit future inspection or testing of the product; the retained sample product must be kept in its final pack unless the pack is exceptionally large.
| | （七）物料和最终包装的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。
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Section 4 Quality Risk Management
| | 第四节 质量风险管理
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Article 13 Quality risk management is a systematic process incorporating the evaluation, control, communication and examination of quality risks in a forward-looking or retrospective manner during the whole life cycle of products.
| | 第十三条 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，对质量风险进行评估、控制、沟通、审核的系统过程。
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Article 14 Quality risks should be appraised based on scientific knowledge and experiences so as to guarantee the required quality of products.
| | 第十四条 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。
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Article 15 The methods or measures taken during the process of quality risk management, the form thereof and the documents prepared should match the degree of existing risks.
| | 第十五条 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。
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Chapter III Organization and Personnel
| | 第三章 机构与人员
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Section 1 Principle
| | 第一节 原 则
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Article 16 An enterprise should establish a management department appropriate for its pharmaceutical production, and have an organization chart.
An enterprise should 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.
| | 第十六条 企业应当建立与药品生产相适应的管理机构，并有组织机构图。
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。
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Article 17 A quality management department should participate in all activities relating to quality and be responsible for examining all documents relating to GMP for Pharmaceutical Products. No person of the quality management department should entrust his functions to a person of any other department.
| | 第十七条 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。
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Article 18 An enterprise should 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 should be no gaps or unexplained overlaps with regard to the functions of posts. The responsibilities placed on any one individual should not be too extensive.
All personnel should have a clear understanding of his functions, be aware of the requirements that affect them, and receive necessary training, including pre-job training and continuing training.
| | 第十八条 企业应当配备足够数量并具有适当资质（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。每个人所承担的职责不应当过多。
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。
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Article 19 No person should entrust his functions to any other person, and if it is necessary, he may entrust his functions to a qualified designated person.
| | 第十九条 职责通常不得委托给他人。确需委托的，其职责可委托给具有相当资质的指定人员。
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Section 2 Key Personnel
| | 第二节 关键人员
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Article 20 Key personnel should be full-time personnel of the enterprise, which should at least include the person in charge of the enterprise, the head of production, the head of quality management and the authorized person.
The head of quality management and the head of production should not be the same person, while the head of quality management and the authorized person may be the same person. There should be procedures to ensure the independent fulfillment of functions of the authorized person, and prevent him from disturbance by the person in charge of the enterprise and other personnel.
| | 第二十条 关键人员应当为企业的全职人员，至少应当包括企业负责人、生产管理负责人、质量管理负责人和质量受权人。
质量管理负责人和生产管理负责人不得互相兼任。质量管理负责人和质量受权人可以兼任。应当制定操作规程确保质量受权人独立履行职责，不受企业负责人和其他人员的干扰。
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Article 21 Person in Charge of the Enterprise
The person in charge of the enterprise is the principal person responsible for the quality of pharmaceutical products, and takes overall responsibility for the daily management of the enterprise. To ensure the attainment of the quality objective and the production of pharmaceutical products under GMP for Pharmaceutical Products, the person in charge of the enterprise should 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.
| | 第二十一条 企业负责人
企业负责人是药品质量的主要责任人，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药品，企业负责人应当负责提供必要的资源，合理计划、组织和协调，保证质量管理部门独立履行其职责。
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Article 22 Head of Production
| | 第二十二条 生产管理负责人
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1. Qualification:
The head of production should at least have a university diploma at the undergraduate course level in pharmacy or the relevant specialty (or intermediate professional technical title or the qualification of licensed pharmacist), have a three-year or more experience in the manufacture and quality management of pharmaceutical products, including an experience of one year or more in the production management of pharmaceutical products, and have received training on the professional knowledge relating to the products manufactured.
| | （一）资质：
生产管理负责人应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格），具有至少三年从事药品生产和质量管理的实践经验，其中至少有一年的药品生产管理经验，接受过与所生产产品相关的专业知识培训。
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2. Major functions:
| | （二）主要职责：
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(1) to ensure that pharmaceutical products are manufactured and stored according to the approved master formula in order to obtain the required quality;
| | 1.确保药品按照批准的工艺规程生产、贮存，以保证药品质量；
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(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；
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(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经过指定人员审核并送交质量管理部门；
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(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；
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(5) to ensure that all necessary validations are carried out; and
| | 5.确保完成各种必要的验证工作；
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(6) to ensure that the required pre-job and continuing training of production personnel is carried out and adapted 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。
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Article 23 Head of Quality Management
| | 第二十三条 质量管理负责人
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1. Qualification:
The head of quality management should at least have a university diploma at the undergraduate course level in pharmacy or the relevant specialty (or intermediate professional technical title or the qualification of licensed pharmacist), have a five-year or more experience in the manufacture and quality management of pharmaceutical products, including an experience of one year or more in the quality management of pharmaceutical products, and have received training on the professional knowledge relating to the products manufactured.
