Quality Standards for Melanoma
Quality standardization (质量标准综述)
Quality standardizationBackgroundStandardization is the process of developing and implementing technical standards andvital in creating and sustaining quality，which can help to maximize compatibility, interoperability, safety, repeatability. And then also facilitate commoditization of formerly custom processes.Standards are applied to many materials (e.g. paint), products (e.g. hair dryers), methods (e.g. wiring a house), and services (e.g. travel information). They simplify aspects of our lives and increase the reliability and the effectiveness of the goods and services we use.Quality is the extent to which a user’s needs and expectations are met. To protect our consumers, establishing ‘fitness for purpose’is crucial for many products e.g. a medical dressing.In China a level of quality is achieved by an organization’s compliance with an acceptable standard for the product, and also compliance with another standard for the organization’s effective quality management system that ensures consistent achievement throughout its production processes.Quality standardization was firstformed in the Industrial Revolution, and then became highly important in different aspects. In 1800, Henry Maudslay developed screw-cutting lathe, which allowed for the standardization of screw thread sizes for the first time. This was a major advance in workshop technology.CategoryNowtodays, quality standardization had grouped two groups. First one: national quality standardization,it was widely adopted in other countries. Such as Joseph Whitworth’s screw thread measurements were adopted as the first (unofficial) national standard by companies around the country in 1841. In that time, some companies' in-house standards spread a bit within their industries.The national standards were adopted universally throughout the country, and enabled the marketsto act more rationally and efficiently, with an increased level of cooperation.The world's first national standards body is Engineering Standards Committee, which as established in London in 1901. And then became the British Engineering Standards Association in 1918 with extended its standardization work. In 1931, it was adopted the name British Standards Institution after receiving its Royal Charter in 1929. similar national bodies were established in other countries after the First World War, such as The DeutschesInstitutfürNormung, the American National Standard Institute and the French Commission Permanente de Standardisation.Second one: international quality standardization, it was widely adopted in all over world. For example, in the early 20th century, the large range of different standards and systems used by electrical engineering companies. Many companies had entered the market in the 1890s and all chose their own settings for voltage, frequency, current and even the symbols used on circuit diagrams.Crompton could see the lack of efficiency in this system and began to consider proposals for an international standard for electric engineering.By 1906 his work was complete and he drew up a permanent constitution for the first international standards organization, the International Electrotechnical Commission.In general, each country or economy has a single recognized National Standards Body (NSB). Examples include ABNT, AENOR, AFNOR, ANSI, BSI, DGN likely the sole member from that economy in ISO.BenefitsQuality standardization relate both to products and to management systems. Everyone benefits from standard setting and their benefits are inter-related. Standards create clarity and certainty and remove confusion. It lead to businesses become key beneficiaries. Because it helps businesses to be commercially viable. Standardized products and parts reduce design, production, warehousing and distribution costs. It is reassuring. Consumers know they can believe the claims that producers make forthem, which conform to certain standards in order to be put on sale. And then it is protective and helps businesses to be cost effective and time efficient. Meanwhile, quality standardizationcan be used asfact standards which means they are followed by informal convention or dominant usage. As jure standards which are part of legally binding contracts, laws or regulations. As voluntary standards which are published and available for people to consider for use.SafetyMain mission of setting of quality standardization is to make sure consumer safety. For example, opening wine bottles safely has become a higher priority. so BGMChelped to create a set of guidelines for the design of a cork removal device for wine bottles. It make sure that the operation can be carried out safely. In addition, several standards for the manufacture of different glass bottles were established.Under UK legislation, standards are a good way for manufacturers to comply with European Union Directives, such as the Directive for electrical equipment.ReferenceWang Ping (2011), A Brief History of Standards and Standardization Organizations: A Chinese Perspective, east-west center working papers.BSI Group Annual Report and Financial Statements 2010. p. 2. Retrieved 3 April 2012.McWilliam., Robert C. (2001). BSI: The first hundred years. London: Thanet. Lindley, David (2005). Degrees Kelvin: A Tale of Genius, Invention, and Tragedy. National Academic Press. p. 293.Colonel Crompton. (2010). International Electrotechnical Commission.Johnson, J.; Randell, W. (1948). Colonel Crompton and the Evolution of the Electrical Industry. Longman Green.Dyer, Chris K.; Moseley, Patrick T.; Ogumi, Zempachi; Rand, David A. J.; Scrosati, Bruno (2010). Encyclopedia of Electrochemical Power Sources. Newnes. p. 540.Report of Preliminary Meeting. (2014) The minutes from our first meeting. London: International Electrotechnical Commission. 1906. pp. 46-47.Friendship among equals - Recollections from ISO's first fifty years. International Organization for Standardization. 1997. pp. 15-18.Moreno, Juan A. (2009). Interoperabiltyand Standardization within NATO. NATO Standards Agency.Shapiro, Carl; Hal R. Varian (1999). Information Rules: A Strategic Guide to the Network Economy. Boston, Mass: Harvard Business School Press. pp. 232–233.Christensen, Clayton M.; Michael E. Raynor (2003). The Innovator's Solution: Creating and Sustaining Successful Growth. Boston, Mass: Harvard Business School Press. p. 140.Shapiro, Carl; Hal R. Varian (1999). Information Rules: A Strategic Guide to the Network Economy. Boston, Mass: Harvard Business School Press. p. 264. Christensen, Clayton M.; Michael E. Raynor (2003). The Innovator's Solution: Creating and Sustaining Successful Growth. Boston, Mass: Harvard Business School Press. pp. 131-132.Shapiro, Carl; Hal R. Varian (1999). Information Rules: A Strategic Guide to the Network Economy. Boston, Mass: Harvard Business School Press. p. 231. Cowan, Robin. High Technology and the Economics of Standardization. Paper presented at the International Conference on Social and Institutional Factors Shaping Technological Development: Technology at the Outset, Berlin, Germany, May 27-28, 1991.。
国外产品检测标准
国外产品检测标准In today's globalized market, the issue of product testing standards for foreign goods has become increasingly important. As consumers become more conscious of the quality and safety of the products they purchase, it has become essential for countries to establish proper regulations and standards for testing foreign products before they can be sold to the public. This helps to ensure that consumers are protected from potentially harmful or substandard products that may not meet the same quality standards as domestically produced goods.在当今全球化的市场中，对于国外商品的产品检测标准问题日益重要。
随着消费者对他们购买的产品的质量和安全意识逐渐增强，各国有必要制定适当的法规和标准，以确保在向公众销售之前对国外产品进行测试。
这有助于确保消费者免受可能有害或不合格产品的影响，而这些产品可能不符合国内生产商品的质量标准。
One of the key reasons for establishing product testing standards for foreign goods is to protect public health and safety. By ensuring that imported products meet the same safety and quality standards asdomestically produced goods, countries can prevent the sale of potentially harmful or dangerous products to consumers. This not only helps to protect consumers from health risks but also maintains the reputation of the country as a safe and reliable market for goods.建立国外商品的产品测试标准的一个关键原因是为了保护公众健康和安全。
美国FDA食品生产企业GMP
美国FDA食品生产企业GMP（良好操作规范）法规时间:2005-12-06 14:50:00 来源:食品商务网A 总则§110.3定义联邦食品、药物及化妆品法（以下简称该法案）第210节中术语的定义和解释适用于本法规的同类术语，下列定义亦同样适用：（a）酸性食品或酸化食品（Acid foods or acidified foods）：平衡pH值等于或低于4.6的食品。
（b）适当的（Adequate）为完成良好公共卫生规范的预定目标所需要的要求。
（c）面糊（Batter）：一种半流体物质，通常包含面粉和其它成分。
可在其中浸蘸食品的主要成分，或用它涂在外表，或直接用它制成焙烤食品。
（d）烫漂（Blanching）：在包装前对食品（不包括树生坚果和花生）进行热处理，使天然酶部分或完全失活，并使该食品发生物理或生化的变化。
（e）关键控制点（Critical control point）：食品加工过程中的一个点，若该点控制不当，极可能造成、引发或导致危害，或导致成品污染，或导致成品分解。
（f）食品（Food）：指210法案（f）节所定义的食品，包括各种原料和配料。
（g）食品接触面（Food contact surfaces）：接触食品的那些表面以及经常在正常加工过程中会将污水滴溅在食品上或溅在接触食品的那些表面上的表面。
“食品接触面”包括用具及接触食品的设备表面。
（h）批（Lot）：在某一时间段内生产的用具体编号标记的食品。
（i）微生物（Microorganisms）：酵母菌、霉菌、细菌和病毒，并包括但不限于对公众健康产生影响的那些微生物种类。
“不良微生物（undesirable microorganisms）”包括那些对公众健康产生显著影响的微生物，会使食品分解的微生物，会使食品受到杂质污染的微生物，或使食品成为该法案所指的掺杂食品的微生物。
在某些情况下，美国FDA在这些法规中使用形容词“微生物的（microbial）”，替代包含“微生物（microorganism）”的形容词短语。
乳糖酸欧洲标准-概述说明以及解释
乳糖酸欧洲标准-概述说明以及解释1.引言1.1 概述乳糖酸欧洲标准是与乳糖酸相关的产品在欧洲地区制定的一套标准和规范。
乳糖酸是一种重要的有机酸，在食品、医药、化工等诸多领域有着广泛的应用。
欧洲标准的制定旨在确保乳糖酸产品的质量和安全，并促进乳糖酸产品在欧洲市场的流通和交易。
乳糖酸欧洲标准的制定背景具有多方面的考虑因素。
首先，随着全球贸易的发展和国际市场的竞争，国际贸易标准化已经成为各国重要的议题之一。
欧洲作为全球最大的乳糖酸消费市场之一，对于乳糖酸产品的标准化有着迫切的需求。
其次，乳糖酸产品的使用范围广泛，包括食品添加剂、药物成分、工业原料等，因此关系到公众的健康安全和企业的生产质量。
此外，不同国家和地区对于乳糖酸产品的质量要求和规定各不相同，亟需建立一套统一的标准，以促进乳糖酸行业的健康发展和国际合作。
乳糖酸欧洲标准的内容涵盖了乳糖酸产品的生产、储存、包装、运输等全过程的要求和规范。
其中包括对乳糖酸产品的物理化学性质、安全性、纯度、标签标识等方面的规定，以确保乳糖酸产品的质量和安全。
同时，标准还对乳糖酸产品的检测方法、质量控制、环境保护等方面提出了要求，以推动乳糖酸行业的科学发展和可持续发展。
乳糖酸欧洲标准的应用和意义不仅限于欧洲地区，也对其他地区和国家的乳糖酸产品行业具有重要影响。
一方面，乳糖酸欧洲标准的实施可以提升欧洲地区乳糖酸产品的质量和竞争力，促进欧洲乳糖酸行业的发展。
另一方面，欧洲标准的制定可以为其他国家和地区提供一个参考和借鉴的标杆，帮助其建立和完善乳糖酸产品的标准体系，推动全球乳糖酸行业的协同发展。
总之，乳糖酸欧洲标准的制定是为了确保乳糖酸产品的质量和安全，促进乳糖酸行业的发展和合作。
它不仅是欧洲地区乳糖酸行业的重要参考，也具有全球范围内的推动作用。
相信通过乳糖酸欧洲标准的实施，乳糖酸产品的质量和安全将得到有效保障，为消费者提供更加安全、健康的产品。
同时，标准的建立也将推动乳糖酸行业的创新发展和可持续发展。
Chapter 8 Quality Management 工业工程专业英语 教学课件
9. Key Elements of Six Sigma Methodology
The key elements of Six Sigma are:
Customer Satisfaction Defining Processes Defining Metrics and Measures for Processes Using and Understanding Data and Systems Setting Goals for Improvement Team Building and Involving Employees
➢ Make sure you begin the process with the right attitude. ➢ Have a complete understanding of the concept set forth
in the standard, and use the standard as a guide template to define your management system.
