Unified standards for bottled water in the pipeline

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关于瓶装水的15个小秘密

关于瓶装水的15个小秘密作者：来源：《时代英语·高一》2017年第04期Some of us get our water for free from the tap. The rest pay for it — at the cost of roughly $100 billion a year. At that steep a price tag， you might assume buying the bottled stuff would be worth it. In most cases， you'd be wrong. For the vast majority of Americans， a glass from the tap and a glass from the bottle are virtually identical as far as their health and nutritional quality are concerned. In some cases， publicly-sourced tap may actually be safer since it is usually tested more frequently.我们当中有些人从水龙头就能接到免费的水，其余的人要花钱买——每年大约花掉1000亿美元。

面对昂贵的价签，你可能会以为瓶装水值这个价钱。

但大部分情况下这个想法是错的。

对于大部分美国人来说，就对健康的影响和营养元素来说，自来水和瓶装水不相上下。

公共饮用水因为检测更频繁，所以有时可能更安全。

Read on to find out all the things you don’t know about your drinking water.读读下面的内容，了解一下关于饮用水你不知道的事。

1. The first documented case of bottled water being sold was in Boston in the 1760s， when a company called Jackson's Spa bottled and sold mineral water for “therapeutic” uses. Companies in Saratoga Springs and Albany also appear to have packaged and sold water.瓶装水最初在18世纪60年代开始出售，当时有一家叫Jackson's Spa的公司把矿物质水装瓶出售，说是“有益健康”。

矿泉水标准能力验证指南

矿泉水标准能力验证指南英文回答：Mineral water standard proficiency verification guidelines.Mineral water is a popular beverage choice for many people due to its perceived health benefits and refreshing taste. However, it is important to ensure that the mineral water we consume meets certain quality standards. Toachieve this, the mineral water industry has developed proficiency verification guidelines to assess the abilityof producers to meet these standards.The purpose of these guidelines is to ensure that mineral water producers adhere to specific quality control measures and maintain consistency in the production process. This helps to guarantee that the mineral water we consumeis safe, pure, and of high quality.One of the key aspects of the proficiency verification guidelines is the assessment of the mineral water'schemical composition. This involves analyzing the levels of various minerals present in the water, such as calcium, magnesium, and potassium. These minerals not onlycontribute to the taste and flavor of the water but also provide potential health benefits to consumers.For example, calcium is important for maintainingstrong bones and teeth, while magnesium plays a crucialrole in muscle function and energy production. By ensuring that the mineral water contains appropriate levels of these minerals, producers can offer a product that is not only refreshing but also beneficial to consumers' health.In addition to the chemical composition, theproficiency verification guidelines also evaluate the physical characteristics of the mineral water. Thisincludes assessing factors such as clarity, color, and odor. These characteristics can greatly impact the overallsensory experience of consuming mineral water.For instance, consumers expect mineral water to be clear and free from any suspended particles. Any deviation from this expectation may lead to a negative perception of the product's quality. Similarly, the color and odor of the water should be pleasant and inviting, as these factors can influence the initial impression consumers have of the product.Furthermore, the proficiency verification guidelines also emphasize the importance of proper labeling and packaging of mineral water. This ensures that consumers have access to accurate and relevant information about the product, such as its source, mineral content, andexpiration date.For example, a properly labeled mineral water bottle will clearly state the source of the water, whether it is from a natural spring or a purified source. It will also provide information about the mineral content, allowing consumers to make informed choices based on theirindividual preferences or health needs.In conclusion, the mineral water standard proficiency verification guidelines play a crucial role in ensuringthat the mineral water we consume meets specific quality standards. By assessing the chemical composition, physical characteristics, and proper labeling of the water,producers can offer a product that is both refreshing and beneficial to consumers' health. So, the next time youreach for a bottle of mineral water, you can haveconfidence knowing that it has undergone rigorous testingto meet these standards.中文回答：矿泉水标准能力验证指南。

国际饮用水安全评价

1饮用水安全评价的目的随着工业的发展，水污染日益严重，已对人类的生存安全构成重大威胁，成为人类健康、经济和社会可持续发展的重大障碍。

据世界卫生组织统计，全世界80%的疾病是由不安全的水和恶劣的环境卫生条件造成的，饮用不良水质导致的消化疾病、传染病、各种皮肤病、糖尿病、癌症、结石病、心血管病等多达50多种，1993年，在美国威斯康星洲爆发了大规模的由饮用水而产生的隐孢子虫病，导致40000人感染，100余人死亡[1]。

而目前我国对自来水的处理尚处于较低水平，仅能采用沉淀、过滤、加氯消毒等方法，将江河水或地下水简单加工成可饮用水。

自来水加氯可有效杀除病菌，同时也会产生较多的卤代烃化合物，这些含氯有机物的含量成倍增加，是引起人类患各种胃肠癌的最大根源。

而且受污染的水域中除重金属外，还含有甚多农药、化肥、洗涤剂等有害残留物，这些在水处理过程中都是无法去除的，即使是把自来水煮沸了，上述残留物仍驱之不去，还增加了有害物的浓度，降低了有益于人体健康的溶解氧的含量，因此，饮用开水的安全系数也是不高的。

要减少疾病、促进健康、拯救生命，最行之有效的措施就是使所有人获得良好的环境卫生和安全的饮用水。

鉴于我国饮用水处理技术水平尚低，必须加强对国际饮用水安全评价王硕,朱华平,柴志妮,谷传玲（食品营养与安全省部共建教育部重点实验室，天津科技大学食品工程与生物技术学院，天津300457）摘要：饮用水安全是全球共同关注的话题，世界各国均有专门部门进行饮水安全评价和相关规范标准的制定。

