Review of Outsourced

IPD-产品开发流程-验证阶段活动说明活动Activity活动描述Description继续对项目进行管理和监控Continue Monitoring and Control of Project Execution LPDT-100 FPDT-58 RDPDT-68 TSPDT-58 MNFPDT-58 PROPDT-58 MKTPDT-69A 对项目的执行进行持续的每周例行监视和控制。

Continue weekly monitoring and control of project execution.继续监控产品质量目标和计Continue to 划Monitor and control product quality plan/PQA-100 在验证阶段，继续监控产品质量目标和计划。

In qualify phase, continue to Monitor and control product quality objective and plan.监控并管理配置及更改Monitor and Manage Configuration Changes and SE-240作为持续进行的活动的一部分，对开发和设计活动进行定期性的检查，确保产品需求、规格、配置和其它的产品技术文档没有被随意更改；使用PDM的EC模块来使产品需求、规格、配置和其它技术文档的更改受控（在PDM实施前，使用CMM和公司其它的相关流程）。

As part of an ongoing activity, perform inspections regularly on design and development activities to make sure that the offering requirements, specifications, configuration(s) and other offering technical documents are not changed in anad-hoc manner; maintain control over changes to offering requirements,specifications, configuration(s) and other offering technical documents using ECmodule of PDM (Prior to the implementation of PDM, use CMM and other relevantprocesses of Huawei)设计检视Perform Design InspectionsSE-250作为持续进行的活动的一部分，通过参加由硬件、软件、结构、测试、工业设计、采购、市场和其他项目组成员召开的技术会议或阅读会议纪要来进行设计检查；特别的，查实产品是否符合特定的需求和规格，并对所有偏差或更改进行标注；这项活动为“监控和管理配置及更改”活动提供输入。

Q10 药物质量体系20080604（中英文）INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FORREGISTRATION OF PHARMACEUTICALS FOR HUMAN USEICH HARMONISED TRIPARTITE GUIDELINEICH三方协调指南PHARMACEUTICAL QUALITY SYSTEM药物质量体系Q10Current Step 4 versiondated 4 June 2008This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.Q10 Document History 文件历史1. PHARMACEUTICAL QUALITY SYSTEM (1)1.1 Introduction (1)1.2 Scope (1)1.3 Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards and ICH Q7 (2)1.4 Relationship of ICH Q10 to Regulatory Approaches (2)1.5 ICH Q10 Objectives (2)1.5.1 Achieve Product Realisation (2)1.5.2 Establish and Maintain a State of Control (3)1.5.3 Facilitate Continual Improvement (3)1.6 Enablers: Knowledge Management and Quality Risk Management (3)1.6.1 Knowledge Management (3)1.6.2 Quality Risk Management (3)1.7 Design and Content Considerations (3)1.8 Quality Manual (4)2. MANAGEMENT RESPONSIBILITY (4)2.1 Management Commitment (4)2.2 Quality Policy (5)2.3 Quality Planning (5)2.4 Resource Management (5)2.5 Internal Communication (6)2.6 Management Review (6)2.7 Management of Outsourced Activities and Purchased Materials (6)2.8 Management of Change in Product Ownership (6)3. CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (7)3.1 Lifecycle Stage Goals (7)3.1.1 Pharmaceutical Development (7)3.1.2 Technology Transfer (7)3.1.3 Commercial Manufacturing (7)3.1.4 Product Discontinuation (7)3.2 Pharmaceutical Quality System Elements (7)3.2.1 Process Performance and Product Quality Monitoring System (8)3.2.2 Corrective Action and Preventive Action (CAPA) System (9)3.2.3 Change Management System (10)3.2.4 Management Review of Process Performance and Product Quality (11)4. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (11)4.1 Management Review of the Pharmaceutical Quality System (11)4.2 Monitoring of Internal and External Factors Impacting the Pharmaceutical Quality System (12)4.3 Outcomes of Management Review and Monitoring (12)5. GLOSSARY (13)Annex 1:Potential Opportunities to Enhance Science and Risk Based Regulatory Approaches (16)Annex 2:Diagram of the ICH Q10 Pharmaceutical Quality System Model (17)1．制药质量体系1．1绪论1．2范围1．3ICHQ10与地方GMP要求，ISO标准与ICHQ7之间的关系1．4ICHQ10与法规方法间的关系1．5ICHQ10目的1．5．1产品实现1．5．2控制状态的建立和实现1．5．3 持续改进1．6支持者：知识管理和质量风险管理1．6．1知识管理1．6．2质量风险管理1．7设计和内容方面的考虑1．8质量手册2．管理职责2．1管理承诺2．2质量方针2．3质量策划2．4资源管理2．5内部沟通2．6管理评审2．7外包活动和物料采购的管理2．8产品所有权变更管理3．工艺性能和产品质量的持续改进3．1生命周期阶段目标3．1．1物料研发3．1．2技术转移3．1．3商业化生产3．1．4产品终止3．2制药质量体系原理3．2．1工艺性能和产品质量监控体系3．2．2纠正预防体系3．2．3变更管理体系3．2．4工艺性能和产品质量的管理评审4．制药质量体系的持续改进4．1制药质量体系的管理评审4．2制药质量体系的内外部影响因素的监控4．3管理评审和监控成果5．术语附件1：基于法规方法对科学和风险进行改进的潜在机会附件2：ICH Q10 制药质量体系模型图PHARMACEUTICAL QUALITY SYSTEM药物质量体系1. PHARMACEUTICAL QUALITY SYSTEM 药物质量体系1.1 Introduction 介绍This document establishes a new ICH tripartite guideline describing a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. Throughout this guidelin e, the term “pharmaceutical quality system” refers to the ICH Q10 model.本文确立了新的ICH三方指南，叙述了制药工业有效质量管理体系的一个模型，被称之为制药质量体系。

Ningbo XXX Material TechnologyCo.,LtdISO9001:2015 Quality ManualRevision [A/0] - [2018/3/1](c) [Copyright Year Of 2018] [Ningbo XXX Material Technology Co.,Ltd]; all rights reserved. This document may contain proprietary information and may only be released to third parties with approval of management. Document is uncontrolled unless otherwise marked; uncontrolled documents are not subject to update notification.Revision [A/0] - [2018/3/1]Page 1 of 19TABLE OF CONTENTS0.0 Revision History and Approval ...................................................................................................................... 3 1.0 Welcome to Ningbo XXX Material Technology Co.,Ltd ................................................................................ 4 2.0 XXX Material: Who We Are ........................................................................................................................... 4 2.1 Determining Our Strategic Direction ......................................................................................................... 4 2.2 Scope of the Management System ........................................................................................................... 4 2.2.1 Scope Statement ............................................................................................................................... 4 2.2.2 Facilities Within the Scope ................................................................................................................ 4 2.2.3 Permissible Exclusions ..................................................................................................................... 5 2.2.4 Scope of the ISO9001:2015 Quality Manual ..................................................................................... 5 3.0 Quality Policy................................................................................................................................................. 5 4.0 Management System Structure and Controls ............................................................................................... 5 4.1 Process Approach .................................................................................................................................... 5 4.1.1 Process Identification ........................................................................................................................ 5 4.1.2 Process Controls & Objectives .......................................................................................................... 6 4.1.3 Outsourced Processes ...................................................................................................................... 7 4.2 Documentation & Records ....................................................................................................................... 7 4.2.1 General .............................................................................................................................................. 