Obtain a standard Review literature and software Assemble a team and define your strategy Determine training needs Review consultant options Develop a management systems manual Develop procedures Implement your management system Consider a pre-assessment Select a certification body/registrar
生物制品中 唾液酸残留标准
生物制品中唾液酸残留标准英文回答：Sialic acid is a naturally occurring compound found in many biological products, including human saliva. It is commonly used as a marker for evaluating the quality and safety of these products. The residual level of sialic acid is an important parameter that needs to be monitored and controlled to ensure product quality.In the field of biopharmaceuticals, there are specific standards and regulations set by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the allowable residual level of sialic acid in biological products. These standards vary depending on the type of product and its intended use.For example, in the case of therapeutic proteins derived from mammalian cell cultures, the FDA hasestablished a limit of 10 µg of sialic acid per mg of protein as an acceptable level. This limit ensures that the product is free from excessive sialic acid, which can potentially affect its safety and efficacy.To comply with these standards, biopharmaceutical manufacturers employ various purification and analytical techniques to remove or reduce the level of sialic acid in their products. These techniques include chromatography, filtration, and enzymatic treatments. By implementing these processes, manufacturers can effectively control the residual level of sialic acid and ensure product quality.In addition to regulatory standards, individual companies may also have their own internal specifications for sialic acid residues in their products. These specifications are often more stringent than regulatory requirements and are based on the company's own research and development efforts.中文回答：唾液酸是一种自然存在的化合物，存在于许多生物制品中，包括人类的唾液中。
美国药品生产质量管理规范-中英文对照
GOOD MANUFACTURE PRACTICE 美国药品生产质量管理规范（CGMP）二○○三年十二月目录210.1 cGMP法规的地位 (2)210.2 cGMP法规的适用性 (2)210.3 定义 (2)211-A- 总则 (4)211-B- 组织与人员 (4)211-C- 厂房和设施 (5)211-D- 设备 (7)211-E- 成份、药品容器和密封件的控制 (8)211-F- 生产和加工控制 (10)211-G- 包装和标签控制 (11)211-H- 贮存和销售 (13)211-I- 实验室控制 (14)211-J- 记录和报告 (16)211-K- 退回的药品和回收处理 (20)210部分—人用及兽用药品的生产、加工、包装或贮存的CGMPPart 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL210.1 cGMP法规的地位§ 210.1 Status of current good manufacturing practice regulations.(a) 在本部分及21CFR 211—226部分中陈述的法规是在药品生产、加工、包装或贮存中使用的现行生产质量管理规范及使用的设施或控制的最低标准，以保证该药品符合联邦食品、药品及化妆品法对安全性的要求，具有均一性和效价(或含量)并符合或代表其生产过程的质量及纯度等特征。
(a) The regulations set forth in this part and in Parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.(b) 凡是在药品生产、加工、包装或贮存过程中存在任何不符合本部分及21CFR 211—226部分中陈述的法规的药品，依据联邦食品、药品及化妆品法501 (a)(2)-(B)，该药应被视为劣药，同时导致该事故发生的负责人应受相应的法规的制裁。
东盟化妆品良好生产规范指南中英版本
__________________________________________________________________________ ASEAN GUIDELINES FOR COSMETIC GOODMANUFACTURING PRACTICE东盟化妆品良好生产规范指南Appendix VI–ASEAN Guidelines for Cosmetic GoodManufacturing Practice附录6 -东盟化妆品良好生产规范指南APPENDIXVI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 qualityst andards appropriate to their intended use to assure consumer’s 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。
食品和食品标准的英文名称
食品和食品标准的英文名称糖、可可制品、巧克力及其它制品标准名称蜂蜜标准Standard for Honey可可脂标准Standard for Cocoa Butters巧克力标准Standard for Chocolate可可粉和可可糖混合物标准Standard for Cocoa Powders (Cocoas) and Dry Cocoa-sugar Mixtures天然矿泉水标准Standard for Natural Mineral Waters加工可可和巧克力制品所使用的碎可可豆, 可可块, 可可油饼和可可细粉标准Standard for Cocoa (Cacao) Nib, Cocoa (Cacao) Mass, Cocoa Press Cake and Cocoa Dust (Cocoa Fines), for Use in the Manufacture of Cocoa and Chocolate Products夹心巧克力成分标准Standard for Composite and Filled Chocolate可可脂糖果标准Standard for Cocoa Butter Confectionery木薯标准Standard for Gari食醋标准Standard for Vinegar蛋黄酱标准Standard for Mayonnaise食用木薯粉标准Standard for Edible Cassava Flour糖标准Standard for Sugars鱼和鱼制品标准名称沙文鱼罐头Canned Salmon速冻除内脏及带内脏鳍鱼Quick Frozen Finfish, Uneviscerated and Eviscerated小虾或大虾罐头Canned Shrimps or Prawns金枪鱼和鲣鱼罐头Canned Tuna and Bonito蟹肉罐头Canned Crab Meat速冻小虾或大虾Quick Frozen Shrimps or Prawns沙丁鱼和沙丁类鱼制品罐头Canned Sardines and Sardine-Type Pro油脂和相关制品标准名称单个标准未涉及的食用油脂通用标准General Standard for Edible Fats and Oils Not Covered by Individual Standards人造奶油标准(脂肪含量不低于80%) Standard for Margarine粗制和精炼的橄榄油, 以及精炼橄榄渣油标准Standard for Olive Oil, Virgin and Refined, and for Refined Olive-Pomace Oil人造奶油标准(脂肪含量在39%-41%间) Standard for Minarine命名植物油标准Standard for Named Vegetable Oils命名动物油标准Standard for Named Animal Fats谷物、豆类及其制品以及植物蛋白标准名称面粉标准Standard for Wheat Flour玉米标准Standard for Maize (Corn)整玉米粗粉标准Standard for Whole Maize (Corn) Meal脱胚玉米粉和玉米渣标准Standard for Degermed Maize (Corn) Meal and Maize (Corn) Grits 小麦面筋标准Standard for Wheat Gluten脱皮的整珍珠小米标准Standard for Whole and Decorticated Pearl Millet Grains小米面标准Standard for Pearl Millet Flour某些豆类标准Standard for Certain Pulses高粱米标准Standard for Sorghum Grains高粱面标准Standard for Sorghum Flour植物蛋白制品标准General Standard for Vegetable Protein Products (VPP)大豆蛋白制品标准General Standard for Soy Protein Products (SPP)粗粒硬质小麦和硬质小麦粉标准Standard for Durum Wheat Semolina and Durum Wheat Flour大米标准Standard for Rice小麦和硬质小麦标准Standard for Wheat and Durum Wheat花生标准Standard for Peanuts燕麦标准Standard for Oats古斯（蒸熟的硬质小麦餐）标准Standard for Couscous果汁及相关产品标准名称杏蜜、桃蜜和梨蜜标准(采用物理方法保藏) Standard for Apricot, Peach and Pear Nectars Preserved Exclusively by Physical Means桔子汁标准（仅用物理方法保藏）Standard for Orange Juice Preserved Exclusively by Physical Means葡萄柚汁标准（仅用物理方法保藏）Standard for Grapefruit Juice Preserved Exclusively by Physical Means柠檬汁标准（仅用物理方法保藏）Standard for Lemon Juice Preserved Exclusively by Physical Means苹果汁标准（仅用物理方法保藏）Standard for Apple Juice Preserved Exclusively by Physical Means蕃茄汁标准（仅用物理方法保藏）Standard for Tomato Juice Preserved Exclusively by Physical Means浓缩苹果汁标准（采用物理方法浓缩）Standard for Concentrated Apple Juice Preserved Exclusively by Physical Means浓缩桔子汁标准（采用物理方法浓缩）Standard for Concentrated Orange Juice Preserved Exclusively by Physical Means葡萄汁标准（仅用物理方法保藏）Standard for Grape Juice Preserved Exclusively by Physical Means浓缩葡萄汁标准（采用物理方法浓缩）Standard for Concentrated Grape Juice Preserved Exclusively by Physical Means浓缩拉布鲁斯卡甜葡萄汁标准（采用物理方法浓缩）Standard for Sweetened Concentrated Labrusca Type Grape Juice Preserved Exclusively by Physical Means菠萝汁标准（仅用物理方法保藏）Standard for Pineapple Juice Preserved Exclusively by Physical Means无果肉的黑加仑果蜜标准(采用物理方法保藏) Standard for Non-pulpy Blackcurrant Nectar Preserved Exclusively by Physical Means黑加仑汁标准（仅用物理方法保藏）Standard for Blackcurrant Juice Preserved Exclusively by Physical Means浓缩黑加仑汁标准（采用物理方法浓缩）Standard for Concentrated Blackcurrant Juice Preserved Exclusively by Physical Means含某种小浆果的果肉蜜标准(采用物理方法保藏) Standard for Pulpy Nectars of Certain Small Fruits Preserved Exclusively by Physical Means含桔的果蜜标准(采用物理方法保藏) Standard for Nectars of Certain Citrus Fruits Preserved Exclusively by Physical Means浓缩菠萝汁标准（采用物理方法浓缩）Standard for Concentrated Pineapple Juice Preserved Exclusively by Physical Means采用防腐剂加工的浓缩菠萝汁标准Standard for Concentrated Pineapple Juice with Preservatives, for Manufacturing番石榴果蜜标准(采用物理方法保藏) Standard for Guava Nectar Preserved Exclusively by Physical Means芒果果肉液标准(采用物理方法保藏) Standard for Liquid Pulpy Mango Products Preserved Exclusively by Physical Means其它未涉及的果蜜通用标准(采用物理方法保藏) General Standard for Fruit Nectars Preserved Exclusively by Physical Means Not Covered by Individual Standards其它未涉及的果汁通用标准（仅用物理方法保藏）General Standard for Fruit Juices Preserved Exclusively by Physical Means Not Covered by Individual Standards蔬菜汁通用标准General Standard for Vegetable Juices食品分类标准名称预包装食品标签通用标准General Standard for the Labelling of Prepackaged Foods辐照食品通用标准General Standard for Irradiated Foods食品添加剂销售时的标签通用标准General Standard for the Labelling of Food Additives when Sold as Such食用盐标准Standard for Food Grade Salt食品添加剂通用法典标准前言Preamble to the General Standard for Food Additives食品中污染物和毒素通用法典标准前言Preamble to the General Standard for Contaminants and Toxins in Foods再加工用花生中黄曲霉毒素最大限量标准Standard for Maximum Level for Aflatoxins in Peanuts intended for Further Processing。