主要介绍世界先进国家饮用水安全标准以及健康风险评价的一般步骤，为饮用水管理机构的决策提供科学依据。

关键词：饮用水;安全标准;风险评价SAFETY ASSESSMENT OF THE INTERNATIONAL DRINKING-WATERWANG Shuo,ZHU Hua-ping,CHAI Zhi-ni,GU Chuan-ling（Key Laboratory of Food Nutrition and Safety,Ministry of Education,Tianjin University of Science &Technology,Tianjin300457,China）Abstract :The safety of drinking -water is a important topic in the world.There is a special department to evoluate the safety and lay down the relevant standards of drinking-water in each country over the world.This text mainly introduces the standards of drinking-water in advanced countries and also the general steps of health risk assessment,in order to provide a scientific basis of decision-making for water management agencies.Key words :drinking-water;safety standards;risk assessment作者简介：王硕，男(汉)，教授，博士生导师，研究方向：食品安全检测及风险评估。

安全水先行-实验用水的质量控制与管理-XXXX-3-8

Drafting Committee:
Merck Chemical, National Institute of Metrology (NIM), Shanghai Institute of Measurement and Testing Technology (SIMT)
仪器分析用高纯水的规格
Parameter
安全水先行 —实验
室用水质控与管理
实验室良好用水规范实验室用水---遵守“标准”和保证“安全”第一---该怎么做？
实验用水相关标准
标准的引领者
纯水应用实验案例
应用解决方案
实验用水的质量控制与管理
良好的纯水制备、使用及维
护习惯
实验室用水相关标准
—保障实验结果精确的前提
3
分析检测实验室用水遵循的标准
编制超纯水系统操作规程；良好的水质监控记录以及用水记录；按时进行维护和更换耗材，并记录；确保仪器运行正常，仪器出现报警
或提示信息时应及时处理；在一定情况下对内置仪表进行校准。
实验室水系统的质控需求
终端客户有三种做法可以实现对水机的质控要求
当地计量部门的检测
电导率仪的校准
实验室内自己检测
为确保实验用水水质的稳定性，应定期对水系统进行维护并按时更换耗材，并保存维护和耗材更换的记录。
良好的纯水制备、使用及维护
---纯
水达标的保障
什么是良好实验室纯水系统？
完备纯化流程
• RO/EDI技术确保水质稳定性
•耗用性纯化模块具备质量证书
全面精确监控
•满足国标要求的电导率监控
质、使用及维护应有效的预防污染的发生。 – 应定期监控和检验实验用水水质，确保水质符合不同等级用水的规格和指标。

雀巢天然矿泉水欧盟标准

雀巢天然矿泉水欧盟标准英文回答：Nestle Natural Mineral Water meets the standards set by the European Union (EU) for bottled water. These standards ensure that the water is safe for consumption and of high quality. The EU has strict regulations in place to protect consumers and maintain the integrity of the water supply.One of the requirements of the EU standards is that the water must be sourced from an underground water table or spring. This ensures that the water is naturally filtered and free from contaminants. Nestle Natural Mineral Water meets this requirement as it is sourced from natural springs.In addition to the source of the water, the EU standards also set limits on the levels of various substances that may be present in the water. These substances include minerals, heavy metals, andmicrobiological contaminants. Nestle Natural Mineral Water undergoes regular testing to ensure that it meets these standards and is safe for consumption.Furthermore, the EU standards also specify the labeling requirements for bottled water. This includes providing information about the source of the water, the mineral composition, and any treatments or processes that the water has undergone. Nestle Natural Mineral Water complies with these labeling requirements, providing consumers with transparent and accurate information about the product.Overall, Nestle Natural Mineral Water meets the EU standards for bottled water, ensuring that consumers can trust the quality and safety of the product.中文回答：雀巢天然矿泉水符合欧盟对瓶装水的标准。

水处理规范中英

生活饮用水水质处理器卫生安全与功能评价规范——一般水质处理器Sanitary Standard for Hygienic Safety and Function Evaluation on Treatment Devices of Drinking Water ——General Devices生活饮用水水质处理器卫生安全与功能评价规范——一般水质处理器Sanitary Standard for Hygienic Safety and Function Evaluation on Treatment Devices of Drinking Water ——General Devices１范围本规范规定了生活饮用水水质处理器的定义，与水接触材料的卫生要求，卫生安全性与功能性试验及出水水质要求。

本规范适用于以市政自来水或其他集中式供水为水源的家庭和集团用生活饮用水水质处理器。

生产纯水的生活饮用水水质处理器另作规定。

1 ScopeThis specification provides the definition of treatment devices of drinking water, sanitary requirements on materials in contact with water, hygienic safety and function test and requirements of water quality.This specification applies to municipal water or other centralized water supply for families and groups using treatment devices. The treatment devices that produce purified water are otherwise stipulated.２引用资料生活饮用水水质卫生规范（2001）生活饮用水检验方法规范（2001）生活饮用水输配水设备及防护材料卫生安全评价规范（2001）活性炭净水器（CJ 3023-93）2 Reference DataSanitary Standard for Drinking Water Quality (2001)Standard Examination Methods for Drinking Water (2001)Standard for Hygienic Safety Evaluation of Equipment and Protective Materials in Drinking Water (2001)Activated Carbon Water Filter (CJ 3023-93)３定义3.1生活饮用水水质处理器以市政自来水或其他集中式供水为原水，经过进一步处理，旨在改善饮水水质，去除水中某些有害物质为目的的饮用水水质处理器。