7 4.2.2 Control of Documents ....................................................................................................................... 7 4.2.3 Control of Records ............................................................................................................................ 7 4.3 Change Management ................................................................................................................................ 8 4.4 Risks and Opportunities ............................................................................................................................ 8 5.0 Management & Leadership ........................................................................................................................... 8 5.1 Management Leadership and Commitment .............................................................................................. 8 5.2 Customer Focus ........................................................................................................................................ 9 5.3 Quality Policy ............................................................................................................................................. 9 5.4 Organizational Roles Responsibilities & Authorities ................................................................................. 9 5.5 Internal Communication ............................................................................................................................ 9 5.6 Management Review .............................................................................................................................. 10 6.0 Resources ................................................................................................................................................... 10 6.1 Provision of Resources ........................................................................................................................... 10 6.2 Human Resources .................................................................................................................................. 10 6.3 Infrastructure ........................................................................................................................................... 11 6.4 Work Environment ................................................................................................................................... 11 6.5 Organizational Knowledge ...................................................................................................................... 11 7.0 Operation ..................................................................................................................................................... 11 7.1 Operational Planning and Control ........................................................................................................... 12 7.2 Customer-Related Activities .................................................................................................................... 12 7.2.1 Capture of Customer Requirements ............................................................................................... 12 7.2.2 Review of Customer Requirements ................................................................................................ 12 7.2.3 Customer Communication ............................................................................................................... 12 7.3 Design and Development ........................................................................................................................ 13 7.4 Purchasing .............................................................................................................................................. 13 7.5 Provision of [Production of adhesive tape] .............................................................................................. 13 7.5.1 Control of Provision of [Production of adhesive tape] ..................................................................... 13 7.5.2 Identification and Traceability .......................................................................................................... 14 7.5.3 Property Belonging to Third Parties ................................................................................................ 14 7.5.4 Preservation .................................................................................................................................... 14 7.5.5 Post-Delivery Activities .................................................................................................................... 14 7.5.6 Process Change Control ................................................................................................................. 15 7.5.7 Measurement and Release of [Production of adhesive tape] ......................................................... 15 7.5.8 Control of Nonconforming Outputs .. (15)Revision [A/0] - [2018/3/1]Page 2 of 198.0 Improvement ............................................................................................................................................... 15 8.1 General .................................................................................................................................................... 15 8.2 Customer Satisfaction ............................................................................................................................. 15 8.3 Internal Audit ........................................................................................................................................... 16 8.4 Corrective and Preventive Action ............................................................................................................ 16 Appendix A: Overall Process Sequence & Interaction ........................................................................................ 17 Appendix B: ISO 9001:2015 Cross Reference . (18)Revision [A/0] - [2018/3/1] 0.0 Revision History and ApprovalRev. Nature of changes Approval DateA/0 Original release. XXX 2018/3/1Page 3 of 19Revision [A/0] - [2018/3/1] 1.0 Welcome to Ningbo XXX Material Technology Co.,LtdNingbo XXX Material Technology Co., Ltd. Was established in 2000, with the UAE businessmen to build the joint venture company; 2004 Ming Shan founded Nissin special adhesive tape and adhesive tape company; 2008 due to the strategic adjustment of 3 company merger and reorganization, the establishment of Ningbo letter mountains adhesive products Manufacturing Co., Ltd..PVC insulation tape is one of China’s national standard drafting unit, the field of adhesive products governing unit of China, Ningbo, adhesives and related products Industry Association, honorary president of the unit.We produce more than 1000 varieties of products of 11 categories. The annual throughput more than 100,000,000 square of the adhesive and 10,000 ton of the adhesive.Our company located in Ningbo which the city of the east China sea, beside 500 kilometers of shanghai, 20 kilometers from Ningbo list airport and 50 kilograms of the Ningbo seaport. The transport is very convenient (Easy to ship to everywhere on the world).2.0 XXX Material: Who We Are2.1 Determining Our Strategic DirectionXXX Material has reviewed and analyzed key aspects of itself and its stakeholders to determine the strategic direction of the company. This involves:∙Understanding our core products and services, and scope of management system (see 2.2 below).