fda三聚氰胺的检测方法
fda三聚氰胺的检测方法GC-MS Screen for the Presence of Melamine(Adapted from FDA/ORA Forensic Chemistry Center SOP T015)Revised April 10, 2007PURPOSE:This procedure provides a general guide for the sample preparation and analysis of wheat gluten and pet food matrices for melamine using gas chromatography/mass spectrometry. This procedure is designed to screen the TMS derivative of a methanol extract of the sample and it incorporates instrumental parameters which permit 10.5 minute run times.SCOPE:This proc edure is applicable to dry wheat gluten, dry pet food, and wet “cuts and gravy” type pet food. This procedure involves extractions in methanol and therefore preselects compounds which are soluble or partially soluble in methanol. Due to solubility limitations of melamine in methanol, this method is intended to be a qualitative screen only.RESPONSIBILITY:It is the responsibility of the analyst to note any modifications to this procedure in the worksheet.DEFINITIONS AND ACRONYMS:TMS – trimethylsilylSAFETY CONSIDERATIONS:Accepted safety measures should be employed when working with chemicals and pressurized gases.EQUIPMENT:Agilent 5975 GC-MS system equipped with a 30m DB-5MS column (or equivalent)Reacti-Vap – Evaporating/Heating ModuleREAGENTS:Methanol: HPLC gradePyridine: Certified A.C.S.BSTFA with 1% TMCS: bis(trimethylsilyl)trifluoroacetamide with 1%Trimethylchlorosilane (e.g. Sylon BFT, Supelco)QC ELEMENTS:A blank should be run at the onset of each analysis and then randomly throughout the analysis if there is suspicion of carryover. A fortified sample (see Part C) should be analyzed with each set of samples to demonstrate effective system performance.PROCEDURES (PROCESS DETAILS):This procedure may be used with the GC operating in either the splitless or split (1:20) mode. Generally, the splitless mode is advisable for samples where more sensitivity is required. The split mode is suitable where sample availability is not limited and the recommended amount can be prepared (~0.5 g sample preparations).A. Methanol Extract (Underivatized Extract):Unknown Wheat Gluten/Pet Food Samples: Transfer approximately 0.500 g of the sample into a 20 ml scintillation vial and add 5 ml methanol. Vortex briefly to mix, then sonicate for 10 minutes. Centrifuge for approximately 6 minutes at 4500 rpm and then filter the liquid extract into a GC vial using a 0.45 µm nylon filter disc. If sample is limited, reduce extraction volumes and sample weights proportionately and analyze in the splitless mode. Duplicate preparations are recommended.B. Trimethylsilyl (TMS) derivatives:Melamine is detected as the 3-TMS derivative with a nominal molecular weight of 342 amu. The retention time of the 3-TMS derivative is approximately 7.1 minutes in the GC-MS chromatogram (see Figures 1-4).Blanks: Transfer 40µL of methanol used to extract the sample to an autosamplervial. Evaporate to dryness under a stream of dry air using a Reacti-Vap module set at approximately 70°C. Add 200 µl pyridine and 200 µl BSTFA, vortex briefly to mix, and incubate at approximately 70°C for 30 minutes.Known Samples: In general, if working with a known concentration of analyte (e.g. standards), appropriate dilutions should be made with pyridine/BSTFA to achieve an on column concentration no greater than 100 µg/mL. After calculating suitable dilutions, transfer an appropriate amount of the standard solution to an autosampler vial. Evaporate to dryness under a stream of dry air using a Reacti-Vap module set at approximately70°C. Add 200 µl pyridine and 200 µl BSTFA, vortex briefly to mix, and incubate at approximately 70°C for 30 minutes.Unknown Samples: Transfer 40 µl of the methanol extract prepared for analysis in section A into an autosampler vial. Evaporate to dryness under a stream of dry air using a Reacti-Vapmodule set at approximately 70°C. Add 200 µl pyridine and 200 µl BSTFA, vortex briefly to mix, and incubate at approximately 70°C for 30 minutes.C. Sample Fortification:This method was successfully applied to detect melamine in wet and dry pet food composites (Figure 2) and dry wheat glutens (Figure 3). Based on HPLC-UV results, this method was able to detect melamine levels down to 0.01% (by weight) in official FDA samples using ~0.500 g samples with TMS derivatization and splitless injection.Uncontaminated wheat gluten and pet food composites were spiked with various levels of melamine and taken through the method using ~0.500 g samples and splitlessinjection. The method successfully detected melamine (as the 3TMS derivative) at 14 micrograms/g in the wheat gluten and at 7 micrograms/g in the pet food composite. At low spike levels, extracted ion chromatograms were used to verify the presence of four major ions of the melamine-TMS mass spectrum (m/z=342, 327, 171, and 99). Sample fortification experiments to demonstrate successful detection of melamine in the specific matrix of interest should be performed by the individual laboratories.D. Standard Preparation:Melamine is sparingly soluble in methanol and slightly more soluble in methanol/water mixtures. Up to ~1.5 mg/mL of melamine standard can be dissolved in a 50/50 mixture of methanol/water with sonication for 30 minutes. If more concentrated solutions of melamine are desired, dimethyl sulfoxide (DMSO) may be used as a primary solvent followed by methanol or acetonitrile for serial dilutions.Note: Due to the presence of water in the standard solution, dry down times forthe melamine standard on the Reacti-Vap will be increased.E. Instrument Parameters:INSTRUMENT: 5975 Agilent GC 6890N Series with 7683B SeriesautosamplerDETECTOR: Agilent Mass Selective Detector (MSD) model 5975iSOFTWARE: Enhanced Chemstation version D.02.00.275; Wiley 7th Editionand NIST 02 MS LibraryCOLUMN: J&W Scientific DB-5MS 5% Phenyl Methyl Siloxane with 10MDuraguardPart #19091S-433, Serial # US4937937HID: 0.25mm Film Thickness: 0.25 microns Length: 30meters (nominal)CARRIER GAS: HeliumFlow Rate: 1.3 ml/minAvg. Linear Velocity: 35 cm/secPressure: 17.5 psi (initial)Mode: constant flowINJECTION: Injection Type: Splitless; or Split (1:20)Injection Volume: 1µlInjector Temperature: 250ºCSplitless Injection Purge Flow: 10.0 ml/min at 2.0 minutesGC PARAMETERS: Start