| | （一）资质：
质量管理负责人应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格），具有至少五年从事药品生产和质量管理的实践经验，其中至少一年的药品质量管理经验，接受过与所生产产品相关的专业知识培训。
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2. Major functions:
| | （二）主要职责：
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(1) to ensure that the starting materials, packaging materials, and intermediate, bulk and finished products comply with the registered and approved requirements and specifications;
| | 1.确保原辅料、包装材料、中间产品、待包装产品和成品符合经注册批准的要求和质量标准；
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(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；
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(3) to ensure that all necessary testing is carried out;
| | 3.确保完成所有必要的检验；
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(4) to approve specifications, 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；
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(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；
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(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；
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(7) to approve and monitor analyses carried out under contract;
| | 7.批准并监督委托检验；
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(8) to monitor the maintenance of premises and equipment so as to keep them in sound operation;
| | 8.监督厂房和设备的维护，以保持其良好的运行状态；
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(9) to ensure that all necessary qualifications or validations are carried out, and to examine and approve the qualification or validation plans and reports;
| | 9.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；
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(10) to ensure that the self-inspection is carried out;
| | 10.确保完成自检；
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(11) to appraise and approve material suppliers;
| | 11.评估和批准物料供应商；
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(12) to ensure that all complaints relating to product quality have been investigated and handled in a timely and accurate manner;
| | 12.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；
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(13) to ensure that product continuous stability studies are carried out and the data on stability studies are provided;
| | 13.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；
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(14) to ensure that the product quality review is carried out; and
| | 14.确保完成产品质量回顾分析；
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(15) to ensure that the required pre-job and continuing training of quality control and quality assurance personnel is carried out and adapted according to the actual need.
| | 15.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。
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Article 24 The head of production and the head of quality management generally have the following shared responsibilities:
| | 第二十四条 生产管理负责人和质量管理负责人通常有下列共同的职责：
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1. to examine and approve the master formula, procedures and other documents of products;
| | （一）审核和批准产品的工艺规程、操作规程等文件；
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2. to monitor plant hygiene;
| | （二）监督厂区卫生状况；
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3. to ensure that the key equipment has been qualified;
| | （三）确保关键设备经过确认；
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4. to ensure that the manufacturing process is validated;
| | （四）确保完成生产工艺验证；
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5. to ensure that the required pre-job and continuing training of all relevant personnel of the enterprise is carried out and adapted according to the actual need;
| | （五）确保企业所有相关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；
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6. to approve and monitor contract production;
| | （六）批准并监督委托生产；
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7. to determine and monitor the storage conditions for materials and products;
| | （七）确定和监控物料和产品的贮存条件；
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8. to keep records;
| | （八）保存记录；
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9. to monitor the compliance with the requirements of GMP for Pharmaceutical Products; and
| | （九）监督本规范执行状况；
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10. to monitor factors that may affect product quality.
| | （十）监控影响产品质量的因素。
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Article 25 Authorized Person
| | 第二十五条 质量受权人
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1. Qualification:
The authorized person should at least have a university diploma at the undergraduate course level in pharmacy or the relevant specialty (or intermediate professional technical title or the qualification of licensed pharmacist), have a five-year or more practical experience in the production and quality management of pharmaceutical products, and have engaged in the work of manufacturing process control and quality inspection of pharmaceutical products.
The authorized person should have necessary professional theoretical knowledge and received training relating to product release before independently performing his functions.
| | （一）资质：
质量受权人应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格），具有至少五年从事药品生产和质量管理的实践经验，从事过药品生产过程控制和质量检验工作。
质量受权人应当具有必要的专业理论知识，并经过与产品放行有关的培训，方能独立履行其职责。
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2. Major functions:
| | （二）主要职责：
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(1) to participate in the establishment of the enterprise's quality system, internal self-inspection, external quality audit, validation, reporting of adverse reactions of pharmaceutical products, product recalls and other quality management activities;
| | 1.参与企业质量体系建立、内部自检、外部质量审计、验证以及药品不良反应报告、产品召回等质量管理活动；
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(2) to assume the functions of releasing products and ensure that the production and analyses of each batch released comply with the relevant laws, regulations, requirements of marketing authorization and specifications of pharmaceutical products; and
| | 2.承担产品放行的职责，确保每批已放行产品的生产、检验均符合相关法规、药品注册要求和质量标准；
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(3) to issue product release examination records according to the requirements of the aforesaid subparagraph (2) before releasing products, and include the records in the batch records.
| | 3.在产品放行前，质量受权人必须按照上述第2项的要求出具产品放行审核记录，并纳入批记录。
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Section 3 Training
| | 第三节 培 训
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Article 26 An enterprise should 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 should be kept.
| | 第二十六条 企业应当指定部门或专人负责培训管理工作，应当有经生产管理负责人或质量管理负责人审核或批准的培训方案或计划，培训记录应当予以保存。
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Article 27 All personnel relating to pharmaceutical production and quality should receive training appropriate for the duties assigned to them. Besides the training on the theory and practice of GMP for Pharmaceutical Products, the training on the relevant laws and regulations, functions and skills for the corresponding posts should be given, and its practical effectiveness should be periodically assessed.
| | 第二十七条 与药品生产、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，并定期评估培训的实际效果。
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Article 28 Personnel working in areas with hazards (e.g. production areas where highly active, toxic, infectious or sensitizing materials are handled) should be given a specific training.