water for injection standard -回复

water for injection standard -回复"Water for Injection Standard: Ensuring Safety in Pharmaceutical Products"Introduction:Water for Injection (WFI) is a critical component in the pharmaceutical industry. It is widely used in the manufacturing, processing, and formulation of medicines, vaccines, and other healthcare products. As the name suggests, WFI is water that has been purified and treated to meet rigorous quality standards. In this article, we will delve into the WFI standard, its importance, and the steps involved in ensuring its safety.Importance of Water for Injection Standard:The quality of WFI has a direct impact on the safety, efficacy, and shelf life of pharmaceutical products. Contaminated or impure water can introduce harmful bacteria, endotoxins, or chemical impurities, which can compromise the integrity of medicinal products and pose a risk to patient health. Therefore, adherence to the WFI standard is of utmost importance to ensure the consistentand reliable production of pharmaceuticals.Step 1: Water Source Selection and Pretreatment:The first step in ensuring the quality of WFI is the selection of an appropriate water source. Common sources include municipal water supplies, underground wells, and natural springs. However, regardless of the source, the water must undergo pretreatment to remove potential contaminants. This pretreatment process often includes filtration, sedimentation, coagulation, and disinfection.Step 2: Reverse Osmosis:After pretreatment, the water is typically subjected to reverse osmosis (RO) to further purify it. RO involves passing the water through a semipermeable membrane, which removes dissolved solids, organic molecules, and microorganisms. This process is vital in achieving the desired level of purity for WFI.Step 3: Distillation:Following RO, the water is subjected to distillation, a process thatutilizes heat to vaporize the water and separate it from any impurities present. Distillation is highly effective in removing volatile substances, such as microorganisms, heavy metals, and non-volatile residues. Multiple distillation units, such assingle-effect or multiple-effect stills, may be used to achieve the desired level of purity.Step 4: Storage and Distribution:Once the water has been purified through distillation, it is collected and stored in a WFI storage system. This system is designed to maintain the water's integrity, preventing any potential recontamination. The storage vessels are constructed of materials that are resistant to corrosion and microbial growth. The water is then distributed to various points of use within the pharmaceutical facility through a system of sterile pipes and fittings.Step 5: Quality Control and Testing:Regular monitoring and testing of WFI are crucial to ensure its ongoing compliance with the established standards. This involves conducting regular microbial tests, endotoxin assays, conductivitymeasurements, and other relevant tests to verify the absence of impurities or deviations from the prescribed limits. Additionally, system performance tests, such as temperature mapping and pressure differentials, are conducted periodically to ensure the maintenance of system integrity.Conclusion:The WFI standard plays a pivotal role in ensuring the safety and efficacy of pharmaceutical products. Through a systematic approach involving water source selection, pretreatment, reverse osmosis, distillation, and quality control, the pharmaceutical industry can consistently generate high-quality WFI. Adherence to this standard is essential to minimize the risk of contamination and maintain the integrity of medicinal products, ultimately safeguarding patient health.。

国家饮用水标准(DOC)

国家饮用水标准(DOC)The latest standard for drinking water qualitynThis standard ___ GB5749-85 "Sanitary Standard for Drinking Water" from the date of ___ GB5749-85 are as follows:The water quality index has increased from 35 items to 106 items。

with an increase of 71 items and n of 8 items.Microbial indicators have increased from 2 items to 6 items。

including E。

coli。

thermotolerant coliforms。

Giardia and Cryptosporidium。

and n of total coliforms.Drinking water disinfectants have increased from 1 item to 4 items。

including chloramines。

ozone。

and chlorine xide.___ indicators have increased from 10 items to 21 items。

including bromates。

chlorites。

chlorates。

antimony。

barium。

beryllium。

boron。

molybdenum。

nickel。

thallium。

and cyanides。

and n of arsenic。

cadmium。

lead。

and nitrate.___ indicators have increased from 5 items to 53 items。

关于瓶装水操作的GMP检查清单

GMP CHECKLIST FOR BOTTLED WATER OPERATIONS
关于瓶装水操作的GMP检查清单
1.0SCOPE
范围
This specification includes the GMP checklist specifically deigned for bottle water operations.
这个说明书包括了关于瓶装水操作GMP详细的检查清单
2.0TABLE OF CONTENTS
内容目录
1.Scope
范围
2.Table of Contents
内容目录
3.“GMP Checklist for Bottled Water Operations”
关于瓶装水操作的GMP检查清单
The following checklist has been provided to assist in evaluating plant operations for GMP Compliance. The checklist is designed so that each question can be answered “yes” or “no”. The goal is to have all questions answered “yes”. Any “no” answers point out areas which need improvement.
下表用于厂家在生产时，其GMP是否与要求一致。

为方便计，该表把对问题的答案都设计成“是”与“否”。

目标应该全部都是“是”。

若有“否”，须指出需要改善的具体地方。

正常饮用水的标准指数

正常饮用水的标准指数Water quality standards are an essential aspect of ensuring safe and clean drinking water for the public. 正常饮用水的标准指数是保障公众饮用水安全和清洁的重要方面。

These standards provide a set of guidelines and regulations that determine the acceptable levels of various contaminants and impurities in drinking water. 这些标准提供了一套指导方针和法规，确定了饮用水中各种污染物和杂质的可接受水平。

They are designed to protect public health by ensuring that water used for drinking, cooking, and other domestic purposes meets certain quality criteria. 它们旨在通过确保用于饮用、烹饪和其他家庭用途的水满足一定的质量标准，以保护公共健康。

These standards are established and enforced by governmental organizations, such as the Environmental Protection Agency (EPA) in the United States and the Ministry of Environmental Protection in China. 这些标准由政府组织制定和执行，比如美国的环境保护署（EPA）和中国的环境保护部。

They are based on scientific research and data analysis that determine the potential health risks associated with exposure to specific contaminants in drinking water. 它们基于科学研究和数据分析，确定了饮用水中特定污染物暴露可能带来的健康风险。

关于推行瓶装液化石油气统一配送的建议函

关于推行瓶装液化石油气统一配送的建议函Dear Sir/Madam,I am writing to provide my suggestions regarding the implementation of centralized distribution for bottled liquefied petroleum gas (LPG).Firstly, it is important to recognize the various advantages that centralized distribution can bring. By establishing a unified system for delivering LPG, we can improve efficiency and reduce costs. The current fragmented distribution network often leads to duplication of resources and inefficient delivery routes. Centralized distribution would allow for optimized route planning, resulting in reduced transportation time and fuel consumption.Additionally, a centralized distribution system would enhance safety measures. With a single point of control, it becomes easier to regulate and monitor the quality of LPGbottles. This will ensure that only certified and properly maintained cylinders are being distributed to consumers. Furthermore, centralizing the storage and transport infrastructure would make it easier to implement strict safety standards across the entire supply chain.Moreover, adopting a unified approach to LPG distribution would promote environmental sustainability. By streamlining delivery routes, we can minimize carbon emissions associated with transportation. This aligns with our commitment to reducing greenhouse gas emissions and mitigating climate change concerns.In terms of implementation steps, collaboration among stakeholders is crucial. Government agencies should work closely with LPG suppliers, distributors, and retailers to develop a feasible plan for transitioning into centralized distribution. It is advisable to conduct a thorough feasibility study before implementing any changes to ensure that potential challenges are identified and addressed beforehand.Furthermore, public awareness campaigns are vital in garnering support from consumers and encouraging them to embrace this new system. Through informative campaigns, we can educate the public about the benefits of centralized distribution in terms of cost savings, safety enhancements, and environmental sustainability.To support the transition towards centralized distribution effectively, appropriate infrastructure investments must be made. This includes constructing storage facilities capable of accommodating large quantities of LPG cylinders as well as upgrading transportation fleets with more efficient vehicles.In conclusion, implementing centralized distribution for bottled liquefied petroleum gas is a necessary step towards achieving improved efficiency, enhanced safety, and environmental sustainability. By collaborating with all relevant stakeholders and investing in the necessary infrastructure, we can successfully transition into this system. Let us work together to make centralizeddistribution a reality.亲爱的先生/女士，我写信是为了提供关于推行瓶装液化石油气统一配送的建议。