Temperature: 75ºC; Hold: 1.0 minRamp Rate: 30ºC/minFinal Temperature: 300ºC; Hold: 2.0 minTransfer Line Temperature 280ºCRun Time: 10.5 minutesMS PARAMETERS: Mass Range: 40-450 amuScan Mode: Full (Electron Ionization)Filament Delay: 4.2 min (splitless); 3.8 min (split)Threshold: 100MS Quad: 150ºCMS Source: 230ºCF. Peak Identification:The mass spectrum of the 3-TMS derivative of melamine (Figure 1) exhibits the molecular ion at m/z=342, a methyl group loss at m/z=327, and significant ions at m/z=171, 99, and 73. The standard of melamine should be prepared (and TMS-derivatized) and analyzed along with the sample preps on the same day to confirm the identification. Figures 2a and 2b are examples of a GC-MS chromatogram of melamine contaminated pet food. Additional peaks present in the TIC are consistent with TMS derivatives of phosphate and various sugars. Figure 3 is an example of a GC-MS chromatogram of melamine contaminated wheat gluten.Figure 1Figure 2aFigure 2bFigure 3Web page updated by mdt - April 11, 2007, 10:26 AM ETUpdated FCC Developmental Melamine Quantitation (HPLC-UV)April 2, 2007Sample Preparation/Extraction:Wheat gluten: Ground in a Retsch ZM 100 centrifugal rotor mill (ring sieve 0.5 mm).Moist pet food: Moist chunks and gravy were blended to the consistency of a gritty pudding prior to sampling.Samples weighed into glass scintillation vials. Extract using 50:50 acetonitrile:water.Procedure: Add indicated volume of extraction solvent (see note below) 1. Cap and vortex thoroughly, get aggressive with this step (critical due to slow dissolution rate of melamine). Sonicate 30 minutes. Filter portion of extract through 2-stage GMF-nylon (0.45 m m) filters. Dilute filtered extract 250 μl extract + 750 μl solvent 2 to maintain solubility of matrix components.1 Wheat gluten: Extract in proportion 0.1 g to 10 ml. For melamine contents above 2% w/w, extract in proportion 0.05 g to 15 ml.1 Moist pet food: Extract in proportion 2.0 – 2.5 g to 10 ml.2 Solvent for final dilution may be water or 0.1 N HCl. Final dilution is necessary for compatibility with ion-pairing chromatography. We have observed some differences in behavior between the wheat gluten and pet food samples with respect to maintaining solubility during final dilution (these are most likely matrix components which fall out). 0.1 N HCl seems to help maintain solubility for final dilution of the wheat glutens.HPLC-UV Operating Parameters:Column: Zorbax Rx C8 (retention is too high on C18 column)Buffer: 10 mM citric acid, 10 mM sodium octane sulfonate, adjusted to pH 3.0Mobile phase: 85:15 buffer:acetonitrileFlow rate: 1.0 ml/min.Injection volume: 10 μlColumn thermostat: 40 o C (column thermostatting is necessary for ion-pair separations) Detection wavelength: 240 nmSpectral collection: 200 – 400 nm (look for λmax near 236 nm)Retention time: 4.2 - 4.3 min.Run time: 10 min.Standard Preparation:Stock standard was prepared in 76:24 acetonitrile: water. A check stock standard was prepared in 60:40 acetonitrile: water. Dilutions were made in either water or 0.1N HCl giving equivalent calibration curves.Figures of Merit:Linear range: established from 1.0 – 400 μg/ml; calibration range 1.0 – 200 μg/ml used formost of workReproducibility: duplicate preparations agree within 0.1 - 5% relative basisSpike/recovery (based on spiking solid melamine powder into test matrix prior to extraction): 90 -110%.Web page updated by mdt - April 3, 2007, 9:08 AM ET。
美国FDA原料药生产质量管理规范标准
DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAWMATERIALS BY FDA美国FDA原料药生产质量管理规（中英文）Table of Contents 目录1. INTRODUCTION 简介1.1 Objective 目的1.2 Regulatory Applicability法规的适用性1.3 Scope 围2. QUALITY MANAGEMENT .质量管理2.1 Principles 总则2.2 Responsibilities of the Quality Unit(s) 质量部门的责任2.3 Responsibility for Production Activities 生产作业的职责2.4 Internal Audits (Self Inspection) 部审计（自检）2.5 Product Quality Review 产品质量审核3. PERSONNEL 人员3.1 Personnel Qualifications 人员的资质3.2 Personnel Hygiene 人员卫生3.3 Consultants 顾问4. BUILDINGS AND FACILITIES 建筑和设施4.1 Design and Construction 设计和结构4.2 Utilities 公用设施4.3 Water 水4.4 Containment 限制4.5 Lighting 照明4.6 Sewage and Refuse 排污和垃圾4.7 Sanitation and Maintenance 卫生和保养5. PROCESS EQUIPMENT 工艺设备5.1 Design and Construction 设计和结构5.2 Equipment Maintenance and Cleaning 设备保养和清洁5.3 Calibration. 校验5.4 Computerized Systems 计算机控制系统6. DOCUMENTATION AND RECORDS 文件和记录6.1 Documentation System and Specifications 文件系统和质量标准6.2 Equipment cleaning and Use Record 设备的清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials 原料、中间体、原料药的标签和包装材料的记录6.4 Master Production Instructions (Master Production and Control Records)生产工艺规程（主生产和控制记录）6.5 Batch Production Records (Batch Production and Control Records)批生产记录（批生产和控制记录）6.6 Laboratory Control Records 实验室控制记录6.7 Batch Production Record Review 批生产记录审核7. MATERIALS MANAGEMENT 物料管理7.1 General Controls 控制通则7.2 Receipt and Quarantine 接收和待验7.3 Sampling and Testing of Incoming Production Materials 进厂物料的取样与测试7.4 Storage 储存7.5 Re-evaluation 复验8. PRODUCTION AND IN-PROCESS CONTROLS 生产和过程控制8.1 Production Operations 生产操作8.2 Time Limits 时限8.3 In-process Sampling and Controls 工序取样和控制8.4 Blending Batches of Intermediates or APIs 中间体或原料药的混批8.5 Contamination Control 污染控制9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES原料药和中间体的包装和贴签9.1 General 总则9.2 Packaging Materials 包装材料9.3 Label Issuance and Control 标签发放与控制9.4 Packaging and Labeling Operations 包装和贴签操作10. STORAGE AND DISTRIBUTION.储存和分发10.1 Warehousing Procedures 入库程序10.2 Distribution Procedures 分发程序11. LABORATORY CONTROLS 实验室控制11.1 General Controls 控制通则11.2 Testing of Intermediates and APIs 中间体和原料药的测试11.3 Validation of Analytical Procedures 分析方法的验证11.4 Certificates of Analysis分析报告单11.5 Stability Monitoring of APIs 原料药的稳定性监测11.6 Expiry and Retest Dating 有效期和复验期11.7 Reserve/Retention Samples 留样12. VALIDATION .验证12.1 Validation Policy 验证方针12.2 Validation Documentation 验证文件12.3 Qualification 确认12.4 Approaches to Process Validation 工艺验证的方法12.5 Process Validation Program 工艺验证的程序12.6 Periodic Review of Validated Systems 验证系统的定期审核12.7 Cleaning Validation 清洗验证12.8 Validation of Analytical Methods 分析方法的验证13. CHANGE CONTROL 变更的控制14. REJECTION AND RE-USE OF MATERIALS.拒收和物料的再利用14.1 Rejection 拒收14.2 Reprocessing 返工14.3 Reworking 重新加工14.4 Recovery of Materials and Solvents 物料与溶剂的回收14.5 Returns 退货15. COMPLAINTS AND RECALLS 投诉与召回16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者17.1 Applicability 适用性17.2 Traceability of Distributed APIs and Intermediates已分发的原料药和中间体的可追溯性17.3 Quality Management 质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates原料药和中间体的重新包装、重新贴签和待检17.5 Stability 稳定性17.6 Transfer of Information 信息的传达17.7 Handling of Complaints and Recalls 投诉和召回的处理17.8 Handling of Returns 退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation用细胞繁殖/发酵生产的原料药的特殊指南18.1 General 总则18.2 Cell Bank Maintenance and Record Keeping 细胞库的维护和记录的保存18.3 Cell Culture/Fermentation 细胞繁殖/发酵18.4 Harvesting, Isolation and Purification 收取、分离和精制18.5 Viral Removal/Inactivation steps 病毒的去除/灭活步骤19. APIs for Use in Clinical Trials 用于临床研究的原料药19.1 General 总则19.2 Quality 质量19.3 Equipment and Facilities设备和设施19.4 Control of Raw Materials 原料的控制19.5 Production 生产19.6 Validation 验证19.7 Changes 变更19.8 Laboratory Controls 实验室控制19.9 Documentation 文件20. Glossary 术语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（GMP）提供指南。