| | 第二十八条 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培训。
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Section 4 Personal Hygiene
| | 第四节 人员卫生
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Article 29 All personnel should be trained in the practices of personal hygiene, and an enterprise should prepare personal hygiene procedures so as to minimize the risk of product contamination by personnel.
| | 第二十九条 所有人员都应当接受卫生要求的培训，企业应当建立人员卫生操作规程，最大限度地降低人员对药品生产造成污染的风险。
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Article 30 Personal hygiene procedures should include the contents relating to health and sanitary practices and the clothing of personnel. The personnel in production and quality control areas should have an accurate understanding of the relevant personal hygiene procedures. An enterprise should take actions to ensure the implementation of such procedures.
| | 第三十条 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。生产区和质量控制区的人员应当正确理解相关的人员卫生操作规程。企业应当采取措施确保人员卫生操作规程的执行。
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Article 31 An enterprise should subject its personnel to health management and create health files for them. The production personnel who have direct contact with pharmaceutical products should undergo health examinations prior to employment, and undergo health examination at least once each year.
| | 第三十一条 企业应当对人员健康进行管理，并建立健康档案。直接接触药品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。
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Article 32 An enterprise should take proper actions to avoid any person who has open lesions, infectious disease or any other disease that may contaminate pharmaceutical products from assuming production in direct contact with pharmaceutical products.
| | 第三十二条 企业应当采取适当措施，避免体表有伤口、患有传染病或其他可能污染药品疾病的人员从事直接接触药品的生产。
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Article 33 Visitors or untrained personnel should preferably not be taken into the production and quality control areas. If their entry is unavoidable under special circumstances, they should be given instructions in advance about such matters as personal hygiene and the change of clothing.
| | 第三十三条 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，应当事先对个人卫生、更衣等事项进行指导。
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Article 34 Any person entering the production areas should change clothes as required. The materials and style of work clothes and the way he dresses should be appropriate to the duties he performs and the requisite level of air cleanness.
| | 第三十四条 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。
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Article 35 No person entering clean production areas should make up or wear ornaments.
| | 第三十五条 进入洁净生产区的人员不得化妆和佩带饰物。
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Article 36 Smoking, eating, drinking, and keeping food, drink, cigarettes, personal medicines and other articles for non-production use should all be prohibited in production and storage areas.
| | 第三十六条 生产区、仓储区应当禁止吸烟和饮食，禁止存放食品、饮料、香烟和个人用药品等非生产用物品。
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Article 37 An operator should not directly contact the pharmaceutical products, or packaging materials or the surface of equipment that comes into direct contact with pharmaceutical products with his bare hands.
| | 第三十七条 操作人员应当避免裸手直接接触药品、与药品直接接触的包装材料和设备表面。
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Chapter IV Premises and Facilities
| | 第四章 厂房与设施
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Section 1 Principle
| | 第一节 原 则
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Article 38 Premises must be located, designed, laid out, constructed, adapted, and maintained to suit the pharmaceutical production 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.
| | 第三十八条 厂房的选址、设计、布局、建造、改造和维护必须符合药品生产要求，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。
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Article 39 Premises should 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.
| | 第三十九条 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。
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Article 40 An enterprise should have a clean production environment. The surface of the ground and roads and the transportation of the plant area should not be a source of contamination of pharmaceutical products. The general lay-out of the production, administration, living and ancillary areas should be appropriately arranged and not block each other. The plants should be designed to ensure the logical flow of personnel and materials.
| | 第四十条 企业应当有整洁的生产环境；厂区的地面、路面及运输等不应当对药品的生产造成污染；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。
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Article 41 Premises should be carefully maintained, and it should be ensured that the repair and maintenance operations do not present any hazard to the quality of products. Premises should be cleaned and, where applicable, disinfected according to detailed written procedures.
| | 第四十一条 应当对厂房进行适当维护，并确保维修活动不影响药品的质量。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。
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Article 42 Lighting, temperature, humidity and ventilation in premises should be appropriate and such that they do not adversely affect, directly or indirectly, either the pharmaceutical products during their manufacture and storage, or the accurate functioning of equipment.
| | 第四十二条 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。
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Article 43 Premises and facilities should be designed and equipped in a way that can afford maximum protection against the entry of insects or other animals. Necessary actions should be taken to avoid the contamination of equipment, materials or products caused by raticide, pesticide, fumigant, etc.
| | 第四十三条 厂房、设施的设计和安装应当能够有效防止昆虫或其它动物进入。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。
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Article 44 Proper actions should be taken to prevent unauthorized people from entering the production, storage and quality control areas. Personnel who do not work in these areas should not use them as a passageway.
| | 第四十四条 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应当作为非本区工作人员的直接通道。
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Article 45 As-built drawings of built or rebuilt premises, services and restrained lines should be kept.