拒绝瓶装水倡议书英语作文

拒绝瓶装水倡议书英语作文英文回答：Bottled Water: A Convenient Illusion.The ubiquitous presence of bottled water hasinfiltrated our lives, promising convenience and purity. However, beneath this alluring facade lies a deceptive truth that belies its environmental and financial repercussions.Environmental Degradation.Bottled water contributes significantly to plastic pollution. The production, transportation, and disposal of plastic bottles consume vast amounts of fossil fuels and resources. According to the Plastic Ocean Foundation, over 8 million tons of plastic waste end up in our oceans annually, where they threaten marine life and disrupt ecosystems. The recycling of plastic bottles is also achallenge, with only a small percentage being effectively recycled.Financial Burden.While bottled water is often marketed as a premium product, it is an unnecessary expense. Studies have shown that tap water is just as safe and clean as bottled waterin most developed countries. In fact, many bottled water brands simply repackage treated tap water, adding little to no additional value. The exorbitant price of bottled water, therefore, becomes a financial burden for consumers.Health Concerns.Bottled water may not be as pure as it claims. Contaminants such as BPA, a chemical linked to hormonal imbalances, can leach from the plastic bottles into the water. Moreover, the storage and transportation of bottled water can introduce additional risks of bacterial contamination.Alternatives to Bottled Water.The environmental and financial drawbacks of bottled water necessitate the adoption of sustainable alternatives. Reusable water bottles, made from materials such as stainless steel or BPA-free plastic, provide a convenient and cost-effective way to stay hydrated. Tap water, after proper filtration if necessary, is a safe and affordable option. Water dispensers can also be installed in homes and workplaces to provide accessible filtered water.Conclusion.The convenience of bottled water comes at a significant environmental and financial cost. As individuals and societies, we need to challenge the illusion of purity and embrace sustainable alternatives that protect our planet and our wallets. By opting for reusable bottles, tap water, or water dispensers, we can collectively reduce plastic waste, save money, and promote a healthier future.中文回答：瓶装水，一种便捷的假象。