∙Identifying “interested parties” (stakeholders) who receive our [Production of adhesive tape], or who may be impacted by them, or those parties who may otherwise have a significant interest in our company. These parties are identified in the document [Requirements and expectations list of interested parties].∙Understanding internal and external issues that are of concern to XXX Material and its interested parties; also identified in the document [Requirements and expectations list of interested parties]. Many such issues are identified through an analysis of risks facing either XXX Material or the interested parties. Such issues are monitored and updated as appropriate, and discussed as part of management reviews.This information is then used by senior management to determine the company’s strategic direction. This is defined in records of management review, and periodically updated as conditions and situations change.2.2 Scope of the Management System2.2.1 Scope StatementBased on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its products and services, XXX Material has determined the scope of the management system as follows:Production of adhesive tapePage 4 of 19Revision [A/0] - [2018/3/1]Page 5 of 192.2.2 Facilities Within the ScopeThe quality system applies to all processes, activities and employees within the company. The facility is located at: Factory Add ：XXX Tel ：XXX Fax ：XXX XXX XXX2.2.3 Permissible ExclusionsThe following clauses of ISO 9001 were determined to be not applicable to XXX Material.∙ 8.3 Design and development of products and services 2.2.4Scope of the ISO9001：2015 Quality ManualThis manual is prepared for the purpose of defining the company’s interpretations of the ISO 9001:2015 international standard, as well as to demonstrate how the company complies with that standard.This manual does not follow the numbering structure of ISO 9001. Instead, Appendix B presents a cross reference between the sections of this manual and the clauses of ISO 9001:2015.This manual presents “Notes” which are used to define how XXX Material has tailored its management system to suit its purposes. These are intended to clarify implementation approaches and interpretations for concepts which are not otherwise clearly defined in ISO 9001:2015. Notes appear in italics, with gray background.Where subordinate or supporting documentation is reference in this manual, these are indicated by bold italics .∙ Quality PolicyThe Quality Policy of XXX Material is as follows:Quality first, customer satisfaction;Scientific management, continuous improvement. ∙ Management SystemStructure and Controls 4.1Process Approach4.1.1 Process IdentificationXXX Material has adopted a process approach for its management system. By identifying thetop-level processes within the company, and then managing each of these discretely, this reduces the potential for nonconforming [Production of adhesive tape] discovered during final processes or after delivery. Instead, nonconformities and risks are identified in real time, by actions taken within each of the top-level processes.Note: not all activities are considered “processes” – the term “process” in this context indicates the activity has been elevated to a higher level of control and management oversight.The controls indicated herein are applicable only to the top-level processes identified.。

Ref. Ares(2012)778531 - 28/06/2012 EUROPEAN COMMISSIONHEALTH AND CONSUMERS DIRECTORATE-GENERALHealth Systems and ProductsMedicinal Products - Quality, safety and efficacyBrussels,SANCO/AM/sl/ddg1.d.6(2012)860362EudraLexThe Rules Governing Medicinal Products in the European UnionVolume 4EU Guidelines forGood Manufacturing Practice forMedicinal Products for Human and Veterinary UseChapter 7Outsourced ActivitiesLegal basis for publishing the detailed guidelines: Article 47 of Directive2001/83/EC on the Community code relating to medicinal products for human use andArticle 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinalproducts as laid down in Directive 2003/94/EC for medicinal products for human useand Directive 91/412/EEC for veterinary use.Status of the document: revision 1Reasons for changes: In view of the ICH Q10 guideline on the PharmaceuticalQuality System, Chapter 7 of the GMP Guide has been revised in order to provideupdated guidance on outsourced GMP regulated activities beyond the current scope ofcontract manufacture and analysis operations. The title of the Chapter has beenchanged to reflect this.Deadline for coming into operation: 31 January 2013Commission Européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel – Belgium. Telephone: (32-2) 299 11 11 PrincipleAny activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality. There must be a written Contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party. The Quality Management System of the Contract Giver must clearly state the way that the Qualified Person certifying each batch of product for release exercises his full responsibility.Note: This Chapter deals with the responsibilities of manufacturers towards the Competent Authorities of the Member States with respect to the granting of marketing and manufacturing authorizations. It is not intended in any way to affect the respective liability of Contract Acceptors and Contract Givers to consumers; this is governed by other provisions of Community and national law.General7.1 There should be a written Contract covering the outsourced activities, theproducts or operations to which they are related, and any technical arrangements made in connection with it.7.2 All arrangements for the outsourced activities including any proposed changesin technical or other arrangements should be in accordance with regulations in force, and the Marketing Authorisation for the product concerned, where applicable.7.3 Where the marketing authorization holder and the manufacturer are not thesame, appropriate arrangements should be in place, taking into account the principles described in this chapter.The Contract Giver7.4 The pharmaceutical quality system of the Contract Giver should include thecontrol and review of any outsourced activities. The Contract Giver is ultimately responsible to ensure processes are in place to assure the control of outsourced activities. These processes should incorporate quality risk management principles and notably include:7.5 Prior to outsourcing activities, the Contract Giver is responsible for assessingthe legality, suitability and the competence of the Contract Acceptor to carry out successfully the outsourced activities. The Contract Giver is also responsible for ensuring by means of the Contract that the principles and guidelines of GMP as interpreted in this Guide are followed.7.6 The Contract Giver should provide the