| | 第四十五条 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。
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Section 2 Production Areas
| | 第二节 生产区
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Article 46 In order to minimize the risks of contamination and cross-contamination, the premises, production facilities and equipment should be reasonably designed, laid out and used according to the features of the manufactured pharmaceutical products, sequence of the operations and the requisite cleanness levels and meet the following requirements:
| | 第四十六条 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药品的特性、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：
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1. The availability of premises, production facilities and equipment for the common use of different products should be determined by fully considering the features of pharmaceutical products, processes, intended use and other factors, and the corresponding evaluation reports should be provided;
| | （一）应当综合考虑药品的特性、工艺和预定用途等因素，确定厂房、生产设施和设备多产品共用的可行性，并有相应评估报告；
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2. Dedicated and separate premises, production facilities and equipment must be available for the production of particular pharmaceutical products, such as highly sensitizing drugs (e.g. penicillin) or biological preparations (e.g. BCG or the drugs produced by live microorganisms). In the operating areas of such drugs as penicillin where a large amount of dust is generated, a negative pressure should be maintained relative to other rooms. Before being discharged outside the room, the used steam (or air) should be cleaned so as to comply with the requirements. The opening for the discharge of used steam should be far away from the air intake of other air cleaning systems;
| | （二）生产特殊性质的药品，如高致敏性药品（如青霉素类）或生物制品（如卡介苗或其他用活性微生物制备而成的药品），必须采用专用和独立的厂房、生产设施和设备。青霉素类药品产尘量大的操作区域应当保持相对负压，排至室外的废气应当经过净化处理并符合要求，排风口应当远离其他空气净化系统的进风口；
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3. Drugs with the structure of β-lactam and contraceptive drugs of the sex hormone type must be manufactured with specialized facilities (e.g. a separate air cleaning system) and equipment, and the production area must be strictly separated from other production areas;
| | （三）生产β-内酰胺结构类药品、性激素类避孕药品必须使用专用设施（如独立的空气净化系统）和设备，并与其他药品生产区严格分开；
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4. Certain hormones, cytotoxic substances and highly active chemicals should be manufactured with dedicated facilities (e.g. a separate air cleaning system) and equipment. In exceptional cases, the principle of campaign working in the same production facilities and equipment can be accepted provided that specific precautions are taken and the necessary validations are made;
| | （四）生产某些激素类、细胞毒性类、高活性化学药品应当使用专用设施（如独立的空气净化系统）和设备；特殊情况下，如采取特别防护措施并经过必要的验证，上述药品制剂则可通过阶段性生产方式共用同一生产设施和设备；
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5. The used steam (or air) discharged from the air cleaning system as mentioned in the aforesaid subparagraphs 2, 3, and 4 should be cleaned; and
| | （五）用于上述第（二）、（三）、（四）项的空气净化系统，其排风应当经过净化处理；
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6. The manufacture of non-pharmaceutical products which may adversely affect the quality of pharmaceutical products should not be allowed in premises used for the manufacture of pharmaceutical products.
| | （六）药品生产厂房不得用于生产对药品质量有不利影响的非药用产品。
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Article 47 The adequacy of the production and storage space should permit the orderly and logical positioning of equipment, materials, intermediates, bulk 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.
| | 第四十七条 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、待包装产品和成品，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。
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Article 48 Production areas should be effectively ventilated with an air cleaning system including control of temperature and humidity and filtration of air, appropriate to the products handled, to the operations undertaken and to the external environment, so as to ensure that the environment for pharmaceutical production complies with the requirements.
The pressure differential between a clean area and a non-clean area, and between two clean areas of different levels should be at least 10 Pascal, and when necessary, there should be appropriate pressure differentials between different functional areas (rooms for operations) of the same cleanness level.
The areas for exposed stages of manufacturing of oral liquids and solid preparations, orifice medication (including rectum medication), epidermis topical drugs, and other non-sterile preparations and the areas for exposed stages of manufacturing of final treatment of primary packaging materials should be set up by reference to the requirements for Level-D clean areas as mentioned in the annex to “non-sterile drugs”, and the enterprise may take proper microorganism monitoring measures on such areas according to the criteria and features of products.
| | 第四十八条 应当根据药品品种、生产操作要求及外部环境状况等配置空调净化系统，使生产区有效通风，并有温度、湿度控制和空气净化过滤，保证药品的生产环境符合要求。
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。
口服液体和固体制剂、腔道用药（含直肠用药）、表皮外用药品等非无菌制剂生产的暴露工序区域及其直接接触药品的包装材料最终处理的暴露工序区域，应当参照“无菌药品”附录中D级洁净区的要求设置，企业可根据产品的标准和特性对该区域采取适当的微生物监控措施。
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Article 49 The interior surfaces (walls, floors and ceilings) of clean areas should be smooth and free from cracks and open joints, should not shed particulate matter, should have no dust and should permit easy and effective cleaning and, if necessary, disinfection.
| | 第四十九条 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。
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Article 50 Pipework, light fittings, ventilation points and other services should be designed and equipped to avoid the creation of recesses that are difficult to clean. As far as possible, for maintenance purposes, they should be accessible from outside the production areas.
| | 第五十条 各种管道、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。
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Article 51 Drains should be of adequate size and designed and equipped to prevent back-flow. Open channels should be avoided where possible, but if they are necessary they should be shallow to facilitate cleaning and disinfection.
| | 第五十一条 排水设施应当大小适宜，并安装防止倒灌的装置。应当尽可能避免明沟排水；不可避免时，明沟宜浅，以方便清洁和消毒。
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Article 52 The weighing of starting materials of preparations should be carried out in separate weighing areas designed for that purpose.