国际食品法典委员会“液态婴儿配方奶”三聚氰胺限量要求
国际食品法典委员会关于“液态婴儿配方奶”中三聚氰胺的限量要求（英文原文）UN strengthens regulations on melamine, seafood, mel ons, dried figs and labellingConsumers to benefit from new food safety standardsNews release4 July 2012 | Rome - The UN food standards body has agreed on new regulations – including the maximum level of melamine in liquid milk formula for babies – to protect the health of consumers across the world. Other measures adopted include new food safety standards on seafood, melons, dried figs and food labelling.The Codex Alimentarius Commission, jointly run by the UN Food and Agriculture Organization (FAO) and WHO, sets international food safety and quality standards to promote safer and more nutritious food for consumers worldwide. Codex standards serve in many cases as a basis for national legislation, and provide the food safety benchmarks for international food trade.MelamineMelamine can be lethal at high concentrations and has been used illegally to increase apparent protein content in food products including infant formula and milk powder. Milk tainted with melamine has caused death and illness in infants. Two years ago, the Codex Commission adopted a maximum melamine level of 1 mg/kg for powdered infant formula and of 2.5 mg/kg for other foods and animal feed. The Commission has now set a maximum limit of 0.15 mg/kg for melamine in liquid infant milk.Melamine is used to make dishware and kitchenware, among other industrial applications. The new limit will help governments protect consumers by determining if detected levels of melamine result from unavoidable melamine contamination that does not cause health problems or from deliberate adulteration.Dried figs and aflatoxinsAflatoxins, a group of mycotoxins produced by molds, are toxic and are known to be carcinogenic. They can be found in a variety of products such as dried fruits, nuts, spices and cereals at high levels if the produce is not stored properly. The Commission now agreed a safe maximum limit of 10 mg/kg for dried figs, together with details on how test sampling should be conducted.MelonsAn emerging public health issue relates to the increased popularity of pre-cut melon slices. Exposed pulp of the fruit can become a breeding ground for bacteria. This has been linked to life-threatening salmonella and listeria outbreaks.The Commission recommended that pre-cut melons should be wrapped or packaged and refrigerated as soon as possible and distributed at temperatures of 4⁰ C or less. Cooling and cold-storing was recommended as soon as possible after harvest, while knife blades used for cutting or peeling should be disinfected on a regular basis.Seafood and virusesFood hygiene in seafood, particularly for molluscs, such as mussels and oysters, have become a major food safety concern. The Commission adopted a set of preventive hygiene measures aimed to control food-borne viruses. Viruses are generally more resistant than bacteria and those transmitted by the faecal-oral route can persist for months in bivalve molluscs, soil, water and sediments. They can survive freezing, refrigeration, UV radiation and disinfection but are sensitive to heat.Common food-borne viral diseases are caused by hepatitis A virus and norovirus. The Commission noted that the main hazard for the production of molluscs, such as oysters and mussels, was the biological contamination of the waters in which they grow.It is therefore important to ensure the seawater quality of growing areas, the Commission noted. When there is a likelihood or evidence of viral contamination, closure of the area, destruction of contaminated molluscs and/or heat treatment before consumption of already harvested molluscs is recommended.Mandatory nutrition labelingCodex recommended that food manufacturers across the world label nutritional content on their products to ensure that consumers are better informed; the recommendation is in line with WHO’s Strategy on Diet, Physical Activity and Health and is a major step forward in promoting healthy eating worldwide.The 49-year-old Codex Alimentarius Commission, meeting from 2–7 July, is attended by 600 delegates representing 184 countries plus the European Union. For more information please contactGlenn ThomasWHO, GenevaMobile: +41 79 509 0677E-mail: thomasg@who.int。
美装备质量管理标准
美装备质量管理标准Quality management standards are essential in any industry to ensure that products or services meet certain criteria. In the beauty equipment industry, adhering to strict quality management standards is crucial to provide customers with safe and effective products. Beauty equipment, such as skin care devices, hair styling tools, and spa equipment, directly impact a person's well-being and appearance, so it is important to maintain high quality throughoutthe manufacturing process. From the selection of raw materials tothe final product testing, every step must be carefully monitored to meet quality control standards.美容设备行业中的质量管理标准是至关重要的，以确保产品符合一定的标准。
美容设备，如护肤设备、造型工具和spa设备，直接影响一个人的幸福和外表，因此在整个制造过程中保持高质量非常重要。
从原材料的选择到最终产品测试，每一步都必须经过仔细监控以满足质量控制标准。
Firstly, quality management standards help manufacturers establish consistent processes and procedures to ensure that every product manufactured meets specific requirements. By implementing thesestandards, companies can identify potential issues early in the production cycle and take corrective actions to prevent defects. This proactive approach not only improves product quality but also reduces the likelihood of costly recalls or customer complaints. In the competitive beauty equipment market, maintaining a positive reputation for quality is essential for attracting and retaining customers.首先，质量管理标准帮助制造商建立一致的流程和程序，确保每个制造的产品都符合特定要求。
氟尼新葡甲胺质量标准英文
氟尼新葡甲胺质量标准英文Title: Fluorfenicol Meglumine Quality Standards.The fluorfenicol meglumine, also known as Flunixin Meglumine, is a widely used veterinary drug that fallsunder the category of non-steroidal anti-inflammatory drugs (NSAIDs). It is primarily utilized as an analgesic andanti-inflammatory agent in animals, effectively relieving pain and reducing inflammation. Given its widespread application, it is crucial to ensure that the quality standards of fluorfenicol meglumine are strictly adhered to.The quality standards for fluorfenicol meglumine primarily revolve around its purity, potency, and stability. These standards are typically outlined in pharmacopeiassuch as the United States Pharmacopeia (USP) and theBritish Pharmacopeia (BP).Purity is a key aspect of fluorfenicol meglumine quality. The drug should be free from impurities andcontaminants that could potentially harm the animal. Manufacturers are required to use high-quality raw materials and employ purification techniques to ensure the purity of the final product. This is typically achieved through various purification processes, including crystallization, filtration, and chromatography.Potency refers to the biological activity of the drug, which is measured through bioassays or chemical