Contract Acceptor with all theinformation and knowledge necessary to carry out the contracted operations correctly in accordance with regulations in force, and the Marketing Authorisation for the product concerned. The Contract Giver should ensure that the Contract Acceptor isfully aware of any problems associated with the product or the work which might pose a hazard to his premises, equipment, personnel, other materials or other products.7.7 The Contract Giver should monitor and review the performance of the Contract Acceptor and the identification and implementation of any needed improvement.7.8 The Contract Giver should be responsible for reviewing and assessing the records and the results related to the outsourced activities. He should also ensure, either by himself, or based on the confirmation of the Contract Acceptor’s Qualified Person, that all products and materials delivered to him by the Contract Acceptor have been processed in accordance with GMP and the marketing authorisation.The Contract Acceptor7.9 The Contract Acceptor must be able to carry out satisfactorily the work ordered by the Contract Giver such as having adequate premises, equipment, knowledge, experience, and competent personnel.7.10 The Contract Acceptor should ensure that all products, materials and knowledge delivered to him are suitable for their intended purpose.7.11 The Contract Acceptor should not subcontract to a third party any of the work entrusted to him under the Contract without the Contract Giver’s prior evaluation and approval of the arrangements. Arrangements made between the Contract Acceptor and any third party should ensure that information and knowledge, including those from assessments of the suitability of the third party, are made available in the same way as between the original Contract Giver and Contract Acceptor.7.12 The Contract Acceptor should not make unauthorized changes, outside the terms of the Contract, which may adversely affect the quality of the outsourced activities for the Contract Giver.7.13 The Contract Acceptor should understand that outsourced activities, including contract analysis, may be subject to inspection by the competent authorities.The Contract7.14 A Contract should be drawn up between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities and communication processes relating to the outsourced activities. Technical aspects of the Contract should be drawn up by competent persons suitably knowledgeable in related outsourced activities and Good Manufacturing Practice. All arrangements for outsourced activities must be in accordance with regulations in force and the Marketing Authorisation for the product concerned and agreed by both parties.7.15 The Contract should describe clearly who undertakes each step of the outsourced activity, e.g. knowledge management, technology transfer, supply chain, subcontracting, quality and purchasing of materials, testing and releasing materials,undertaking production and quality controls (including in-process controls, sampling and analysis).7.16 All records related to the outsourced activities, e.g. manufacturing, analytical and distribution records, and reference samples, should be kept by, or be available to, the Contract Giver. Any records relevant to assessing the quality of a product in the event of complaints or a suspected defect or to investigating in the case of a suspected falsified product must be accessible and specified in the relevant procedures of the Contract Giver.7.17 The Contract should permit the Contract Giver to audit outsourced activities, performed by the Contract Acceptor or his mutually agreed subcontractors。

PEC电子工程英语证书考试-电子工业常用词汇Approved vendor list (A VL): a listing of all approved sources, in addition to part descriptions and part numbers.Bill of materials (BOM): a comprehensive listing of all components and subassemblies that go into a specific product, showing the quantity of each required to assemble the item.Box-build: a term commonly used to describe assembly work other than printed circuit board (PCB) production. The electromechanical assembly process involves enclosure fabrication, installation of subassemblies and components, and routing of cabling or wire harnesses.Contract manufacturing: production of products on behalf of an OEM, in which the design and brand name belongs to the OEM. Contract manufacturers have made it possible for some companies to operate without owning any brick-and-mortar factories. Price pressure and the need for global product expansion are driving the growth of contract manufacturing. Any contract manufacturer should provide an advantage that isn't already part of the OEM's infrastructure. Also see "electronics manufacturing services" and "outsourcing."Contract manufacturer (CM): a company that engages in product assembly, engineering services, order fulfillment and product distribution. A CM usually works on behalf of an OEM. However, OEMs can also function as contract manufacturers.Core competencies: activities or practices, such as product development, deemed by a company as critical to its long-term success and growth. Typically, core competencies are based on skills or knowledge sets rather than products or functions. They provide return on investment and act as a barrier for other companies trying to enter the market. Many manufacturers choose to focus on core competencies and outsource production tasks. Most OEMs plan to keep their high-level engineering and design work as internal competencies, particularly as they apply to new products and high-end products.Corrective action request (CAR): an action item that surfaces whereby the requesting party (either the OEM or EMS provider) asks the party responsible to conduct a root cause analysis and resolve the issue identified.Electronics manufacturing services (EMS): an industry based on providing contract design, manufacturing and product support services on behalf of OEMs. Traditional services include PCB assembly, box-build and testing. Today, EMS providers are also providing numerous services such as supply chain management, global distribution, logistics, customer support and repair. However, all intellectual property belongs to the OEM. Also see "contract manufacturing" and "outsourcing."Engineering change order (ECO): an alteration made to an A VL or BOM, such as the replacement of one component by a substitute component. Any changes should be prepared, approved and incorporated promptly and correctly to minimize problems. Changes often vary in complexity and urgency, but can have a ripple effect. Any ECO should be documented on a blank form or template that contains key information, such as a description of change, a reason for the change, the type of change and the implementation date (e.g., immediate action or implement when possible).First-pass yield (FPY): the percentage of product tested that passed inspection on first attempt.High-mix, low-volume: a contract manufacturing environment where the products being assembled vary in application, lot size and production processes. Contract manufacturers that are equipped for high-mix, low-volume production have the ability to change over product requirements