| | 第五十二条 制剂的原辅料称量通常应当在专门设计的称量室内进行。
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Article 53 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) should maintain a negative pressure relative to other rooms and special actions should be taken to prevent the dissemination of dust and cross-contamination and to facilitate cleaning.
| | 第五十三条 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。
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Article 54 Premises or areas for the packaging of pharmaceutical products should be reasonably designed and laid out so as to avoid mix-ups or cross-contamination. Separation measures should be taken if there are several packaging lines in the same area.
| | 第五十四条 用于药品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。
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Article 55 Production areas should be well lit, particularly where visual on-line controls are carried out.
| | 第五十五条 生产区应当有适度的照明，目视操作区域的照明应当满足操作要求。
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Article 56 An intermediate control area may be set up in a production area, but the intermediate control operations should not post any risk to the quality of pharmaceutical products.
| | 第五十六条 生产区内可设中间控制区域，但中间控制操作不得给药品带来质量风险。
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Section 3 Storage Areas
| | 第三节 仓储区
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Article 57 Storage areas should be of sufficient capacity to allow orderly storage of all kinds of materials and products: starting and packaging materials, intermediates, and bulk and finished products that are in quarantine, or released, rejected, returned or recalled.
| | 第五十七条 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、待包装产品和成品等各类物料和产品。
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Article 58 Storage areas should 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 should be met, and storage areas should be inspected and monitored.
| | 第五十八条 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。
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Article 59 Highly active materials or products and printed packaging materials should be stored in safe and secure areas.
| | 第五十九条 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。
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Article 60 Receiving and distribution and dispatch areas should protect materials and products from the impact of the weather (e.g. rain and snow). Receiving areas should be designed and equipped to allow containers of incoming materials to be cleaned if necessary before storage.
| | 第六十条 接收、发放和发运区域应当能够保护物料、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到货物料在进入仓储区前可对外包装进行必要的清洁。
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Article 61 Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access be restricted to allow only authorized personnel.
Segregation should be provided for the storage of rejected, returned or recalled materials or products.
Any system replacing the physical quarantine should give equivalent security.
| | 第六十一条 如采用单独的隔离区域贮存待验物料，待验区应当有醒目的标识，且只限于经批准的人员出入。
不合格、退货或召回的物料或产品应当隔离存放。
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。
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Article 62 There should normally be a separate sampling area for materials. The level of air cleanness of the sampling area should meet the requirements for production. If sampling is performed in other areas or in any other way, it should be conducted in such a way as to prevent contamination or cross-contamination.
| | 第六十二条 通常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。
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Section 4 Quality Control Areas
| | 第四节 质量控制区
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Article 63 Quality control laboratories should be separated from production areas. Areas where biological, microbiological or radioisotope test methods are employed should be separated from each other.
| | 第六十三条 质量控制实验室通常应当与生产区分开。生物检定、微生物和放射性同位素的实验室还应当彼此分开。
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Article 64 Quality control laboratories should be designed to suit the operations to be carried out in them, and avoid mix-ups and cross-contamination. There should be adequate space for disposing samples, retaining samples and storing samples for stability studies, and keeping records.
| | 第六十四条 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。
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Article 65 Where it is necessary, a separate room may be needed for instruments to protect highly sensitizing instruments against static interference, vibration, contact with excessive moisture or other external factors.
| | 第六十五条 必要时，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。
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Article 66 The laboratories handling biological samples, radioactive samples or other special articles should comply with the relevant requirements of the state.
| | 第六十六条 处理生物样品或放射性样品等特殊物品的实验室应当符合国家的有关要求。
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Article 67 Animal laboratories should be well isolated from other areas, and their design and construction should comply with the relevant provisions of the state, and they should have separate air-handling facilities and special passageway for animals.
| | 第六十七条 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，并设有独立的空气处理设施以及动物的专用通道。
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Section 5 Ancillary Areas
| | 第五节 辅助区
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Article 68 The setup of rest and refreshment rooms should not cause any adverse effects on the production, storage or quality control areas.
| | 第六十八条 休息室的设置不应当对生产区、仓储区和质量控制区造成不良影响。
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Article 69 The rooms for changing and storing clothes and for washing and toilet purposes should be easily accessible and appropriate for the number of users. Toilets should not communicate directly with production or storage areas.
| | 第六十九条 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。
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Article 70 Maintenance workshops should, if possible, be separated from production areas. Whenever parts and tools are stored in the clean area, they should be kept in rooms or lockers reserved for that purpose.
| | 第七十条 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。
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Chapter V Equipment
| | 第五章 设 备
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Section 1 Principle
| | 第一节 原 则
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Article 71 Equipment must be designed, selected, installed, adapted, and maintained to suit the operations to be carried out, and minimize the risks of contamination, cross-contamination, mix-ups and errors, permit easy operation, cleaning and maintenance and, if necessary, disinfection or sterilization.
| | 第七十一条 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。
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Article 72 There should be procedures for the usage, cleaning, maintenance and repair of equipment and the relevant operating records should be kept.
| | 第七十二条 应当建立设备使用、清洁、维护和维修的操作规程，并保存相应的操作记录。
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Article 73 The documents and records on the purchase, installation and qualification of equipment should be made and kept.
