东莞市2014-2015学年九年级上期末数学模拟试卷

_ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE东盟化妆品良好生产规范指南23Appendix VI ASEAN Guidelines for Cosmetic Good Manufacturing Practice 附录6 -东盟化妆品良好生产规范指南APPENDIX VI附录6ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE东盟化妆品良好生产规范指南PREAMBLE 序文The GMP Guidelines have been produced to offer assistance to the cosmetic industry in compliance with the provisions of the ASEAN cosmetic Directive. As this document is particularly intended for cosmetic products, clear delineation from drug or pharmaceutical product GMP should be kept in mind.已经有GMP指南为符合东盟化妆品指南规定的化妆品行业提供帮忙。由于本文专门用于化妆品，所以要谨记药品或药用物品GMP的清楚描述。The Good Manufacturing Practices presented here is only a general guideline for the manufacturers to develop its own internal quality management system and procedures. The important objective must be met in any case, i.e. the final products must meet the quality standards appropriate to their intended use to assure consumers health and benefit.这里介绍的良好生产规范只是为制造商提升内部质量管理系统和程序提供通用指南。任何情况下都要符合重要目标，例如成品必须达到符合它们的预期使用以确保消费者健康和利益的质量标准。1.INTRODUCTION 介绍The objective of the Cosmetic Good Manufacturing Practice ( GMP ) Guidelines is to ensure that products are consistently manufactured and controlled to the specified quality. It is concerned with all aspects of production and quality control. GMP指南的目标是确保如规定质量地一贯生产和控制产品。它涉及产品和质量控制的所有方面。1.1General Consideration 一般情况1.1.1In the manufacture of cosmetic products, overall control and monitoring is essential to ensure that the consumer receives products of high quality.在化妆品生产，为了让确保消费者获得高质量产品，必须全面控制和监控。1.1.2 The quality of a product depends on the starting materials, production and quality control processes, building, equipment and personnel involved.产品质量取决于起始原料、生产和质量控制过程、建立、设备和相关人员。1.2Quality Management System 质量管理系统1.2.1A quality system should be developed, established and implemented as a means by which stated policies and objectives will be achieved. It should define the organizational structure, functions, responsibilities, procedures, instructions, processesand resourcesfor implementingthe quality management. 应该发展、建立和实施质量系统，通过质量系统达到国家政策和目标。它应该规定组织结构、职能、职责、流程、说明、过程和对执行质量管理的资源。1.2.2The quality system should be structured and adapted to the companys activities and to the nature of its products and should take into consideration appropriate elements stated in this Guidelines. 质量系统应结构化并适用于公司活动和产品性质，以及考虑在本指南中提及的适合的基础。1.2.3 The quality system operation should ensure that if necessary, samples of starting materials, intermediate, and finished products are taken, tested to determine their release or rejection on the basis of test results and other available evidence related to quality.如有需要，检测起始原料、中间产品和成品的取样，从而根据检测结果和质量相关的其它有效证明来确定放行或拒绝它们。2.PERSONNEL 人员There should be an adequate number of personnel having knowledge, experience, skill and capabilities relevant to their assigned function. They should be in good health and capable of handling the duties assigned to them.必须有足够人员对分配的职责有相关的知识、经验、技能和能力。他们应该有良好的身体素质和能够处理分配给他们的职务。2.1Organization, Qualification and Responsibilities 组织、资格和责任2.1.1 The organizational structure of the company shall be such that the production and the quality control sections are headed by different persons, neither of whom shall be responsible to the other.公司的组织结构应该是这样的：生产和质量控制方面由不同的人负责，他们互不负责。2.1.2The head of production should be adequately trained and experienced in cosmetic manufacturing. He should have authority and responsibilities to manage production of products covering operations, equipment, production personnel, production areas and records. 生产负责人应该训练有素以及对化妆品生产有丰富经验。他有权利和责任去管理包括操作、设备、生产人员、生产区域和记录的产品生产。2.1.3The head of quality control should be adequately trained and experienced in the field of quality control. He should be given full authority and responsibility in all quality control duties such as establishment, verification and implementation of all qualitycontrolprocedures.He shouldhavetheauthority to designate/assign when appropriate, personnel, to approve starting materials, intermediates, bulk and finished products that meet the specification or to reject those which do not conform to the relevant specification or which were not manufactured in accordance with approved procedures and under the defined conditions.