assays. Fluorfenicol meglumine should meet specific potency requirements to ensure its effectiveness. Manufacturers are required to conduct rigorous quality control tests to assess the potency of each batch of fluorfenicol meglumine. These tests help ensure that the drug meets the potency specifications outlined in the pharmacopeias.Stability is another crucial aspect of fluorfenicol meglumine quality. The drug should remain stable under various storage conditions, maintaining its potency and purity over time. Manufacturers are required to conduct stability studies to assess the shelf-life of the drug. These studies involve storing fluorfenicol meglumine underdifferent temperature and humidity conditions and monitoring its potency and purity over time.In addition to purity, potency, and stability, fluorfenicol meglumine should also meet specific packaging requirements. The drug should be packaged in tamper-proof containers that protect it from moisture, light, and other environmental factors that could affect its quality. Additionally, the packaging should include clear labeling, indicating the name of the drug, its potency, expiration date, and other relevant information.Overall, ensuring the quality of fluorfenicol meglumine is crucial for its effective use as a veterinary drug. Manufacturers, distributors, and veterinarians alike should adhere to strict quality standards to ensure the safety and efficacy of this important drug. By doing so, they can help promote the health and welfare of animals and contribute to the overall health of the veterinary industry.。
Qualicoat-质量标准
Qualicoat质量标准《建筑用铝型材表面喷漆、粉末涂装的质量控制规范》第11 版QUALICOAT 执行委员会在2005年11月17日通过有效期从2006年4月1日起这一个版本代替早先的版本，而且包括第 10 版的 1 — 24 项的更新，可能有新项目的补充。
所有的更新资料将在英特网上出版 : 声明：本翻译稿为初稿，请在中文网站上下载最新版。
与 2003 年4月发行第 10 版比较的主要变化第 10 版第 1 项：批量含铬钝化处理(附录一8)第 10 版第 2 项：冲击试验第 10 版第 3 项：前处理后的干燥第 10 版第 4 项：前处理系统的备选方案（新附件 A6 ）第 10 版第 5 项：在铸件上的喷涂（新附件 A5 ）第 10 版第 6 项： 2 级粉末喷涂的评估第 10 版第 7 项：起泡度第 10 版第 8 项：标准的实用性或操作指导第 10 版第 9 项：注册投诉的有效性第 10 版第 10 项：正表面第 10 版第 11 项：粉末供应商的最少仪器要求第 10 版第 12 项：实验室仪器第 10 版第 13 项：灰浆测试后的颜色评估第 10 版第 14 项：在喷涂及涂饰之间的最大时间第 10 版第 15 项：自然气候测试时颜色变化的测量第 10 版第 16 项： 2 级液体涂饰的要求第 10 版第 17 项：金属颜色的评估规则第 10 版第 18 项：证书授予第三方的规则第 10 版第 19 项：铬酸盐处理前的最后一道水洗的导电率第 10 版第 20 项：均一的前处理第 10 版第 21 项：有关标准的目录 (附录一9)第 10 版第 22 项：在包装，标志上标明 " QUALICOAT" 和批准号第 10 版第 23 项：受予执照的检验第 10 版第 24 项：关于禁止的颜色规则更新的DeltaE(附录A7)目录1．概论2.测试方法及要求2.1. 外观2.2.光泽度2.3. 涂层厚度2.4. 附着力2.5. 压痕试验2.6. 杯突试验.2.7. 抗弯曲性试验2.8. 耐冲击性试验2.9. 耐含二氧化硫潮湿空气的试验2.10. 耐醋酸盐雾试验2.11. 马丘 Machu 试验2.12. 加速风化试验2.13. 自然气候试验2.14. 耐聚合试验2.15. 耐灰浆试验2.16. 耐沸水试验2.17. 耐冷凝水试验2.18. 抗锯，铣，钻3. 操作规范3.1. 待处理部件的储藏及设备的区划3.2. 粉末和液体涂饰的前处理3.2.1 蚀刻3.2.2 铬酸盐前处理3.2.3 阳极氧化前处理3.2.4 其他前处理3.3. 电泳的前处理3.4. 干燥3.5. 干燥炉3.6. 实验室3.7. 内部控制3.8. 操作指导3.9. 登记册4. 涂装材料的核准4.1. 授予许可4.1.1 最少的实验室仪器4.1.2 测验4.2. 批准的复审系统5. 喷涂工厂的批准证书5.1. 批准证书的授予（质量标志）5.1.1实验室仪器的检验5.1.2工厂和设备的检验5.1.3 前处理的检验5.1.4 成品的检验5.1.5 试验样片的检验5.1.6 对注册工厂的考核5.1.7 授予证书的最后评估5.2. 证书获许人的常规考核5.3. 喷涂工厂的标志使用6. 内部的控制规范6.1. 试验参数6.1.1 前处理槽6.1.2 水质6.1.3 前处理及水洗槽的温度测量6.1.4干燥温度测量6.2. 生产过程的质量控制6.2.1蚀刻度试验6.2.2涂层转化重量验测(DIN 50939)6.2.3 炉况测试6.3. 成品的质量控制6.3.1 光泽度试验 (ISO 2813)6.3.2 涂层厚度试验 (EN ISO 2360)6.3.3 外观试验6.3.4 附着力试验(EN ISO 2409) .6.3.5 压痕试验(EN ISO 2815)6.3.6 聚合试验6.3.7 杯突试验(EN ISO 1520).6.3.8 抗弯曲性(EN ISO 1519).6.3.9 耐冲击性(ENISO 6272/ASTM D 2794)6.3.10马丘 Machu 试验.6.4. 注册工厂的质量控制6.4.1 生产工艺的控制6.4.2 样片的控制6.4.3 成品的控制6.5. 内部控制规范汇总表附件A1 在建筑用铝型材表面喷漆，粉末涂装产品上使用： " QUALICOAT" 标志的规则A2 装饰性表面的规范A3 关于" QUALICOAT"认证过的粉末配方变更的强制申告A4 金属喷涂层A5 " QUALICOAT" 质量标志对建筑用铝铸件喷涂的专用规范A6 其他前处理系统评估程序A7 RAL/ DELAT E 表A8 批处理规范A9 相关标准目录概论1.概论本规范适用于 " QUALICOAT" 质量标志, 这是一个已注册商标。
美国原料药生产质量管理规范
DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OFRAW MATERIALS BY FDA美国FDA原料药生产质量管理规范（中英文）Table of Contents 目录1. INTRODUCTION 简介Objective 目的Regulatory Applicability法规的适用性Scope 范围2. QUALITY MANAGEMENT .质量管理Principles 总则Responsibilities of the Quality Unit(s) 质量部门的责任Responsibility for Production Activities 生产作业的职责Internal Audits (Self Inspection) 内部审计（自检）Product Quality Review 产品质量审核3. PERSONNEL 人员Personnel Qualifications 人员的资质Personnel Hygiene 人员卫生Consultants 顾问4. BUILDINGS AND FACILITIES 建筑和设施Design and Construction 设计和结构Utilities 公用设施Water 水Containment 限制Lighting 照明Sewage and Refuse 排污和垃圾Sanitation and Maintenance 卫生和保养5. PROCESS EQUIPMENT 工艺设备Design and Construction 设计和结构Equipment Maintenance and Cleaning 设备保养和清洁Calibration. 校验Computerized Systems 计算机控制系统6. DOCUMENTATION AND RECORDS 文件和记录Documentation System and Specifications 文件系统和质量标准Equipment cleaning and Use Record 设备的清洁和使用记录Records of Raw Materials, Intermediates, API Labeling and Packaging Materials 原料、中间体、原料药的标签和包装材料的记录Master Production Instructions (Master Production and Control Records)生产工艺规程（主生产和控制记录）Batch Production Records (Batch Production and Control Records)批生产记录（批生产和控制记录）Laboratory Control Records 实验室控制记录Batch Production Record Review 批生产记录审核7. MATERIALS MANAGEMENT 物料管理General Controls 控制通则Receipt and Quarantine 接收和待验Sampling and Testing of Incoming Production Materials 进厂物料的取样与测试 Storage 储存Re-evaluation 复验8. PRODUCTION AND IN-PROCESS CONTROLS 生产和过程控制Production Operations 生产操作Time Limits 时限In-process Sampling and Controls 工序取样和控制Blending Batches of Intermediates or APIs 中间体或原料药的混批Contamination Control 污染控制9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES原料药和中间体的包装和贴签General 总则Packaging Materials 包装材料Label Issuance and Control 标签发放与控制Packaging and Labeling Operations 包装和贴签操作10. STORAGE AND DISTRIBUTION.储存和分发Warehousing Procedures 入库程序Distribution Procedures 分发程序11. LABORATORY CONTROLS 实验室控制General Controls 控制通则Testing of Intermediates and APIs 中间体和原料药的测试Validation of Analytical Procedures 分析方法的验证Certificates of Analysis分析报告单Stability Monitoring of APIs 原料药的稳定性监测Expiry and Retest Dating 有效期和复验期Reserve/Retention Samples 留样12. VALIDATION .验证Validation Policy 验证方针Validation Documentation 验证文件Qualification 确认Approaches to Process Validation 工艺验证的方法Process Validation Program 工艺验证的程序Periodic Review of Validated Systems 验证系统的定期审核Cleaning Validation 清洗验证Validation of Analytical Methods 分析方法的验证13. CHANGE CONTROL 变更的控制14. REJECTION AND RE-USE OF MATERIALS.拒收和物料的再利用Rejection 拒收Reprocessing 返工Reworking 重新加工Recovery of Materials and Solvents 物料与溶剂的回收Returns 退货15. COMPLAINTS AND RECALLS 投诉与召回16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者Applicability 适用性Traceability of Distributed APIs and Intermediates已分发的原料药和中间体的可追溯性Quality Management 质量管理Repackaging, Relabeling, and Holding of APIs and Intermediates原料药和中间体的重新包装、重新贴签和待检Stability 稳定性Transfer of Information 信息的传达Handling of Complaints and Recalls 投诉和召回的处理Handling of Returns 退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation用细胞繁殖/发酵生产的原料药的特殊指南General 总则Cell Bank Maintenance and Record Keeping 细胞库的维护和记录的保存Cell Culture/Fermentation 细胞繁殖/发酵Harvesting, Isolation and Purification 收取、分离和精制Viral Removal/Inactivation steps 病毒的去除/灭活步骤19. APIs for Use in Clinical Trials 用于临床研究的原料药General 总则Quality 质量Equipment and Facilities设备和设施Control of Raw Materials 原料的控制Production 生产Validation 验证Changes 变更Laboratory Controls 实验室控制 Documentation 文件20. Glossary 术语1. INTRODUCTION 1. 简介Objective 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。
USP的计量学观点 Roger Williams, M.D. 美国药典委员会首席执行官兼执行副总裁.