| | 第七十三条 应当建立并保存设备采购、安装、确认的文件和记录。
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Section 2 Design and Installation
| | 第二节 设计和安装
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Article 74 Production equipment should not present any hazard to the quality of pharmaceutical products. The surface of the production equipment that comes into contact with the product should be smooth, bright and clean, easy to clean or disinfect, anticorrosive, and must not be reactive, additive, or absorptive.
| | 第七十四条 生产设备不得对药品质量产生任何不利影响。与药品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，不得与药品发生化学反应、吸附药品或向药品中释放物质。
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Article 75 Weighing apparatus, measuring equipment, apparatus and meter of an appropriate range and precision should be available.
| | 第七十五条 应当配备有适当量程和精度的衡器、量具、仪器和仪表。
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Article 76 Appropriate washing and cleaning equipment should be chosen and used and be prevented from becoming a source of contamination.
| | 第七十六条 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。
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Article 77 The lubricants, coolants, etc. used for equipment should not contaminate pharmaceutical products or containers, and the lubricants of the edible level or an equivalent level should be used as far as possible.
| | 第七十七条 设备所用的润滑剂、冷却剂等不得对药品或容器造成污染，应当尽可能使用食用级或级别相当的润滑剂。
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Article 78 There should be procedures for the purchase, check and acceptance, safekeeping, maintenance, distribution and scrapping of moulds for production, and such moulds should be kept by designated persons in special areas, and be recorded.
| | 第七十八条 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。
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Section 3 Repair and Maintenance
| | 第三节 维护和维修
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Article 79 Equipment repair and maintenance operations should not present any hazard to the quality of products.
| | 第七十九条 设备的维护和维修不得影响产品质量。
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Article 80 There should be preventive maintenance programs and procedures, and equipment maintenance and repair operations should be recorded.
| | 第八十条 应当制定设备的预防性维护计划和操作规程，设备的维护和维修应当有相应的记录。
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Article 81 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.
| | 第八十一条 经改造或重大维修的设备应当进行再确认，符合要求后方可用于生产。
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Section 4 Use and Cleaning
| | 第四节 使用和清洁
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Article 82 There should be specific procedures for major production and testing equipment.
| | 第八十二条 主要生产和检验设备都应当有明确的操作规程。
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Article 83 Production equipment should be used within the confirmed scope of parameters.
| | 第八十三条 生产设备应当在确认的参数范围内使用。
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Article 84 Production equipment should be cleaned according to the detailed procedures.
The procedures for the cleaning of production equipment should describe specific and complete cleaning methods, equipment or tools for cleaning, name and preparation methods of detergents, methods for removing labels of the previous batch, methods for protecting the cleaned equipment from contamination before its usage, the maximum time limit for keeping the cleaned equipment, the methods for checking the cleanness of equipment before usage, so that the operators can clean all kinds of equipment in a repeatable and effective manner.
If the equipment needs to be dismantled and installed, the sequence and methods for dismantling and installing equipment should be prescribed; and if the equipment needs to be disinfected or sterilized, the specific methods for disinfection or sterilization, the name of detergents and the preparation methods should also be prescribed. When necessary, the maximum time limit permitted for equipment after production and before cleaning should be stated.
| | 第八十四条 应当按照详细规定的操作规程清洁生产设备。
生产设备清洁的操作规程应当规定具体而完整的清洁方法、清洁用设备或工具、清洁剂的名称和配制方法、去除前一批次标识的方法、保护已清洁设备在使用前免受污染的方法、已清洁设备最长的保存时限、使用前检查设备清洁状况的方法，使操作者能以可重现的、有效的方式对各类设备进行清洁。
如需拆装设备，还应当规定设备拆装的顺序和方法；如需对设备消毒或灭菌，还应当规定消毒或灭菌的具体方法、消毒剂的名称和配制方法。必要时，还应当规定设备生产结束至清洁前所允许的最长间隔时限。
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Article 85 The production equipment that has been cleaned should be stored under clean and dry conditions.
| | 第八十五条 已清洁的生产设备应当在清洁、干燥的条件下存放。
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Article 86 There should be a logbook on the equipment and apparatuses used for pharmaceutical production or testing, which should include the information on use, cleaning, repair and maintenance operations, and the date and time, the name, specification, batch number, etc. of pharmaceutical products produced and tested.
| | 第八十六条 用于药品生产或检验的设备和仪器，应当有使用日志，记录内容包括使用、清洁、维护和维修情况以及日期、时间、所生产及检验的药品名称、规格和批号等。
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Article 87 There should be an obvious status mark on production equipment to show the reference number of the equipment and contents (e.g. name, specification, batch number); and the cleanliness status should be labeled on the equipment if there are no contents.
| | 第八十七条 生产设备应当有明显的状态标识，标明设备编号和内容物（如名称、规格、批号）；没有内容物的应当标明清洁状态。
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Article 88 Defective equipment should be removed from production and quality control areas if possible, and before its removal, its status should be clearly labeled.
| | 第八十八条 不合格的设备如有可能应当搬出生产和质量控制区，未搬出前，应当有醒目的状态标识。
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Article 89 Main fixed pipework should be clearly labeled to indicate the contents and the direction of flow.