ICHQa原料药GMP指南

Q7a（中英文对照）FDA原料药GMP指南Table of Contents目录1. INTRODUCTION 1. 简介1.1 Objective 1.1目的1.2 Regulatory Applicability 1.2法规的适用性1.3 Scope 1.3范围2. QUALITY MANAGEMENT 2.质量管理2.1 Principles 2.1总则2.2质量部门的责任2.2 Responsibilities of the QualityUnit(s)2.3生产作业的职责2.3 Responsibility for ProductionActivities2.4 Internal Audits (Self Inspection) 2.4内部审计（自检）2.5 Product Quality Review 2.5产品质量审核3. PERSONNEL 3. 人员3.1 Personnel Qualifications 3.人员的资质3.2 Personnel Hygiene 3.2 人员卫生3.3 Consultants 3.3 顾问4. BUILDINGS AND FACILITIES 4. 建筑与设施4.1 Design and Construction 4.1 设计与结构4.2 Utilities 4.2 公用设施4.3 Water 4.3 水4.4 Containment 4.4 限制4.5 Lighting 4.5 照明4.6 Sewage and Refuse 4.6 排污与垃圾4.7 Sanitation and Maintenance 4.7 卫生与保养5. PROCESS EQUIPMENT 5. 工艺设备5.1 Design and Construction 5.1 设计与结构5.2 Equipment Maintenance andCleaning5.2 设备保养与清洁5.3 Calibration 5.3 校验5.4 Computerized Systems 5.4 计算机控制系统6. DOCUMENTATION ANDRECORDS6. 文件与记录6.1 Documentation System andSpecifications6.1 文件系统与质量标准6.2 Equipment cleaning and UseRecord6.2 设备的清洁与使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials 6.3 原料、中间体、原料药的标签与包装材料的记录6.4 Master Production Instructions(Master Production and ControlRecords)6.4 生产工艺规程（主生产与控制记录）6.5 Batch Production Records(Batch Production and Control6.5 批生产记录（批生产与控制记录）Records)6.6 Laboratory Control Records 6.6 实验室控制记录6.7 Batch Production Record Review 6.7批生产记录审核7. MATERIALS MANAGEMENT7. 物料管理7.1 General Controls7.1 控制通则7.2 Receipt and Quarantine7.2接收与待验7.3 Sampling and Testing of7.3 进厂物料的取样与测试Incoming Production Materials7.4 Storage7.4储存7.5 Re-evaluation7.5复验8. 生产与过程控制8. PRODUCTION AND IN-PROCESSCONTROLS8.1 Production Operations8.1 生产操作8.2 Time Limits8.2 时限8.3 In-process Sampling and8.3 工序取样与控制Controls8.4 中间体或原料药的混批8.4 Blending Batches ofIntermediates or APIs8.5 Contamination Control8.5 污染控制9. 原料药与中间体的包装与贴签9. PACKAGING ANDIDENTIFICATION LABELING OFAPIs AND INTERMEDIATES9.1 General9.1 总则9.2 Packaging Materials9.2 包装材料9.3 Label Issuance and Control9.3 标签发放与控制9.4 包装与贴签操作9.4 Packaging and LabelingOperations10. STORAGE AND DISTRIBUTION10.储存与分发10.1 Warehousing Procedures10.1 入库程序10.2 Distribution Procedures10.2 分发程序11. LABORATORY CONTROLS11.实验室控制11.1 General Controls11.1 控制通则11.2 中间体与原料药的测试11.2 Testing of Intermediates andAPIs11.3 分析方法的验证11.3 Validation of AnalyticalProcedures11.4 Certificates of Analysis11.4 分析报告单11.5 Stability Monitoring of APIs11.5 原料药的稳定性监测11.6 Expiry and Retest Dating11.6 有效期与复验期11.7 Reserve/Retention Samples11.7 留样12. VALIDATION12.验证12.1 Validation Policy12.1 验证方针12.2 Validation Documentation12.2 验证文件12.3 Qualification12.3 确认12.4 Approaches to Process12.4 工艺验证的方法Validation12.5 Process Validation Program12.5 工艺验证的程序12.6 Periodic Review of ValidatedSystems12.6验证系统的定期审核12.7 Cleaning Validation12.7 清洗验证12.8 Validation of AnalyticalMethods12.8 分析方法的验证13. CHANGE CONTROL13.变更的控制14. REJECTION AND RE-USE OFMATERIALS14.拒收与物料的再利用14.1 Rejection14.1 拒收14.2 Reprocessing14.2 返工14.3 Reworking14.3 重新加工14.4 Recovery of Materials andSolvents14.4 物料与溶剂的回收14.5 Returns14.5 退货15. COMPLAINTS AND RECALLS15.投诉与召回16. CONTRACT MANUFACTURERS(INCLUDING LABORATORIES)16.协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 17.代理商、经纪人、贸易商、经销商、重新包装者与重新贴签者17.1 Applicability17.1适用性17.2 Traceability of Distributed APIs and Intermediates 17.2已分发的原料药与中间体的可追溯性17.3 Quality Management17.3质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates 17.4原料药与中间体的重新包装、重新贴签与待检17.5 Stability17.5稳定性17.6 Transfer of Information17.6 信息的传达17.7 Handling of Complaints andRecalls17.7 投诉与召回的处理17.8 Handling of Returns17.8 退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation 18. 用细胞繁殖/发酵生产的原料药的特殊指南18.1 General18.1 总则18.2 Cell Bank Maintenance andRecord Keeping18.2细胞库的维护与记录的保存18.3 Cell Culture/Fermentation18.3细胞繁殖/发酵18.4 Harvesting, Isolation andPurification18.4收取、分离与精制18.5 Viral Removal/Inactivationsteps18.5 病毒的去除/灭活步骤19. APIs for Use in Clinical Trials19. 用于临床研究的原料药19.1 General19.1 总则19.2 Quality19.2 质量19.3 Equipment and Facilities19.3 设备与设施19.4 Control of Raw Materials19.4 原料的控制19.5 Production19.5 生产19.6 Validation19.6 验证19.7 Changes19.7 变更19.8 Laboratory Controls19.8 实验室控制19.9 Documentation19.9 文件20. Glossary20. 术语Q7a GMP Guidance for APIsQ7a原料药的GMP指南1. INTRODUCTION 1. 简介1.1 Objective 1.1目的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）提供有关优良药品生产管理规范（GMP）提供指南。

要提供瓶装水的函范文

要提供瓶装水的函范文英文回答：Bottled Water Proposal.Introduction.As a reliable and effective way to address the growing demand for safe and convenient drinking water, bottled water has become increasingly popular around the world. This proposal outlines the benefits, challenges, and recommendations associated with the provision of bottled water, providing a comprehensive approach to meet current and future water needs.Benefits of Bottled Water.Convenience: Bottled water offers unmatched convenience, allowing individuals to access clean water on the go or in places where tap water is unavailable orunsafe.Safety: Rigorous purification and filtration processes ensure that bottled water meets the highest safety standards, eliminating contaminants and bacteria that can pose health risks.Quality: Bottled water undergoes stringent quality control measures, resulting in a consistent and refreshing taste that is preferred by many consumers.Accessibility: Bottled water is widely available in a variety of sizes and formats, making it easy forindividuals to access safe and clean drinking water regardless of their location.Challenges of Bottled Water.Environmental Concerns: The production and disposal of plastic bottles have raised environmental concerns, with large numbers of bottles ending up in landfills and waterways.Cost: Bottled water can be significantly more expensive than tap water, posing a financial burden for some individuals and communities.Sustainability: The reliance on non-renewable resources for plastic bottles raises questions about the long-term sustainability of bottled water production.Recommendations.To maximize the benefits of bottled water while addressing the challenges, the following recommendations are proposed:Promote Reusable Bottles: Encourage the use of reusable water bottles to reduce plastic waste and promote environmental conservation.Enhance Recycling Infrastructure: Improve recycling programs and establish dedicated facilities to ensure that plastic bottles are properly disposed of and recycled.Explore Sustainable Packaging: Invest in research and development of biodegradable or recyclable packaging materials to minimize the environmental impact of bottled water.Educate Consumers: Raise awareness about the environmental and economic implications of bottled water consumption, encouraging responsible use and disposal practices.Support Sustainable Water Sources: Explore alternative sources of water, such as purified rainwater or desalination, to reduce dependence on non-renewable groundwater resources.Conclusion.By implementing these recommendations, we can harness the benefits of bottled water while mitigating its challenges. By addressing concerns related to environmental impact, accessibility, and sustainability, we can ensurethat bottled water continues to play a vital role inmeeting the growing demand for safe and convenient drinking water worldwide.中文回答：瓶装水函范文。

瓶装饮用纯净水卫生标准

瓶装饮用纯净水卫生标准（中华人民共和国标准GB 17321-1998）hygienic standard of bottled purified water for drinking１范围本标准规定了瓶装饮用纯净水的定义、卫生要求及检验方法。