ISO Guide 34 Accreditation
USP首个有证标准物质
国家可溯源性链
SI NIST USP
Calibration Labs (校准实验室)
Routine Measurement Labs (常规检验实验室)
Mass fraction (mg/g)
结果 - CCQM-P20.e.2
Theophylline content of CCQM-P20.e.2
计量学条款
物质
程序
USP标准物质
应用于USP–NF检测的标准物质超过2,200个。
高度标化的样品:
药物原料 赋形剂 杂质
通过USP，企业以及政府的科学家 的严格测试
USP标准物质（接上）
• USP 也 提 供 在 «食 品 化 学 法 典 » （ Food Chemicals Codex）中指定的标准物质以及对照物质（高质量化学 品），以服务于分析，临床，药品和研究实验室。
方法和步骤
常规测量方法和步骤 生产厂家工作测量方法和步骤 生产厂家参考测量方法和步骤
可溯源性
USP标准物质
USP法定方法
有证参考物质
基本参考测量方法和步骤
定义的测量单位
USP的计量学纲要
USP为药品和食物成分制定了相应的程序文件和参考标准。 这些标准可以为法定机构和生产厂家所使用（包括药品， 非处方药，食品补充剂以及食品成分的生产厂家）以确保 这些产品具有确切的鉴别，规格，质量和纯度。
《完整的一套产品检测标准(英文)》(doc28)-质量检验【管理资料】
MTL/ SGS TEST LIST (1)(Seating)(Combines Adult and Children’s sizes,:Chairs, Barstools, Ottomans,)MTL/ SGS TEST LIST (2) (CD Storage/Rack/Cabinet/ chest/ chest)MTL/ SGS TEST LIST (3)thSupporting surface loading parametersable Simulated Television Load ParametersTThe fixture shall be stable in the forward direction at the angle specified and become unstable (tip over) when the angle is increased b degree.Includes weight of text fixture.MTL/ SGS TEST LIST (4)Bed (For Trundle and Regular Beds, Adult use)MTL/ SGS TEST LIST (5)（Bunk Bed）MTL/ SGS TEST LIST (6)（Tables (Combines Adult and Children’s sizes, Indoor/Outdoor, for the following styles: Dining, camping, occasional and coffee tables, desks, nightstands, work bench, potting bench, storageMTL/ SGS TEST LIST (7)(Seating)(Combines Adult and Children’s sizes,:Chairs, Barstools, Ottomans,)MTL/ SGS TEST LIST (8)(Seating)(Combines Adult and Children’s sizes,:Chairs, Barstools, Ottomans,)包装测试1．For all carton dimensions as usual:Dimensions refer to the exterior of a carton, measured in inches of Length x Width x Height. in inches (mm or m)Length (L) is the longer side of the opening,Width (W) is the shorter.Height (H) is the length between the openings on either end.1．。
ISO质量认证体系介绍Introduction to the ISO 9000 Quality Standard
4-07-20 Introduction to the ISO 9000 Quality Standard PreviousWilliam E. PerryPayoffOrganizations developing software or contracting for its development may need to complywith ISO 9000, a quality standard published by the International Standards Organization inGeneva. This article is intended to familiarize the IS manager with the ISO 9000 standard,how it compares with the Malcolm Baldrige National Quality Award, and how anorganization and its auditors prepare for certification. An overview of the softwaredevelopment standard is included.IntroductionThe International Standards Organization (ISO) is a worldwide federation of nationalstandards bodies. The work of preparing international standards is carried out through ISOtechnical committees. Each member body interested in a subject for which a technicalcommittee has been established has the right to be represented on that committee. In liaisonwith International Standards Organization, international organizations (governmental andnongovernmental) also take part in the work.The emphasis for international standards originated in the European Community's plan to become a single market with international standards becoming effective at the end of1992. At that time, organizations wishing to do business in the common market wererequired to meet those standards, which are now accepted worldwide. There are five relatedquality management standards in what is referred to as the ISO 9000 series. Each of thefive standards(numbered 9000 to 9004) addresses a different topical area.For example, ISO 9000 affects the development and maintenance of software. In addition, the International Standards Organization 9000 standard provides some basicdefinitions and concepts. It summarizes the other standards in the series and explains howto select and use them. The International Standards Organization 9001, 9002, and 9003standards ensure external quality in contractual situations. ISO 9004 contains guidance onthe technical, administrative, and human factors affecting the quality of products andservices.External and Internal QualityThe International Standards Organization 9001 standard is directed at the development of aquality product or service. It is written to ensure conformance to specified requirementsduring design and development, production, installation, and servicing. Because softwaredevelopment is focused on the creation of a product, it is a part of ISO 9001. (See theAppendix for specific guidelines on the 9001 to software development and maintenance.) ISO 9002 is used for production and installation. It is the standard that governs the manufacture of a product. It is designed to ensure conformance to production andinstallation methods.ISO 9003 is the standard directed at the final test and inspection of products. The standard preassumes an extensive quality control function and specifies what is needed forconformance to requirements.ISO 9004 is for internal use only and lists the components that compose quality systems. In the US, the Malcolm Baldrige National Quality Award defines the model of aquality system. International Standards Organization 9004 describes a slightly different Previousquality system, but it, too, provides the detail of the quality system and the responsibilitiesof management. International Standards Organization 9004 as well as the Baldrige Awardstandard could be used to evaluate a company's quality management system to determinethe degree of maturity of that system.ISO 9000 CertificationThe worldwide emphasis on quality has resulted in many organizations evaluating theirsuppliers' processes. These audits of supplier capabilities are sometimes a prerequisite topurchasing. Companies have learned that good processes product good products.One of W. Edwards Deming's 14 quality principles is to limit suppliers to those that demonstrate they can continually produce quality products. Organizations, such as FordMotor Co., that have followed Deming's principles have reduced the number of suppliersdramatically. However, it takes a lot of time and effort for one company to certify theadequacy of the processes of another company.The objective of the International Standards Organization 9000 series of standards is to certify that an organization has quality manufacturing processes. Thus, if a supplier wantedto demonstrate competence of products, it would make application to demonstrate that itmeets the ISO 9000 standards.Countries establish, or accredit, organizations to audit companies to determine whether they are in compliance with the ISO 9000 standards. This is an audit of the organization'sprocesses. If the ISO 9000 auditors determine that the company's processes are incompliance with the standards, they issue a certificate good for three years, subject toannual validation that nothing has changed. Companies receiving the certificate can thenadvertise themselves as being in compliance with the ISO 9000 standards.Documentation RequirementsThe ISO 9000 audit is heavily focused on evaluation of documentation. Four tiers of quality system documentation are required:·First tier—the quality manual.·Second tier—quality management procedures (i.e., core procedures).·Third tier—area work instructions (i.e., standard operating procedures, test methods, calibration methods).·Fourth tier—forms, records, books, and files.The Malcolm Baldrige National Quality Award assessment is focused primarily on results. The ISO 9000 assessment is based solely on documentation. Organizations can becertified under the ISO 9000 standards without demonstrating continuous improvement ofquality products or demonstrating continuous improvement processes. Organizations mayneed several certifications, depending on the diversity of their products.One organization that has obtained certification and has written about it is E. I. du Pont de Nemours & Co. (Quality Progress, November 1991). Du Pont had been subjected tocustomer audits for some time, in which the customers evaluated the organization'sprocesses. However, in preparing for the International Standards Organization 9000 audit,du Pont quickly realized that although it had extensive quality manuals (two at 500 pages Previouseach), most of these quality systems were not adequately defined, documented, orrigorously followed. Du Pont also realized that none of the customer audits had beenconducted with the degree of competence and thoroughness that the ISO 9000 assessmentrequires.The ISO 9000 AuditThe International Standards Organization 9000 audit is the basis for becoming certified. Itis performed by auditors trained in conducting those audits and thoroughly knowledgeableabout the standards. The audits are extensive and can last several days or weeks, dependingon the size of the organization.The audit follows the general pattern of an operational audit. It is much more typical of the audit performed by an internal audit group than that performed by an external auditor.Step 1: Preliminary Walkthrough.The auditor must gain an understanding of the area or department under review. Thisincludes determining what the organization does, getting copies of and understanding theorganizational chart, understanding the products produced, and arriving at an overview ofthe processes that produce those products or services. At the end of this step, the auditorshould have a general understanding of the business of the organization under review.Step 2: Process Control Review.During this step, the auditor attempts to understand the process and whether that process isin place and working. During this review, the auditor asks questions and reviewsdocumentation and other evidential matter. The step involves extensive questioning of thepeople doing the work. For example, if the auditor saw instructions next to a piece of dataentry equipment, the auditor might ask: If the procedure is changed, who changes the sheetof paper next to the data entry equipment? The auditor might also ask such questions asHow do employees determine which tasks they should work on first thing in the morning?How do employees determine the priority for changes made to the software?Step 3: Testing.The auditor must validate that the quality process is in place and working. These tests areusually selected at random. Some auditors use judgment sampling, whereas others usestatistical sampling. What is important is that the auditor is convinced that the qualityprocess as it exists in the manuals is operational within the organization.Step 4: Making a Certification Decision.At the end of step 3, the auditor must make a decision about whether the organizationwarrants ISO 9000 certification. There are general guidelines for this, although thoseguidelines are not well publicized. However, assuming that the ISO 9000 audit is similar inscope to that performed by the Software Engineering Institute, if an organization meets80% of the standards of ISO 9000, it would be certified. In other words, if 80% of theitems within the standard are in place and working, the organization would warrantcertification. This is not a hard-and-fast rule, but it is a guideline for estimating whether anorganization would meet the ISO 9000 certification standard.Preaudit ActivitiesPreviousMany organizations take one to two years to prepare for the International StandardsOrganization 9000 audit. During that time, their processes are defined in greater detail,documented, and placed into practice.Usually, an organization will undertake a concentrated effort to reach a status of quality that warrants ISO 9000 certification before requesting the certification audit. Thesepreassessment and preaudit activities involve four basic steps.Step 1: Understanding the Applicable ISO 9000 Standard.The organization must know precisely which standard it must meet. This can involvetaking an ISO 9000 course, inviting ISO 9000 experts in-house to explain the standard, orconducting extensive self-study based on available ISO 9000 literature.Step 2: Conducting a Preassessment.The existing quality system should be measured against the standard. This would besimilar to the certification audit but not performed for certification. The purpose of thepreassessment is to identify the gap between the current quality system and that system thatwould be needed to gain accreditation.Step 3: Developing a Plan of Action for Quality Improvement.A plan of action should be developed to move the organization from the current qualitylevel to the ISO 9000 certification level. This plan should indicate what should be done, theamount of resources required, and the sequencing of implementation of the actions.Step 4: Implementing Improvements and Reassessing.Management must approve the action plan, allocate the resources, and oversee theimplementation of the action plan. Once the necessary actions have been implemented, thequality system should be preassessed again. If the preassessment does not show theorganization to have reached the ISO 9000 certification level, steps 3 and 4 are repeated asfrequently as necessary to reach the appropriate level.Guidelines for Reaching ISO 9000 CertificationOrganizations that follow certain practices or guidelines appear to be much more successfulin obtaining certification. The recommended guidelines for moving to InternationalStandards Organization 9000 certification are:·Finding a champion in senior management to drive the process for reachingcertification.