| | 第八十九条 主要固定管道应当标明内容物名称和流向。
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Section 5 Calibration
| | 第五节 校 准
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Article 90 Weighing apparatus, measuring equipment, instruments, and recording and control equipment and apparatuses for production and testing purposes should be periodically calibrated and inspected under the procedures and calibration plan, and the relevant records should be kept. The range of calibration should be suitable for actual production and testing.
| | 第九十条 应当按照操作规程和校准计划定期对生产和检验用衡器、量具、仪表、记录和控制设备以及仪器进行校准和检查，并保存相关记录。校准的量程范围应当涵盖实际生产和检验的使用范围。
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Article 91 Key weighing apparatus, measuring equipment, instruments, and recording and control equipment and apparatuses used for production and testing should be calibrated 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关键衡器、量具、仪表、记录和控制设备以及仪器经过校准，所得出的数据准确、可靠。
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Article 92 Calibration should be conducted by using the standard equipment for measuring in compliance with the relevant provisions of the state. The calibration records should indicate the name and reference number of the standard equipment for measuring, the expiry date of calibration, and the number of the measuring qualification certificate, so as to enable the records to be traced.
| | 第九十二条 应当使用计量标准器具进行校准，且所用计量标准器具应当符合国家有关规定。校准记录应当标明所用计量标准器具的名称、编号、校准有效期和计量合格证明编号，确保记录的可追溯性。
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Article 93 The weighing apparatus, measuring equipment, instrument and the equipment and apparatuses used for recording and control should 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，标明其校准有效期。
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Article 94 The weighing apparatus, measuring equipment and instrument, and the instrument and apparatuses used for recording and control that have not been calibrated, have exceeded the expiry date of calibration, or are out of standard should not be used.
| | 第九十四条 不得使用未经校准、超过校准有效期、失准的衡器、量具、仪表以及用于记录和控制的设备、仪器。
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Article 95 Automated or electronic equipment used in the course of production, packaging or storage should be calibrated and inspected on a regular basis under the procedures so as to ensure that they function correctly. The calibration and inspection should be recorded.
| | 第九十五条 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。
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Section 6 Water for Pharmaceutical Use
| | 第六节 制药用水
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Article 96 Water for pharmaceutical use should be suitable for its intended use, and meet the specifications and the relevant requirements of the Pharmacopoeia of the People's Republic of China. Such water should be at least drinking water.
| | 第九十六条 制药用水应当适合其用途，并符合《中华人民共和国药典》的质量标准及相关要求。制药用水至少应当采用饮用水。
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Article 97 The design, installment, operation and maintenance of water processing equipment and the transmission system thereof should ensure that the water for pharmaceutical use meets the defined specifications. The water processing equipment should not be operated beyond its designed capacity.
| | 第九十七条 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。
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Article 98 The materials used for storage tanks and transmission pipelines of purified water and water for injections should be innocuous and anti-corrosive. The hydrophobic bacterial filter with no fiber loss should be installed in the intake of storage tanks. Dead angle and blind pipe should be avoided in the design and installment of pipes.
| | 第九十八条 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。
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Article 99 Purified water and water for injections should be prepared, stored and distributed to prevent the growth of microorganisms. Purified water should be circulated, and the water for injections should be circulated at a temperature of 70℃ or above.
| | 第九十九条 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。
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Article 100 The quality of water for pharmaceutical use and raw water should be monitored on a regular basis and be recorded.
| | 第一百条 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。
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Article 101 The pipes of purified water and water for injections should 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 should be taken according to the procedures.
| | 第一百零一条 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。
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Chapter VI Materials and Products
| | 第六章 物料与产品
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Section 1 Principle
| | 第一节 原 则
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Article 102 The starting materials used in the manufacturing of pharmaceutical products and primary packaging materials should comply with the relevant specifications. The oil and ink used for directly printing words on the products should comply with the edible standards.
Imported starting materials should comply with the relevant provisions of the state on import administration.
| | 第一百零二条 药品生产所用的原辅料、与药品直接接触的包装材料应当符合相应的质量标准。药品上直接印字所用油墨应当符合食用标准要求。
进口原辅料应当符合国家相关的进口管理规定。
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Article 103 There should be procedures for materials and products, so as to ensure their correct receiving, storage, distribution, use and dispatch, and prevent contamination, cross-contamination, mix-ups and errors.
Materials and products should be handled under the procedures or master formula, and be recorded.
| | 第一百零三条 应当建立物料和产品的操作规程，确保物料和产品的正确接收、贮存、发放、使用和发运，防止污染、交叉污染、混淆和差错。
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。
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Article 104 Material suppliers should be determined and changed upon quality evaluation, and materials can only be purchased upon the approval of the quality management department.
| | 第一百零四条 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。
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Article 105 Materials and products should be transported in a way that their quality can be guaranteed, and the transportation conditions should be qualified in the case of any special requirement for transportation.
| | 第一百零五条 物料和产品的运输应当能够满足其保证质量的要求，对运输有特殊要求的，其运输条件应当予以确认。
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Article 106 There should be procedures for the receipt of each delivery of starting material and primary and printed packaging material, and all incoming materials should be checked to ensure that the consignment corresponds to the order, and the supplier has been approved by the quality management department.