本标准适用于瓶装饮用纯净水。

２引用标准下列标准所包含的条文，通过在本标准中引用而构成为本标准的条文。

本标准出版时，所示版本均为有效。

所有标准都会被修订，使用本标准的各方应探讨使用下列标准最新版本的可能性。

GB 4789.2-94 食品卫生微生物学检验菌落总数的测定GB 4789.3-94 食品卫生微生物学检验大肠菌群的测定GB 4789.4-94 食品卫生微生物学检验沙门氏菌检验GB 4789.5-94 食品卫生微生物学检验志贺氏菌检验GB 4789.10-94 食品卫生微生物学检验葡萄球菌检验GB 4789.11-94 食品卫生微生物学检验溶血性链球菌检验GB 4789.15-94 食品卫生微生物学检验霉菌和酵母菌检验GB 5749-85 生活饮用水卫生标准GB 5750-85 生活饮用水卫生标准检验方法GB 7718-94 食品标签通用标准GB/T 8538-1995 饮用天然矿泉水检验方法GB 14881-94 食品企业通用卫生规范GB 17323-1998 瓶装饮用纯净水３定义本标准采用下列定义。

瓶装饮用纯净水bottled purified water for drinking以符合生活饮用水卫生标准的水为原料，通过电渗析法、离子交换法、反渗透法、蒸馏法及其他适当的加工方法制得的，密封于容器中且不含任何添加物可直接饮用的水。

４卫生要求4.1 原料用水：应符合GB 5749的规定4.2 感官指标感官指标应符合表１的规定。

表１感官指标4.3 理化指标4.3.1 PH值、电导率、市锰酸钾消耗量、氯化物等指标应符合GB 17323规定。

表２质量理化指标4.3.2 污染理化指标应符合表3规定。

water for injection standard

water for injection standardWater for Injection Standard: Ensuring Quality and SafetyIntroduction:Water for Injection (WFI) is a crucial component in the pharmaceutical industry, used in various processes such as the preparation of parenteral products, cleaning of equipment, and the production of drug formulations. As WFI is intended for administration via injection, its quality and safety are of utmost importance. This article will dive into the topic of WFI standards, discussing its definition, production, regulatory requirements, and quality control measures.Definition and Production:Water for Injection is highly purified water that meets specific quality standards. It is different from other forms of water used in pharmaceutical manufacturing, such as purified water or water for irrigation. WFI must be free from impurities, toxins, microorganisms, and pyrogens.WFI is produced through different methods, such as distillation, reverse osmosis, or a combination of both. Distillation involves heating the water to the boiling point, vaporizing it, and then condensing the steam to obtain highly purified water. Reverse osmosis, on the other hand, uses a semipermeable membrane to remove impurities and contaminants. Both methods are effective in producing WFI.Regulatory Requirements:The production and quality of WFI are controlled by various regulatory authorities, including the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and other national or regional pharmacopoeias. These regulatory authorities publish guidelines and standards that must be followed by pharmaceutical manufacturers to ensure the quality and safety of WFI.For example, the USP monograph for WFI sets forth specific requirements related to chemical purity, microbial contamination, and pyrogenicity. It defines the maximum allowable levels of impurities, such as heavy metals, oxidizable substances, and specific ions. Additionally, it prescribes microbial limits andendotoxin limits, as well as the specifications for various tests that must be performed to confirm compliance.Quality Control Measures:To ensure the quality and safety of WFI, rigorous quality control measures are implemented throughout its production and storage. These measures include:1. Raw Material Evaluation: The source water used for the production of WFI is evaluated to ensure it meets the necessary requirements for chemical and microbiological purity. Regular testing and monitoring of source water quality are essential.2. Validation of Manufacturing Processes: The production processes, whether distillation or reverse osmosis, must be validated to ensure consistently high-quality WFI. Parameters such as temperature, pressure, flow rate, and duration of processes are closely monitored and controlled.3. Microbial Monitoring: WFI is subjected to regular microbiological testing to detect the presence of microorganisms. Testing methodssuch as membrane filtration or the pour plate method are employed to quantify the microbial load accurately.4. Endotoxin Testing: Endotoxins, which are substances derived from the cell walls of certain bacteria, must be eliminated from WFI, as they can cause adverse reactions in patients. Testing for endotoxin levels is typically performed using the Limulus Amebocyte Lysate (LAL) test, a sensitive assay that detects the presence of endotoxins.5. Packaging and Storage: Proper packaging and storage conditions are crucial to maintaining the quality of WFI. Sterile packaging materials, such as glass or plastic containers, are used to prevent contamination during storage. The storage area must have controlled temperature and humidity levels to ensure the stability of WFI.Conclusion:Water for Injection is a critical component in the pharmaceutical industry, and its quality and safety are tightly regulated to protectpatient health. Compliance with regulatory requirements, implementation of quality control measures, and adherence to validated production processes are essential to ensure the production of high-quality WFI. By maintaining these standards, pharmaceutical manufacturers can provide healthcare professionals and patients with a reliable source of pure and safe water for injections.。

中华人民共和国国家标准生活饮用水标准检验方法微生物指标

中华人民共和国国家标准生活饮用水标准检验方法微生物指标Standard examination methods for drinking water一Microbioloical parameters1、菌落总数1.1平皿计数法1.1.1范围本标准规定了用平皿计数法测定生活饮用水及其水源水中的菌落总数本法适用于生活饮用水及其水源水中菌落总数的测定。

1.1.2术语和定义下列术语和定义适用于本标准。

1.1.2.1菌落总数standard plate - count加cteria水样在营养琼脂上有氧条件下37℃培养48h后，所得1ml水样所含菌落的总数1.1.3培养基与试剂1.1.3.1营养琼脂1.1.3.1.1成分：A 蛋白陈10gB 牛肉膏3gC 氯化钠5gD 琼脂10g——20gE 蒸馏水1000ml1.3.1.2制法：将上述成分混合后，加热溶解，调整pH 为7.4一7.6，分装于玻璃容器中（如用含杂质较多的琼脂时，应先过滤），经103.43 kPa (121℃，15lb）灭菌20 min，储存于冷暗处备用。