and convert assembly lines in a matter of hours. They can easily add capacity to accommodate increased volume and rapid throughput cycles. However, high-mix, low-volume manufacturing creates numerous challenges because there are more areas to invite error. Lower quantities demand more frequent changeover and may only last several shifts or days.Intellectual property (IP): any product of the human intellect that is unique, novel and unobvious, and has some value in the marketplace. It includes ideas, inventions, business methods and manufacturing processes.Joint design manufacturer (JDM): a company that helps design products for OEM customers. However, distinction on who owns the intellectual property is murky and can surface as licensing problems.Joint service agreement (JSA): a document used in conjunction with a contract to define the processes, performance targets and expectations of both an OEM and a contract manufacturer. The joint service agreement should be specific in terms of how the work will be done and evaluated. It should be supplemented by a management control system that requires a regular review of performance against the JSA expectations. This approach helps minimize the misunderstandings that often develop in outsourcing relationships. Also see "manufacturing and supply agreement."Low-mix, high-volume: a contract manufacturing environment where there are a few number of assemblies produced in large quantities. High-volume production may last for weeks or months using the same setup. Changeover is at a minimum and equipment utilization is very high. Contract manufacturers are at their most efficient when running at high volumes, with minimal engineering changes.Manufacturing and supply agreement (MSA): a contract that defines responsibilities and bridges the relationship between an OEM and a contract manufacturer. It outlines what the EMS provider is required to do for the OEM and at what "cost" to the provider. It also details what the OEM will receive from the provider and at what "price." An MSA addresses pricing for both current and new products, inventory liability, and performance and service expectations. Also see "joint service agreement."Medium-mix, medium-volume: a contract manufacturing environment where production volumes remain relatively stable for an extended period of time. Medium-volume production may last for days or weeks using the same setup.New product introduction (NPI): a set of integrated processes used to convert a product design into a manufacturing-ready product while meeting cost, quality and time-to-market objectives.Nonrecurring expense (NRE): items and activities required by an EMS provider specific to a particular OEM's product program, such as setup, tooling and programming. These one-time charges are separate from the product cost.Original equipment manufacturer (OEM): a company that designs and specifies products under its own company name and brand. Traditionally, OEMs design products, purchase components from suppliers, operate their own manufacturing plants, and handle sales, service and support activities, but many of those functions are being outsourced today.Outsourcing: the process of subcontracting a process, such as product design or manufacturing, to a third-party company. Outsourcing to EMS providers has traditionally appealed to makers of computers, telecommunications hardware and other electronic items. However, outsourcing also is becoming a cost-effective option for manufacturers of fiber optic components and medical devices. Many companies outsource older, more stable product lines so they can focus operations on newer, more technically complex products with higher profit margins. Also see "contract manufacturing" and "electronics manufacturing services."Reflow Soldering: a process of using heated air or infrared lamps to melt solder paste on the assembled PCB for SMT devices at once.Request for quote (RFQ): a document that is prepared by the OEM and submitted to the EMS provider for quotation. It typically includes product specifications and quantities, in addition to an A VL and BOM. The RFQ should also include key elements the OEM will request of the contract manufacturer in the MSA, such as inventory liabilities.Time to market: the length of time it takes to get a quality product into the marketplace. Faster time to market is a critical business objective for all manufacturers. Companies in every industry are using speed as a competitive weapon. The goal is to get to market with a new product (or a better quality product) quicker than anyone else. Being the first to market can increase a company's profit margin and its market share.Solder Paste Stencil: a steel or brass plate, typically 5mils thick, that is placed over the bare PCB. Solder paste is then wiped across its surface depositing paste through the openings and then removed. This process is used for reflow soldering.V olume price agreement (VPA): a contract service agreement containing pricing, deliverables and cost reductions based on volume manufacturing.Wave Soldering: a process where an assembled PCB is drawn over the surface of a large pool of molten solder thereby soldering all devices at once, this process can be used for SMT and thru-hole components.。

II(Information)INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICESAND AGENCIESOTHER ACTSGuidelinesof 7 March 2013on Good Distribution Practice of Medicinal Products for Human Use(2013/C 68/01)INTRODUCTIONThese guidelines are based on Article 84 and Article 85(b)(3) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (1) (Directive 2001/83/EC).The wholesale distribution of medicinal products is an important activity in integrated supply chain management. Today’s distribution network for medicinal products is increasingly complex and involves many players. These guidelines lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain. Compliance with these guidelines will ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products.According to Article 1(17) of Directive 2001/83/EC, wholesale distribution of medicinal products is all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depos­itories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned.Any person acting as a wholesale distributor has to hold a wholesale distribution authorisation. Article 80(g) of Directive 2001/83/EC provides that distributors must comply with the principles of and guidelines for good distribution practice (GDP). Possession of a manufacturing authorisation includes author­isation to distribute the medicinal products covered by the au­thorisation. Manufacturers performing any distribution activities with their own products must therefore comply with GDP.The definition of wholesale distribution does not depend on whether that distributor is established or operating in specific customs areas, such as in free zones or in free warehouses. All obligations related to wholesale distribution activities (such as exporting, holding or supplying) also apply to these distributors. Relevant sections of these guidelines should also be adhered to by other actors involved in the distribution of medicinal products.Other actors such as brokers may also play a role in the distribution channel for medicinal products. According to Article 85(b), persons brokering medicinal products must be subject to certain provisions applicable to wholesale distributors, as well as specific provisions on brokering.CHAPTER 1 — QUALITY MANAGEMENT1.1. PrincipleWholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities (2). All distribution activities should be clearly defined and systematically reviewed. All critical steps of distribution processes and significant changes should be justified and where relevant validated. The quality system is the responsibility of the organisation’s management and requires their leadership and active participation and should be supported by staff commitment.