Containers should be labeled with the prescribed information and be cleaned where necessary. Damage to containers and any other problem that might adversely affect the quality of a material should be reported to the quality management department and investigated and recorded.
The records of the receipt of each delivery should include:
| | 第一百零六条 原辅料、与药品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，以确保与订单一致，并确认供应商已经质量管理部门批准。
物料的外包装应当有标签，并注明规定的信息。必要时，还应当进行清洁，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。
每次接收均应当有记录，内容包括：
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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；
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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；
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3. the date of receipt;
| | （三）接收日期；
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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；
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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；
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6. the total quantity and number of containers received;
| | （六）接收总量和包装容器数量；
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7. the batch or serial number assigned by the enterprise after receipt; and
| | （七）接收后企业指定的批号或流水号；
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8. any relevant comment (e.g. state of the containers).
| | （八）有关说明（如包装状况）。
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Article 107 All incoming materials and finished products should be quarantined immediately after receipt or processing, until they are released.
| | 第一百零七条 物料接收和成品生产后应当及时按照待验管理，直至放行。
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Article 108 All materials and products should be stored according to their nature and in an orderly fashion to permit batch segregation, stock rotation, distribution and dispatch by a first-expire, first-out rule.
| | 第一百零八条 物料和产品应当根据其性质有序分批贮存和周转，发放及发运应当符合先进先出和近效期先出的原则。
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Article 109 If computerized storage systems are used for management, the relevant procedures should be available to prevent the mix-ups and errors of materials and products caused by system fault, halt, or any other special circumstance.
When fully validated computerized storage systems are used for identification, not all of the information on materials, products, etc. need be in a legible form on the label.
| | 第一百零九条 使用计算机化仓储管理的，应当有相应的操作规程，防止因系统故障、停机等特殊情况而造成物料和产品的混淆和差错。
使用完全计算机化仓储管理系统进行识别的，物料、产品等相关信息可不必以书面可读的方式标出。
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Section 2 Starting Materials
| | 第二节 原辅料
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Article 110 There should be the relevant procedures or appropriate measures of check, testing, etc. to ensure the identity of the contents of each container of starting material.
| | 第一百一十条 应当制定相应的操作规程，采取核对或检验等适当措施，确认每一包装内的原辅料正确无误。
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Article 111 If one delivery of material is made up of different batches, each batch must be considered as separate for sampling, testing and release.
| | 第一百一十一条 一次接收数个批次的物料，应当按批取样、检验、放行。
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Article 112 Starting materials in the storage area should be appropriately labeled. Labels should bear at least the following information:
| | 第一百一十二条 仓储区内的原辅料应当有适当的标识，并至少标明下述内容：
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1. the designated name of the material and the internal code reference;
| | （一）指定的物料名称和企业内部的物料代码；
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2. the batch number given by the enterprise on receipt;
| | （二）企业接收时设定的批号；
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3. the status of the contents (e.g. on quarantine, released, rejected, sampled); and
| | （三）物料质量状态（如待验、合格、不合格、已取样）；
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4. an expiry date or a retest date.
| | （四）有效期或复验期。
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Article 113 Only those starting materials released by the quality management department and within their shelf-life or retest period should be used.
| | 第一百一十三条 只有经质量管理部门批准放行并在有效期或复验期内的原辅料方可使用。
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Article 114 Starting materials should be stored within their shelf-life or retest period. A retest should be carried out in the case of any special circumstance which may adversely affect the quality during the storage period.
| | 第一百一十四条 原辅料应当按照有效期或复验期贮存。贮存期内，如发现对质量有不良影响的特殊情况，应当进行复验。
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Article 115 Starting materials should be dispensed only by designated persons according to the procedures, to ensure that the correct materials are accurately weighed or measured and properly labeled.
| | 第一百一十五条 应当由指定人员按照操作规程进行配料，核对物料后，精确称量或计量，并作好标识。
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Article 116 Each dispensed material and its weight or volume should be independently checked by another person and the check should be recorded.
| | 第一百一十六条 配制的每一物料及其重量或体积应当由他人独立进行复核，并有复核记录。
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Article 117 Materials dispensed for the same batch of pharmaceutical products should be kept together and conspicuously labeled as such.
| | 第一百一十七条 用于同一批药品生产的所有配料应当集中存放，并作好标识。
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Section 3 Intermediate and Bulk Products
| | 第三节 中间产品和待包装产品
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Article 118 Intermediate and bulk products should be stored under appropriate conditions.
| | 第一百一十八条 中间产品和待包装产品应当在适当的条件下贮存。
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Article 119 Intermediate and bulk products should have specific labels, which should at least indicate:
| | 第一百一十九条 中间产品和待包装产品应当有明确的标识，并至少标明下述内容：
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1. the name of the product and the internal code reference;
| | （一）产品名称和企业内部的产品代码；
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2. the batch number of the product;
| | （二）产品批号；
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3. quantity or weight (e.g. gross weight, net weight, etc.);
| | （三）数量或重量（如毛重、净重等）；
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4. stage of manufacturing (when necessary); and
| | （四）生产工序（必要时）；
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5. status of the product quality (when necessary, e.g. on quarantine, released, rejected, sampled).
．．．．．． | | （五）产品质量状态（必要时，如待验、合格、不合格、已取样）。
．．．．．． |
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