发布时间 : 星期一 文章New GMP ANVISA Regulation - RDC16 2013 - English Version(1)-对照译文更新完毕开始阅读
4.2.1.4 检查和测试的程序和验收标准，以及
4.2.1.4 Procedures for inspection and testing, with their acceptance criteria, and
4.2.1.5.安装、维护和维修的方法和程序。
4.2.1.5. Methods and procedures for installation, maintenance and servicing.
第5章——控制程序和生产流程
CHAPTER 5 - CONTROLS AND PRODUCTION PROCESS
5.1.一般说明
5.1. General Instructions
5.1.1.每个厂商应设计、执行、控制并监督所有生产流程，确保产品符合规范。由于制造流程的原因可能导致产品与规范产生偏差，厂商应建立并维护流程控制程序，说明必要的流程控制过程，确保产品符合规范。流程控制应包括：
5.1.1. Each manufacturer shall design, conduct, control and monitor all production processes to ensure that the product conforms to its specifications. Where can occur any deviation in the product specifications as a result of the manufacturing process, the manufacturer shall establish and maintain procedures to control process that describe any process controls necessary to ensure conformance to specifications. Process controls should include:
5.1.1.1.操作说明记录、定义和控制生产、安装和维护方式的标准操作程序和方法； 5.1.1.1. Documented instructions, standard operating procedures and methods that define and control the manner of production, installation and maintenance;
5.1.1.2.监督控制流程参数；
5.1.1.2. Monitoring and control of process parameters;
5.1.1.3.与技术标准、规范或参考标准的一致性，以及
5.1.1.3. Compliance with technical standards, codes or standards of reference, and
5.1.1.4.流程启动发布说明；
5.1.1.4. Instructions for process initiation release;
5.1.2.公司的设施必须经过适当的设计，确保能够进行所有操作和交换活动，或防止组成部分、生产材料、中间产品和成品受到污染，并保证以上各项的正确处理，包括配备充足的人员。
5.1.2. The company's facilities must be properly designed in order to provide the performance of all operations, exchanges or prevent contamination of components, manufacturing materials, intermediate and finished products and ensure proper handling of them, including adequate flow of people.
5.1.3.环境控制每个厂商应为生产流程提供合适的环境条件，防止产品污染或对产品产生其他不利影响。监控已有环境控制程序是否正确执行，并做相关记录。 5.1.3. Environmental Control. Each manufacturer shall provide suitable environmental conditions for production processes in order to prevent contamination or other adverse effects on the product. The correct functioning of the established environmental controls should be monitored, keeping the corresponding records.
5.1.3.1.清洁与消毒每个厂商应建立并维护适当的清洁和消毒程序，并制定满足制造流程规范要求的时间表。每个厂商应确保参与清洁和消毒的人员理解并掌握相关程序。
5.1.3.1. Cleaning and sanitizing. Each manufacturer shall establish and maintain appropriate procedures for cleaning and sanitizing, as well as a schedule that satisfies the requirements of the specifications of the manufacturing process. Each manufacturer shall ensure that personnel involved understand these procedures.
5.1.3.2.健康与个人卫生每个厂商应确保每个接触产品的员工或其他人员的穿着适合开展相应活动，保证员工的健康，并保持周围环境的清洁。如果在健康检查或监督观察中发现任何人员的健康状况可能会对产品产生影响，则上述人员应该停止操作，直至康复。每个厂商应指导员工向监督人员报告上述健康状况。
5.1.3.2. Health and personal hygiene. Each manufacturer shall ensure that employees and or others who are in contact with the product or your environment is clean, healthy and appropriately dressed for the activity to be performed. Any person who, by medical examination or supervisory observation, appearing to be at a health condition that may affect the product should be removed from operations until it is remedied. Each manufacturer shall instruct its staff to report such conditions to supervisors.
5.1.3.3.个人习惯每个厂商应在特定区域内限制食用食物和饮料，避免对生产区域造成影响。
5.1.3.3. Personal habits. Each manufacturer shall limit the consumption of food and drinks at specific locations so as not to affect the production areas.
5.1.3.4.污染控制每个厂商应建立并维护污染控制程序，防止对设备、组成部分、制造材料、中间产品和成品受到清洁和消毒的污染，包括制造过程中产生的有害物质或污染物。
5.1.3.4. Control of contamination. Each manufacturer shall establish and maintain procedures to prevent contamination of equipment, components, manufacturing materials, intermediate and finished products for cleaning and disinfecting materials, including hazardous substances or contaminants generated by the manufacturing process.
建立虫害控制程序，并且如果制造过程中使用了化学品，公司并需确保化学品不会对产品质量产生影响。
There should be a program of pest control and where chemicals are used, the company must ensure that they do not affect product quality.
5.1.3.5.垃圾清除与化学污物排放对于垃圾、化学废料和副产品的处理和处置应符合现有法律规定。
5.1.3.5. Trash removal and chemicals sewage. The treatment and disposal of waste, chemical waste and by-products shall occur in accordance with the current laws.
5.1.3.6.如果制造过程中存在生物风险，应遵守生物安全标准。
5.1.3.6. Biological safety standards should be observed in cases where there are biological risk.
5.1.4.员工职业健康每个厂商应确保遵守与员工职业健康相关的适用标准，包括员工根据工作流程的需要使用个人防护装备。
5.1.4. Worker occupational health. Each manufacturer shall ensure compliance with applicable standards related to the occupational health of workers, including the use of personal protective equipment for the same, which is consistent with the work processes performed.
5.1.5.设备每个厂商应确保制造过程中使用的所有设备都经过适当设计、建造和安装，符合预期用途，有利于设备的维护、调整、清洁和使用。
5.1.5. Equipment. Each manufacturer shall ensure that all equipment used in the manufacturing process are suitable for the intended use and properly designed, constructed and installed to facilitate maintenance, adjustments, cleaning and use.
5.1.5.1.维修计划每个厂商应建立并维护一份维修和调整计划，并在适当的情况下制定设备清洁计划，确保满足所有制造规范的要求。确保维护人员和设备使用人员能够轻易获得设备的维护程序。对设备的维护活动，包括实现日期和负责人的鉴定进行记录。
5.1.5.1. Maintenance schedule. Each manufacturer shall establish and maintain a schedule for maintenance, adjustments and, when appropriate, cleaning equipment, to ensure that all manufacturing specifications are being met. The maintenance program should be easily accessible to maintenance personnel and equipment use. Should be made a record of maintenance activities to the date of realization and identification of persons responsible.
5.1.5.2.调整每个厂商应确保在显眼的地方，或者需要定期调整的设备旁边张贴设备固有限制和可接受公差的相关信息，或者直接向相关负责人提供上述信息。 5.1.5.2. Adjustments. Each manufacturer shall ensure that any inherent limitations or acceptable tolerances are posted in a conspicuous place at or near the equipment requiring periodic adjustments or are readily available to the personnel in charge of these adjustments.
5.1.5.3.制造材料每个厂商必须建立并维护使用和清除制造材料的程序，确保上述材料从产品附近清除，或者将材料限制在特定数量，从而不会对产品产生不利影响。
5.1.5.3. Manufacturing materials. Each manufacturer must establish and maintain procedures for the use and removal manufacturing materials, to ensure that such materials be removed from the product or limited to a specified amount that does not adversely affect the quality of the product.
5.1.6.制造特殊流程应根据已有的程序和指导方针来执行，确保符合相关规范要求。产品历史记录中应记录产品的关键参数。
5.1.6. Special Processes shall be conducted in accordance with procedures and guidelines established to ensure conformance to specifications. Critical parameters should be monitored and recorded in the historical record of product.