质量控制负责人应该训练有素和对质量控制方面有丰富经验。他应该授予全权，并负责全部质量控制职责，例如全部质量控制程序的建立、验证和执行等方面有全权和负责人。在适当的时候，他有权去指定/分配人员去批准符合规格的起始材料、中间产品、内容物和成品，拒绝不符合相关规范或不按已批准程序和给定条件而生产的起始材料、中间物、内容物和成品。2.1.4 The responsibilities and authority of key personnel should be clearly defined.应清楚地明确关键人员的责任和权利。2.1.5 An adequate number of trained personnel should be appointed to execute direct supervision in each section of the production and the quality control unit.应指定充足的训练有素的人员直接管理每个生产部分和质量控制部门。2.2Training 培训2.2.1All personnel directly involved in the manufacturing activities should be appropriately trained in manufacturing operations in accordance to GMP principles. Special attention should be given to training of personnel working with any hazardous materials. 所有直接参与生产活动的人员必须根据GMP细则经过生产操作的适当培训。应特别注意对工作涉及任何有害物质的人员的培训。2.2.2 Training in GMP should be conducted on a continuous basis.应持续地进行GMP培训。2.2.3 Records of training should be maintained and its effectiveness assessed periodically应保养培训记录并定期评估其有效性。3.PREMISES 前提The premises for manufacturing should be suitably located, designed, constructed and maintained. 应适当地定位、计划、构建和维护生产前提。3.1 Effective measures should be taken to avoid any contamination from the surrounding environment and from pests.应采取有效措施去避免任何来自环境和害虫的污染。3.2Household products containing non-hazardous materials/ingredients and cosmetic products can share the same premises and equipment provided that due care should be exercised to prevent cross contamination and risk of mix-up. 如果加强关注了实践预防交叉污染和混版的风险，含无害材料/配料的家居产品和化妆品可以共享相同的前提和设备。3.2 Painted line, plastic curtain and flexible barrier in the form of rope or tape may be employed to prevent mix-up.可以通过画线、塑料帘子、以及绳子或胶带形式的柔性护栏来防止混版。3.4Appropriate changing rooms and facilities should be provided. Toilets should be separated from the production areas to prevent product contamination/cross contamination. 要提供适当的更衣室和设施。为了防止生产污染和交叉污染，应分隔洗手间和生产区域。2.5 Defined areas should be provided for, wherever possible and applicable:任何可能的情况下，提供划定区域。3.5.1Materials receiving. 材料接收1.5.2Materials Sampling 材料取样1.5.3Incoming goods and quarantine. 来料和检验3.5.4Starting materials storage. 起始材料储存3.5.5Weighing and dispensing. 称重和分发3.5.6Processing. 加工3.5.7Storage of bulk products. 待加工产品的储存3.5.8Packaging. 包装3.5.9Quarantine storage before final release of products. 产品最终放行前的隔离储存3.5.10Storage of finished products. 成品储存3.5.11Loading and unloading. 装卸工作3.5.12Laboratories. 实验室3.5.13Equipment washing. 设备清洗3.6 Wall and ceiling, where applicable, should be smooth and easy to maintain. The floor in processing areas should have surface that is easy to clean and sanitise.在适用情况下，墙和天花板应平滑和易于维护。加工区域地板的表面应易于清洁和消毒。3.7 Drains should be of adequate size and should have trapped gullies and proper flow. Open channels should be avoided where possible, but if required they should be able to facilitate cleaning and disinfection.排水管应大小适中，有带气隔的沟壑和正常流量。尽量避免使用明渠，如需用到，应该便于清洁和消毒。3.8 Air intakes and exhausts and associated pipework and ducting, when applicable, should be installed in such a way as to avoid product contamination.在适用情况下，为了避免产品污染，应安装进风口和尾气以及相关管道工程和管道。3.9Buildings should be adequately lit and properly ventilated appropriate to the operations. 建筑物应有充足的照明和适合运作的通风。3.10Pipework, light fittings, ventilation points and other services in manufacturing areas should preferably be installed in such a way as to avoid uncleanable recesses and run outside the processing areas.在生产区域最好安装管道、照明装置、通风点和其他设施，以免不能清洁深处和加工运行区域。3.11Laboratories should preferably be physically separated from the production areas. 实验室最好和生产区域物理隔离。3.12Storage areas should be of adequate space provided with suitable lighting, arranged and equipped to allow dry, clean and orderly placement of stored materials and products. 储存区域应有足够空间，照明适中，有齐全的设施来干燥而干净地有序放置储存的材料和产品。3.12.1 Such areas should be suitable for effective separation of quarantined materials and products. Special and segregated areas should be available for storage of flammable and explosive substances, highly toxic substances, rejected and recalled materials or returned goods.