1.1.4仪器1.1.4.1高压蒸汽灭菌器。

1.1.4.2干热灭菌箱。

1.1.4.3培养箱36℃士2℃。

1.1.4.4电炉。

1.1.4.5天平。

1.1.4.6冰箱。

1.1.4.7放大镜或菌落计数器。

1.1.4.8 pH计或精密pH试纸。

1.1.4.9灭菌试管、平皿（直径9cm）、刻度吸管、采样瓶等1.1.5检验步骤1.1.5.1生活饮用水1.1.5.1.1门以无菌操作方法用灭菌吸管吸取1mL充分混匀的水样，注人灭菌平皿中，倾注约15mL已融化并冷却到45℃左右的营养琼脂培养基，并立即旋摇平皿，使水样与培养基充分混匀每次检验时应做一平行接种，同时另用一个平皿只倾注营养琼脂培养基作为空白对照1.1.5.1.2待冷却凝固后，翻转平皿，使底面向上，置于36℃士1℃培养箱内培养48h，进行菌落计数，即为水样1 ml中的菌落总数1.1.5.2水源水1.1.5.2.1以无菌操作方法吸取lml充分混匀的水样，注入盛有9ml、灭菌生理盐水的试管中，混匀成1 : 10稀释液。

Small_Things_Create_Big_Waves

32CHINA TODAY“Convenient facilities and relatively stable incomes are making our life increasingly promising,” enthused Yangjen Lhamo, who lives in Naxingtang Community, Nagqu City, Tibet Autonomous Region. She believes that her children’s life will be better.The 47-year-old woman has eight children. Her eldest son has been working in her community after graduating from the Qamdo Vocational and Technical School, her eldest daughter works at a sweet tea house in the city, and the rest of the children study at middle schools or universities in Tibet and Gansu Province.Relocating for New LifeNaxingtang Community in Nagqu Town, Seni District, is a resettlement site for poverty allevia-tion and relocation. The community covers an area of more than 60,000 square meters and its 30 buildings house 2,003 relocated people. The reloca-tion was completed in 2019, involving 12 towns in Seni District.Before being relocated, Yangjen, from a rural area, rented a house in the city and worked to raise her children. Due to the early death of her hus-band, although eight children’s food, housing, and tuition are provided by schools for free, life was still difficult for the family. After the implementa-By staff reporter LI GUOWENWith the help of governments at all levels, farmers and herdsmen in Tibet can now continually keep up with the progress of the times and social development through their own efforts.tion of the relocation project, the Seni District government relocated 455 needy households to Naxingtang Community and provided 90-120 square meters of housing free of charge according to the size of each family.After the relocation, her family continued to enjoy subsidies for rural residents from the gov-Small ThingsCreate Big WavesSpecial ReportTwenty-five-year-old Chimed Dorje is a worker in the Naxingtang Com-munity, Nagqu City, Tibet Autono-mous Region.33January 2024ernment. “Our annual net income has increased from RMB 30,000 to RMB 70,000 now,” said her 25-year-old eldest son Chimed Dorje, who is look-ing forward to his younger siblings being admitted into universities and being able to find good jobs in Lhasa.Recalling life in the village when he was a child, he described how rammed earth and stone houses were not very stable. Water, electricity, washing and sanitation, and Internet access were not as convenient as they are now, and there was no heating in winter. Now, as a fan of music, he often uploads songs he sings onto TikTok to share his life with others.Talking about the employment and income sources of the relocatedhouseholds, Tsering Chozom,the head of the NaxingtangCommunity, said that the community received fundsfrom the district government,and implemented two sup-porting projects to achievepoverty alleviation, one is through industrial devel-opment and the other is a holiday resort. Through an employment demand survey, the community helped more than 50 people who had employment difficulties to land jobs in the holiday resort. At the same time, residents can also obtain income by selling their ethnic handicrafts.Helping turn people’s lives around, the poverty alleviation relocation program has shown mo-mentum and vitality. According to Tsering, the relocated farmers and herdsmen are living in new houses and enjoying a good life. With the help of local governments, they have been able to share the benefits of social, economic and technological progress.“Relocation is the approach we are pursuing, and employment is the basic need we are satisfy-ing in order to reach the goal of helping the people become financially stable,” said Zhou Qingke, head of the Publicity Department of the Nagqu Munici-pal Party Committee. “Developing the collective economy through poverty alleviation projects is one of the methods we utilize to help relocated farmers and herdsmen integrate into urban life.” For a long time, Tibet’s road out of poverty had been hindered by the fact that the area was very vast with a sparse population and costs of poverty reduction were high. At the end of 2015, the pover-ty incidence in Tibet was 19.62 percentage points higher than that of the whole country, and the region as a whole was in a state of deep poverty. “Ending poverty and never letting it be passed on from one generation to the next!” This has become the consensus of the more than three million people in Tibet. Government depart-ments at all levels have adapted measures to local conditions, implemented policies in differ-ent categories, and adopted the most effective strategies and the most targetted methods to carry out relocation for the purpose of poverty alleviation. During the 13th Five-Year Plan pe-riod (2016-2020), there were 628,000 registered poor people in the region, of which 266,000, or 42 percent, were lifted out of poverty as a result of the relocation policy. Relocation has proved to be effective in reducing poverty and promotingsustainable development.Helping turn people’s lives around, the poverty alleviation relocationprogram has shown momentum and vitality.An ethnic danceperformed at the cultural square of the Naxingtang Community.34CHINA TODAYSpecial ReportHelping Rural RevitalizationWalking into a textile cooperative in Konglang Village, Dana Town, Xigaze, the sound of weaving could be heard coming from the workshop inside. In the exhibition room, all kinds of Tibetan wool clothes and blankets made of traditional crafts are on display. Their exquisite workmanship and unique charm are very impressive.Sonam, the 43-year-old head of the coopera-tive, is a skilled weaver and award winner at the first National Farmers’ Skills Competition, which was held in Liaocheng, Shandong Province in July, 2023. "I competed with more than 300 players selected from more than 3,000 registered partici-pants across the country. It was an eye-opening experience for me. After a full day of competitions, my carefully woven cow-head ornament won third prize in the hand-knitting finals,” said Sonam.Established in May 2019 with a total investment of RMB 2.3 million from 11 families, the coopera-tive currently has 25 employees. So far, Sonam hastrained more than 130 women in five townships in the skill of weaving. After completing the train-ing, each trainee is provided with a set of weaving equipment and tools by the cooperative free of charge. This helps locals find employment and in-crease their income through weaving contracting.In 2023, the cooperative’s sales reached RMB 450,000 with a net profit