(1) OJ L 311, 28.11.2001, p. 67. (2) Article 80(h) of Directive 2001/83/EC.1.2. Quality systemThe system for managing quality should encompass the organ­isational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that the product delivered maintains its quality and integrity and remains within the legal supply chain during storage and/or transportation.The quality system should be fully documented and its effecti­veness monitored. All quality system-related activities should be defined and documented. A quality manual or equivalent docu­mentation approach should be established.A responsible person should be appointed by the management, who should have clearly specified authority and responsibility for ensuring that a quality system is implemented and maintained.The management of the distributor should ensure that all parts of the quality system are adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.The size, structure and complexity of distributor’s activities should be taken into consideration when developing or modifying the quality system.A change control system should be in place. This system should incorporate quality risk management principles, and be proportionate and effective.The quality system should ensure that:(i) medicinal products are procured, held, supplied or exportedin a way that is compliant with the requirements of GDP;(ii) management responsibilities are clearly specified;(iii) products are delivered to the right recipients within a satisfactory time period;(iv) records are made contemporaneously;(v) deviations from established procedures are documented and investigated;(vi) appropriate corrective and preventive actions (commonly known as CAPA) are taken to correct deviations and prevent them in line with the principles of quality risk management.1.3. Management of outsourced activitiesThe quality system should extend to the control and review of any outsourced activities related to the procurement, holding, supply or export of medicinal products. These processes should incorporate quality risk management and include:(i) assessing the suitability and competence of the ContractAcceptor to carry out the activity and checking authorisation status, if required;(ii) defining the responsibilities and communication processes for the quality-related activities of the parties involved;(iii) monitoring and review of the performance of the Contract Acceptor, and the identification and implementation of any required improvements on a regular basis.1.4. Management review and monitoringThe management should have a formal process for reviewing the quality system on a periodic basis. The review should include:(i) measurement of the achievement of quality systemobjectives;(ii) assessment of performance indicators that can be used to monitor the effectiveness of processes within the quality system, such as complaints, deviations, CAPA, changes to processes; feedback on outsourced activities; self-assessment processes including risk assessments and audits; and external assessments such as inspections, findings and customer audits;(iii) emerging regulations, guidance and quality issues that can impact the quality management system;(iv) innovations that might enhance the quality system;(v) changes in business environment and objectives.The outcome of each management review of the quality system should be documented in a timely manner and effectively communicated internally.1.5. Quality risk managementQuality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of medicinal products. It can be applied both proactively and retrospectively.Quality risk management should ensure that the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient. The level of effort, formality and documentation of the process should be commensurate with the level of risk. Examples of the processes and applications of quality risk management can be found in guideline Q9 of the International Conference on Harmonisation (ICH).CHAPTER 2 — PERSONNEL2.1. PrincipleThe correct distribution of medicinal products relies upon people. For this reason, there must be sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible. Individual responsibilities should be clearly understood by the staff and be recorded.2.2. Responsible personThe wholesale distributor must designate a person as Responsible Person. The Responsible Person should meet the qualifications and all conditions provided for by the legislation of the Member State concerned (1). A degree in pharmacy is desirable. The Responsible Person should have appropriate competence and experience as well as knowledge of and training in GDP.The Responsible Person should fulfil their responsibilities personally and should be continuously contactable. The Responsible Person may delegate duties but not responsibilities.The written job description of the Responsible Person should define their authority to take decisions with regard to their responsibilities. The wholesale distributor should give the Responsible Person the defined authority, resources and responsibility needed to fulfil their duties.The Responsible Person should carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.The responsibilities of the Responsible Person include:(i) ensuring that a quality management system isimplemented and maintained;(ii) focusing on the management of authorised activities and the accuracy and quality of records;(iii) ensuring that initial and continuous training programmes are implemented and maintained;(iv) coordinating and promptly performing any recall operations for medicinal products;(v) ensuring that relevant customer complaints are dealt with effectively;(vi) ensuring that suppliers and customers are approved;(vii) approving any subcontracted activities which may impact on GDP;(viii) ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;(ix) keeping appropriate records of any delegated duties;(x) deciding on the final disposition of returned, rejected, recalled or falsified products;(xi) approving any returns to saleable stock;(xii) ensuring that any additional requirements imposed on certain products by national law are adhered to (2).2.3. Other personnelThere should be an adequate number of competent personnel involved in all stages of the wholesale distribution activities of medicinal products. The number of personnel required will depend on the volume and scope of activities.The organisational structure of the wholesale distributor should be set out in an organisation chart. The role, responsibilities, and interrelationships of all personnel should be clearly indicated.The role and responsibilities of employees working in key positions should be set out in written job descriptions, along with any arrangements for deputising.2.4. TrainingAll personnel involved in wholesale distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks.Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme. The Responsible Person should also maintain their competence in GDP through regular training.(1) Article 79(b) of Directive 2001/83/EC. (2) Article 83 of Directive 2001/83/EC.In addition, training should include aspects of product identifi­cation and avoidance of falsified medicines entering the supply chain.Personnel dealing with any products which require more stringent handling conditions should receive specific training. Examples of such products include hazardous products, radio­active materials, products presenting special risks of abuse (including narcotic and psychotropic substances), and temperature-sensitive products.A record of all training should be kept, and the effectiveness of training should be periodically assessed and documented.2.5. HygieneAppropriate procedures relating to personnel hygiene, relevant to the activities being carried out, should be established and observed. Such procedures should cover health, hygiene and clothing.CHAPTER 3 — PREMISES AND EQUIPMENT3.1. PrincipleWholesale distributors must have suitable and adequate premises, installations and equipment (1), so as to ensure proper storage and distribution of medicinal products. In particular, the premises should be clean, dry and maintained within acceptable temperature limits.3.2. PremisesThe premises should be designed or adapted to ensure that the required storage conditions are maintained. They should be suitably secure, structurally sound and of sufficient capacity to allow safe storage and handling of the medicinal products. Storage areas should be provided with adequate lighting to enable all operations to be carried out accurately and safely.Where premises are not directly operated by the wholesale distributor, a contract should be in place. The contracted premises should be covered by a separate wholesale distribution authorisation.Medicinal products should be stored in segregated areas which are clearly marked and have access restricted to authorised personnel. Any system replacing physical segregation, such as electronic segregation based on a computerised system, should provide equivalent security and should be validated.Products pending a decision as to their disposition or products that have been removed from saleable stock should be segregated either physically or through an equivalent electronic system. This includes, for example, any product suspected of falsification and returned products. Medicinal products received from a third country but not intended for the Union market should also be physically segregated. Any falsified medicinal products, expired products, recalled products and rejected products found in the supply chain should be immediately physically segregated and stored in a dedicated area away from all other medicinal products. The appropriate degree of security should be applied in these areas to ensure that such items remain separate from saleable stock. These areas should be clearly identified.Special attention should be paid to the storage of products with specific handling instructions as specified in national law. Special storage conditions (and special authorisations) may be required for such products (e.g. narcotics and psychotropic substances).Radioactive materials and other hazardous products, as well as products presenting special safety risks of fire or explosion (e.g. medicinal gases, combustibles, flammable liquids and solids), should be stored in one or more dedicated areas subject to local legislation and appropriate safety and security measures.Receiving and dispatch bays should protect products from prevailing weather conditions. There should be adequate separation between the receipt and dispatch and storage areas. Procedures should be in place to maintain control of inbound/ outbound goods. Reception areas where deliveries are examined following receipt should be designated and suitably equipped.Unauthorised access to all areas of the authorised premises should be prevented. Prevention measures would usually include a monitored intruder alarm system and appropriate access control. Visitors should be accompanied.Premises and storage facilities should be clean and free from litter and dust. Cleaning programmes, instructions and records should be in place. Appropriate cleaning equipment and cleaning agents should be chosen and used so as not to present a source of contamination.Premises should be designed and equipped so as to afford protection against the entry of insects, rodents or other animals. A preventive pest control programme should be in place.Rest, wash and refreshment rooms for employees should be adequately separated from the storage areas. The presence of food, drink, smoking material or medicinal products for personal use should be prohibited in the storage areas.(1) Article 79(a) of Directive 2001/83/EC.3.2.1. Temperature and environment controlSuitable equipment and procedures should be in place to check the environment where medicinal products are stored. Environ­mental factors to be considered include temperature, light, humidity and cleanliness of the premises.An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions. Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations. The mapping exercise should be repeated according to the results of a risk assessment exercise or whenever significant modifications are made to the facility or the temperature controlling equipment. For small premises of a few square meters which are at room temperature, an assessment of potential risks (e.g. heaters) should be conducted and temperature monitors placed accordingly.3.3. EquipmentAll equipment impacting on storage and distribution of medicinal products should be designed, located and maintained to a standard which suits its intended purpose. Planned main­tenance should be in place for key equipment vital to the functionality of the operation.Equipment used to control or to monitor the environment where the medicinal products are stored should be calibrated at defined intervals based on a risk and reliability assessment.Calibration of equipment should be traceable to a national or international measurement standard. Appropriate alarm systems should be in place to provide alerts when there are excursions from predefined storage conditions. Alarm levels should be appropriately set and alarms should be regularly tested to ensure adequate functionality.Equipment repair, maintenance and calibration operations should be carried out in such a way that the integrity of the medicinal products is not compromised.Adequate records of repair, maintenance and calibration activities for key equipment should be made and the results should be retained. Key equipment would include for example cold stores, monitored intruder alarm and access control systems, refrigerators, thermo hygrometers, or other temperature and humidity recording devices, air handling units and any equipment used in conjunction with the onward supply chain. 