应有区域适用于有效地分开隔离的材料和产品。特殊和隔离的区域应适用于储存易燃易爆物、剧毒物质、退料和回收的材料或退货。3.12.2 Where special storage conditions e.g. temperature, humidity and security are required, these should be provided.应提供特殊存储条件，例如温度、适度和安全是必需的。3.12.3 Storage arrangements should permit separation of different labels and other printed materials to avoid mix-up.储存安排应允许分离不同标签和其它印刷材料，以免混版。4.EQUIPMENT 设备Equipment should be designed and located to suit the production of the product.应设计和定位设备来适应产品生产。4.1Design and Construction 设计和施工4.1.1The equipment surfaces coming into contact with any in-process material should not react with or adsorb the materials being processed. 与任何生产中的材料接触的设备表面不能吸附生产中的材料或与其发生反应。4.1.2 Equipment should not adversely affect the product through leaking valves, lubricant drips and through inappropriate modifications or adaptations.设备不能通过泄漏阀门、润滑剂和通过不恰当的修改来对产品生产消极影响。4.1.3Equipment should be easily cleaned. 设备应易于清洗。4.1.3 Equipment used for flammable substances should be explosion proof.用于易燃物质的设备应表面防爆。4.2Installation and Location 安装和定位4.2.1 Equipment should be located to avoid congestion and should be properly identified to assure that products do not become admixed or confused with one another.为了避免拥挤和易于识别，应定位设备，从而确保产品不会混版。4.2.2Water, steam, and pressure or vacuum lines, where applicable, should be installed so as to be easily accessible during all phases of operation. They should be clearly identified. 在适用情况下，应该在操作的各阶段中安装容易获取的水、蒸汽、压强或真空管路。它们应该易于识别。4.2.2 Support systems such as heating, ventilation, air conditioning, water (such as potable, purified, distilled), steam, compressed air and gases (example nitrogen) should function as designed and identifiable.应设计可识别的支持系统，如加热、通风设备、空气调节、水（例如可饮用水、纯化水、蒸馏水）、蒸汽、压缩空气和气体(如氮)。4.3Maintenance 维护Weighing, measuring, testing and recording equipment should be serviced and calibrated regularly. All records should be maintained.应定期保养和校准称重、测量、测试和记录设备。应维护全部记录。5.SANITATION AND HYGIENE 清洁卫生Sanitation and hygiene should be practiced to avoid contamination of the manufacturing of products. It should cover personnel, premises, equipment/apparatus and production materials and containers.应保持清洁卫生，以免防产品生产污染。这包括人员、厂房、设备/仪器和生产材料和容器。5.1Personnel 人员5.1.1Personnel should be healthy to perform their assigned duties. Regular medical examination must be conducted for all production personnel involved with manufacturing processes. 人员应有良好的身体素质去执行分配的任务。应引导涉及生产过程的人员进行常规体检。5.1.2Personnel must pratise good personal hygiene. 人员应保持良好的个人卫生。5.1.3Any personnel shown at any time to have an apparent illness or open lesions that may adversely affect the quality of products should not be allowed to handle raw materials, packaging materials, in-process materials, and finished products. 任何人员患有可能不利产品质量的明显疾病或开放性创伤时，应该不允许他们处理原材料、包装材料、生产过程材料和成品。5.1.4Personnel should be instructed and encouraged to report to their immediate supervisor any conditions (plant, equipment or personnel) that they consider may adversely affect the products. 应教育和鼓励工作人员向直属上司报告他们认为不利于产品的情况（工厂、设备或人员）。5.1.5Direct physical contact with the product should be avoided to ensure protection of the product from contamination. Personnel should wear protective and clean attire appropriate to the duties they perform. 应避免身体直接接触产品，以确保产品防止污染。人员应穿戴防护和干净的衣着来执行他们的职责。5.1.6 Smoking, eating, drinking and chewing, food, drinks and smoking materials and other materials that might contaminate are not permitted in production, laboratory, storage or other areas where they might adversely affect product quality.在生产、实验室、仓库或其它可能影响产品质量的地方，应禁止吸烟、吃喝、咀嚼、食物、饮料、吸烟材料和其它可能引起污染的材料。5.1.7 All authorized personnel entering the production areas should practice personal hygiene including proper attire.所有授权进入生产区域的人员应注重包括适当着装的个人卫生。5.2Premises 前提5.2.1 Adequate employees washing and well ventilated toilet facilities should be provided and separated from the production area.应有足够人员进行清洁和洗手间设施通风良好，以及分开洗手间设施和生产区域。5.2.2 Suitable locker facilities should be provided at appropriate location for the storage of employees clothing and personal belongings.在适当的地方，为员工提供柜子装衣服和私人物品。