of RMB 300,000. The cooperative takes out part of its annual profits to support the livelihood undertakings in the village, contributing to rural revitalization.According to Tashi Tsering, Party secretary of Dana Township, it takes about 25 days to weave a set of Tibetan-style blankets based on the com-plexity of their patterns, and the cooperative pays RMB 6,000-8,500 for each set. At present, residents of Konglang Village produce about 180 sets of wo-ven products for the cooperative annually, earning RMB 1.3 million or more.Tenzin Chodron, a worker at the cooperative, has been learning the skill of carpet weaving forRelocation has proved to be effective in reducing poverty and promoting sustainable deve-lopment.RELOCATIONLocals are busy weaving at a farm-ers’ professional cooperative in Kong-lang Village, Dana Township, Xigaze.35January 2024that exhibit local culture.Different from the coop-erative in Konglang Village,the cooperative for breeding, processing, and sales of live-stock products in Qubu Vil-lage, Nagqu City, is more like a collectively-owned enterprise,and all the business activitiesof the villagers are carried outunder the unified manage-ment of this enterprise.Founded in 2010, the cooperative in Qubu Vil-lage is owned by every family, each of whom has invested in it with their livestock, pasture, and labor. At the beginning of its establishment, the per capita annual income of the villagers was only RMB 1,800, and the annual income of the village collective was RMB 46,000. Over the past 10 years, the cooperative has launched various types of in-dustrial entities, such as fattening bases, livestock breeding, ethnic clothing processing, dairy produc-tion, and teahouses. As a result per capita annualincome has risen to RMB 18,000 and the collec-tive’s revenues exceeded RMB 5.35 million.Karma Chonyi, who works as a cook in a teahouse run by the cooperative, enjoys his life very much. “I can earn salary with my cooking skills by working in the teahouse and get dividends from the cooperative at the end of the year. This has made my life much better than it was before,” he said. In 2022, Karma’s family received more than RMB 40,000 in cash dividends from the coopera-tive.According to the cooperative director Tsewang Tashi, cooperatives play a leading role in improv-ing rural lives, connecting local people with the market.Specialized cooperatives have changed the mode of production and management of farm-ers and herders, and improved their production enthusiasm and efficiency. According to the De-partment of Agriculture and Rural Affairs of Tibet Autonomous Region, as of June 2023, there were 11,980 registered rural cooperatives in the region, including 138 national-level demonstration coop-eratives and 118 autonomous region-level dem-three years. “You can weave as long as you have time, and farmers can weave at night during busy farming season,” said Tenzin, who has an income of RMB 2,000-3,000 per month. She can also make money at home while taking care of her children.Located in the southeast of Namling County with an average altitude of 4,100 meters, Dana Township is home to 2,992 farmers and herders in four administrative villages. During the past few years, the township government has mobilized local entrepreneurs to establish cooperatives to promote employment and increase income for vil-lagers. “Since 2019, our township has established 28 cooperatives in the fields of weaving, Tibetan furniture, aquaculture, bottled water, and ma-chinery leasing,” Tashi said, “There are five weav-ing cooperatives in the township, and the annual income from weaving business reaches RMB 6.65 million, accounting for 12 percent of the township economy.”An ancient skill has created an industry and improved the lives of local people. In recent years, the Namling County government of Xigaze has promoted local characteristic industries, given full play to the leading role of entrepreneurs like So-nam, and guided villagers in developing industriesSpecialized cooperativeshave changed the mode of production and manage-ment of farmers and herd-ers, and improved theirproduction enthusiasmand efficiency.Forty-three-year-old Sonam is askilled weaver andaward winner at the first NationalFarmers’ SkillsCompetition.36CHINA TODAYonstration cooperatives. In 2022, about 1.2 million farmers and herders had joined cooperatives in the region.Small Things MatterTibet is located at a high altitude with low air pressure. Most pressure cookers sold on the market are designed for plain areas, making them unable to meet the cooking needs of the plateau people.In February 2022, the regional government orga-nized relevant professional institutions and six leading cookware enterprises to set up a technical research team to develop a pot suitable for the people living on the plateau.After more than 20 technical discussions and research improvements, more than 30 kinds of plateau kitchenware products, such as multi-func-tional cookware, steamers, kettles, and outdoor products were launched. Tibet Shangchu Cook-ware Technology Co., Ltd. started operation in Lhasa Economic and Technological Development Zone on November 20, 2022, and has created anannual output of one million plateau special pressure cook-ware. Plateau cookware wasput on the market in Lhasa on January 17, 2023, and was warmly welcomed by localpeople.The autonomous region implemented a plan to sup-port the promotion and appli-cation of plateau kitchenware products on March 25, 2023. To be specific, the autono-mous region gives a subsidy of RMB 300 to each rural household and low-income urban household and RMB 200 to each urban household to purchase plateau cookware.According to Cai Shuailong, general manager of Tibet Shangchu Cookware Technology Co., Ltd., the government subsidizes the purchase of 12L plateau pressure cooker. It purchases them from the company for RMB 400, and local people only need to spend RMB 100 to buy one at various rural promotional stores. Today, the sales of 12L pressure cookers has reached 350,000.Dorje Yapei, a villager from Konglang Village who bought the pressure cooker a few months ago, said that pressure cookers he used in the past took a long time to heat up, boil, and decom-press. This new pressure cooker has different settings for cooking different foods, making it easy to operate. The pressure is auto-matically released after pushing a button.Choosing a suitable and durable cooker is a small fam-ily thing, but all the small things that make up people’s ordinary life are regarded by the govern-ment as major matters of people’s livelihood, which constitute the core of a people-centered devel-opment strategy.CChoosing a suitable and durable cooker is a smallfamily thing, but all thesmall things that make uppeople’s ordinary life are regarded by the govern-ment as major matters ofpeople’s livelihood.An assembly lineof Tibet Shangchu Cookware Technol-ogy Co., Ltd.Special Report。