·Ensuring that all involved parties to the certification programs are adequately trained in the ISO 9000 standard and the organization's objectives for obtaining certification.·Obtaining expertise from an organization knowledgeable in ISO 9000 to act as a consultant during a process. It is generally helpful to have this consultant perform thepreassessment audits.·Developing the quality manual and all quality procedures using the internal staff that Previouswill be responsible for implementing those procedures. Generally, buy-in to qualityprocedures is achieved only when the workers themselves develop those procedures.·Providing incentives and recognition programs for the staff involved in ISO 9000 to be awarded once certification has been achieved.·Communicating progress toward ISO 9000 certification on a regular basis to all employees affected by the ISO 9000 program.·In preparing for ISO 9000 certification, performing only those activities that are necessary for improving the quality of the organization's products and services.Generally, if high-quality products are the objective, the work procedures and standardsto achieve that high quality will satisfy the certification requirements—in other words,certification is a by-product of the quality management system.·Not expecting ISO 9000 certification to solve all the company's quality problems. It is merely a step on the path to continued high quality.Listing of ISO 9000 StandardsThe American National Standards Institute (ANSI, 11 West 42nd Street, New York NY10036) is the major distributor for International Standards Organization 9000 standards inthe US. In other countries, companies should contact their government's standard-settingorganization.The five standards in the ISO 9000 series are:·ISO 9000-1. Quality management and quality assurance standards—Part 1: guidelines for selection and use.·ISO 9000. Quality systems—model for quality assurance in design, development, production, installation, and servicing.·ISO 9002. Quality systems—model for quality assurance in production, installation, and servicing.·ISO 9003. Quality systems—model for quality assurance in final inspection and test.·ISO 9004-1. Quality management and quality system elements—Part 1: guidelines.The quality management and quality assurance standards are:·ISO 9000-2, Part 2: generic guidelines for application of International Standards Organization standards 9001, 9002, and 9003.·ISO 9000-3, Part 3: guidelines for the application of ISO 9001 to the development, supply, and maintenance of software (see the Appendix at the end of this article).·ISO 9000-4, Part 4: application for dependability management.The quality management and quality system elements are:·ISO 9004-2, Part 2: guidelines for services.Previous·ISO 9004-3, Part 3: guidelines for processed materials.·ISO 9004-4, Part 4: guidelines for quality improvement.The guidelines for auditing quality systems are:·ISO 1011-1, Part 1: auditing.·ISO 1011-2, Part 2: qualification criteria for quality system auditors.·ISO 1011-3, Part 3: management of audit programs.ConclusionISO 9000 is an important international standard that affects the way organizations dobusiness, especially in Europe. Individuals in any profession, including IS, should beknowledgeable about the impact of this standard on business.The standard includes an audit to be performed before certification can be awarded.This article describes how an organization's auditors can assist in performingpreassessment audits and help the organization prepare for International StandardsOrganization 9000 certification. Organizations can take three specific actions to understandand prepare for International Standards Organization certification.Awareness TrainingBoth the internal auditors and organizational management need training in the standard,why it is important, and how organizations prepare and become certified. The company'sauditors can participate in this training, arrange for the training, or recommend tomanagement that the training be obtained.Obtaining Guidance in Writing Control ManualsAuditors are viewed as experts in control and should be able to provide guidance in writingcontrol manuals. The auditors can work as a team developing formats and manuals thatdefine the control procedures for the organization. The ISO 9000 is heavily adocumentation audit, and thus well-prepared documentation is important not only inperforming control procedures but in evaluating the adequacy of control procedures.Performing an ISO 9000 Preassessment.Auditors can obtain training in conducting ISO 9000 audits and use those skills to performthe preassessment audit for their own organizations. In instances in which the auditors maynot feel adequate to perform the audit, they may assist the audit team. In this way, they canboth improve their own skills and potentially reduce the cost of having an outside groupperform the ISO 9000 preassessment.Author BiographiesWilliam E. PerryWilliam E. Perry, CPA, CQA, CQE, CIA, CISA, is executive director of the Quality Assurance Institute in Orlando FL.。
环境标准物质标准英文
环境标准物质标准英文Environmental Standard and Substances Standard。
Environmental standard and substances standard refer to the regulations and criteria set by government or international organizations to control and manage the quality of the environment and the substances that may have an impact on the environment. These standards are crucial for maintaining a healthy and sustainable environment, as well asfor protecting human health and the ecosystem.Environmental standard includes air quality standard, water quality standard, soil quality standard, noise standard, and radiation standard. These standards specify the acceptable levels of pollutants and contaminants in the environment, and provide guidelines for monitoring and managing these levels. For example, air quality standard sets limits for pollutants such as sulfur dioxide, nitrogen dioxide, and particulate matter in the air, while water quality standard defines the maximum allowable concentrations of heavy metals, organic pollutants, and pathogens in water bodies.Substances standard, on the other hand, focuses on regulating the production, use, and disposal of hazardous substances. These standards cover a wide range of substances, including chemicals, pesticides, pharmaceuticals, and industrial waste. They aim to minimize the release of harmful substances into the environment, and to ensure that the handling and disposal of these substances are carried out in a safe and responsible manner. For instance, substances standard may specify the permissible levels of toxic chemicals in consumer products, as well as the requirements for labeling, packaging, and storage of hazardous substances.Compliance with environmental standard and substances standard is essential for businesses, industries, and government agencies. By adhering to these standards, they can minimize their environmental impact, reduce the risk of pollution and contamination, and fulfill their legal and ethical responsibilities. Moreover, meeting these standards can enhance their reputation, build trust with stakeholders, and create a competitive advantage in the market.In addition, environmental standard and substances standard play a key role in international trade and cooperation. They serve as a common framework for countries to harmonize their environmental regulations, facilitate the exchange of goods and services, and address transboundary environmental issues. By aligning their standards with international norms, countries can promote environmental sustainability, protect public health, and promote a level playing field for businesses operating in the global market.In conclusion, environmental standard and substances standard are essential tools for protecting the environment, safeguarding human health, and promoting sustainable development. By establishing clear and enforceable criteria, these standards help to prevent pollution, minimize the release of hazardous substances, and ensure that natural resources are used in a responsible and efficient manner. It is imperative for governments, industries, and individuals to uphold these standards and work together to create a clean, safe, and healthy environment for present and future generations. Only by doing so can we achieve a balance between economic growth and environmental protection, and build a more resilient and prosperous world for all.。
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/aboutnice/qualitystandards/qualitystandardICE guidance
Clinical guidelines
• Guidance on the appropriate treatment and care of people with specific diseases and conditions.
Quality Standards for Melanoma
Purpose of NICE quality standards
• Patients, carers and the public can use NICE quality standards to provide information about the quality of care they should expect
/guidance/qualitystandards/moreinfoaboutnicequalitystandards.jsp
Purpose of NICE quality standards
• Patients, carers and the public can use NICE quality standards to provide information about the quality of care they should expect
• Commissioners may use the quality standards to ensure that high quality care is being commissioned through the contracting process or to incentivise provider performance by using the indicators in association with incentive payments such as Commissioning for Quality Improvement (CQUIN)
• Health and social care professionals and public health practitioners can use the quality standards in clinical audit and governance reports or in professional development and validation
/guidance/qualitystandards/moreinfoaboutnicequalitystandards.jsp
Cancer quality standards
Breast cancer (P) Colorectal cancer (P) Lung cancer (P) Ovarian cancer (P) Prostate cancer Cancer chemotherapy Haematological malignancies Head and neck cancer Sarcoma Skin cancer (including melanoma) Children and young people with cancer Metastatic spinal cord compression Referral for suspected cancer Radiotherapy services Bladder Cancer
• Provider organisations can use the quality standards to provide high quality services for patient care and monitor quality improvements or to show successful performance in a national audit or inspection
• Commissioners may use the quality standards to ensure that high quality care is being commissioned through the contracting process or to incentivise provider performance by using the indicators in association with incentive payments such as Commissioning for Quality Improvement (CQUIN)
• Provider organisations can use the quality standards to provide high quality services for patient care and monitor quality improvements or to show successful performance in a national audit or inspection