5.2.3 Waste material should be regularly collected in suitable receptacles for removal to collection points outside the production area.在合适的收集点，定期收集废品，并清理到生产区域以外的收集点。5.2.4Rodenticides, insecticides, fumigating agents and sanitizing materials must not contaminate equipment, raw materials, packaging materials, in-process materials or finished products. 杀鼠剂、杀虫剂、熏蒸剂和消毒材料不能污染设备、原材料、包装材料、生产中用料或成品。5.3Equipment and Apparatus 设备和仪器5.3.1Equipment and utensils should be kept clean. 应保持设备和器具干净。5.3.2 Vacuum or wet cleaning methods are preferred. Compressed air and brushes should be used with care and avoided if possible, as they increase the risk of product contamination.首选真空或湿法净化方法。因为压缩空气和刷子可能增加产品污染的风险，应小心和尽量避免使用。5.3.3Standard operating procedures must be followed for cleaning and sanitizing of major machines. 应遵守标准操作程序来清洗和消毒主要机器。6.PRODUCTION 生产6.1Starting Materials 起始材料6.1.1Water 水 Special Attention should be paid to water, since it is an important raw material. Water production equipment and water systems should supply quality water. Water systems should be sanitized according to well- established procedures.因为水是重要的原材料，所以应特别重视。水生产设备和供水系统应提供高质量水。该根据完善的程序来消毒供水系统。The chemical and microbiological quality of water used in production should be monitored regularly, according to written procedures and any anomaly should be followed by corrective action.根据书面程序，定期监控用于生产的水的化学和微生物情况，以及出现异常时，采取纠正措施。The choice of method for water treatment such as deionisation, distillation or filtration depends on product requirement. The storage as well as delivery system should be properly maintained.根据产品要求，选择水处理的方法，例如去离子、蒸馏或过滤。应适当维护储存和运输系统。6.1.2Verification of materials 材料检验All deliveries of raw materials and packaging materials should be checked and verified for their conformity to specifications and be traceable to the product.应该检查和验证全部接收的原材料和包装材料，以便确认它们符合规格和产品追溯。Samples of raw materials should be physically checked for conformity to specifications prior to release for use. The raw materials should be clearly labeled. All goods must be clean and checked for appropriate protective packing to ensure no leakage, perforation or exposure.在放行使用之前，应物理检查原材料样品来确定它们是否符合规格。应对原材料贴标清晰。用作适当的防护包装，所有货物应该是干净的，经检测的，确保无泄漏，穿孔或爆裂。6.1.3Rejected materials 退料Deliveries of raw materials that do not comply with specification should be segregated and disposed according to standard operating procedures.应根据标准操作程序，隔离和处理接收的不合规格的原材料。 6.2Batch Numbering System 批号系统6.2.1Every finished product should bear a production identification number which enables the history of the product to be traced. 每个成品应有生产识别码，以便可以跟踪产品的生产情况。6.2.2A batch numbering system should be specific for the product and a particular batch number shall not be repeated for the same product in order to avoid confusion.批号系统对于产品来说，应该是特定的。独有的批号不能在同样的产品出现重复，以免混版。6.2.3 Whenever possible, the batch number should be printed on the immediate and outer container of the product.在任何可能的情况下，应即时在产品的外包装印刷产品批号。6.2.4 Records of batch number should be maintained.应维护批号的记录。6.3Weighing and Measurement 称重和测量6.3.1Weighing should be carried out in the defined areas using calibrated equipment. 应在划定区域，用校准的设备进行称重。6.3.2 All weighing and measurement carried out should be recorded and, where applicable, counterchecked.在适用情况下，应记录所有进行的称重和测量数据，并复查。 6.4Procedure and Processing 过程和处理6.4.1All starting materials used should be approved according to specifications. 根据规格，应批准所有起始材料。6.4.2All manufacturing procedures should be carried out according to written procedures. 根据书面程序，应执行全部生产程序。6.4.3All required in-process controls should be carried out and recorded. 应执行全部要求的生产控制，并记录。6.4.4Bulk products should be properly labeled until approved by Quality control, where applicable. 在适用情况下，应适当地标识待加工产品，直到得到质量控制的批准。6.4.5Particular attention should be paid to problem of cross-contamination in all stages of processing. 在整个生产过程中，特别注意交叉污染这一问题。6.5Dry Products 干货Handling of dry materials and products should be given special attention. Where possible, dust-containing production system, central vacuum system or other suitable methods should be employed.应特别注意干燥材料和产品的处理。在可能的情况下，应使用含尘生产系统、中央真空系统