3.3.1. Computerised systemsBefore a computerised system is brought into use, it should be demonstrated, through appropriate validation or verification studies, that the system is capable of achieving the desired results accurately, consistently and reproducibly.A written, detailed description of the system should be available (including diagrams where appropriate). This should be kept up to date. The document should describe principles, objectives, security measures, system scope and main features, how the computerised system is used and the way it interacts with other systems.Data should only be entered into the computerised system or amended by persons authorised to do so.Data should be secured by physical or electronic means and protected against accidental or unauthorised modifications. Stored data should be checked periodically for accessibility. Data should be protected by backing up at regular intervals. Backup data should be retained for the period stated in national legislation but at least 5 years at a separate and secure location.Procedures to be followed if the system fails or breaks down should be defined. This should include systems for the restoration of data.3.3.2. Qualification and validationWholesale distributors should identify what key equipment qualification and/or key process validation is necessary to ensure correct installation and operation. The scope and extent of such qualification and/or validation activities (such as storage, pick and pack processes) should be determined using a documented risk assessment approach.Equipment and processes should be respectively qualified and/or validated before commencing use and after any significant changes (e.g. repair or maintenance).Validation and qualification reports should be prepared summarising the results obtained and commenting on any observed deviations. Deviations from established procedures should be documented and further actions decided to correct deviations and avoid their reoccurrence (corrective and preventive actions). The principles of CAPA should be applied where necessary. Evidence of satisfactory validation and acceptance of a process or piece of equipment should be produced and approved by appropriate personnel.CHAPTER 4 — DOCUMENTATION4.1. PrincipleGood documentation constitutes an essential part of the quality system. Written documentation should prevent errors from spoken communication and permits the tracking of relevant operations during the distribution of medicinal products.4.2. GeneralDocumentation comprises all written procedures, instructions, contracts, records and data, in paper or in electronic form. Documentation should be readily available/retrievable.With regard to the processing of personal data of employees, complainants or any other natural person, Directive 95/46/EC on the protection of individuals applies to the processing of personal data and to the free movement of such data.Documentation should be sufficiently comprehensive with respect to the scope of the wholesale distributor’s activities and in a language understood by personnel. It should be written in clear, unambiguous language and be free from errors.Procedures should be approved signed and dated by the responsible person. Documentation should be approved, signed and dated by appropriate authorised persons, as required. It should not be handwritten; although, where it is necessary, sufficient space should be provided for such entries.Any alteration made in the documentation should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.Documents should be retained for the period stated in national legislation but at least 5 years. Personal data should be deleted or anonymised as soon as their storage is no longer than necessary for the purpose of distribution activities.Each employee should have ready access to all necessary documentation for the tasks executed.Attention should be paid to using valid and approved procedures. Documents should have unambiguous content; title, nature and purpose should be clearly stated. Documents should be reviewed regularly and kept up to date. Version control should be applied to procedures. After revision of a document a system should exist to prevent inadvertent use of the superseded version. Superseded or obsolete procedures should be removed from workstations and archived. Records must be kept either in the form of purchase/sales invoices, delivery slips, or on computer or any other form, for any transaction in medicinal products received, supplied or brokered.Records must include at least the following information: date; name of the medicinal product; quantity received, supplied or brokered; name and address of the supplier, customer, broker or consignee, as appropriate; and batch number at least for medicinal product bearing the safety features (1).Records should be made at the time each operation is undertaken.CHAPTER 5 — OPERATIONS5.1. PrincipleAll actions taken by wholesale distributors should ensure that the identity of the medicinal product is not lost and that the wholesale distribution of medicinal products is performed according to the information on the outer packaging. The wholesale distributor should use all means available to minimise the risk of falsified medicinal products entering the legal supply chain.All medicinal products distributed in the EU by a wholesale distributor must be covered by a marketing authorisation granted by the EU or by a Member State (2).Any distributor, other than the marketing authorisation holder, who imports a medicinal product from another Member State must notify the marketing authorisation holder and the competent authority in the Member State to which the medicinal product will be imported of their intention to import that product (3). All key operations described below should be fully described in the quality system in appropriate documentation.5.2. Qualification of suppliersWholesale distributors must obtain their supplies of medicinal products only from persons who are themselves in possession of a wholesale distribution authorisation, or who are in possession of a manufacturing authorisation which covers the product in question (4).Wholesale distributors receiving medicinal products from third countries for the purpose of importation, i.e. for the purpose of placing these products on the EU market, must hold a manufacturing authorisation (5).(1) Articles 80(e) and 82 of Directive 2001/83/EC.(2) Articles 76(1) and) (2) of Directive 2001/83/EC.(3) Article 76(3) of Directive 2001/83/EC.(4) Article 80(b) of Directive 2001/83/EC.(5) Article 40, third paragraph of Directive 2001/83/EC.Where medicinal products are obtained from another wholesale distributor the receiving wholesale distributor must verify that the supplier complies with the principles and guidelines of good distribution practices and that they hold an authorisation for example by using the Union database. If the medicinal product is obtained through brokering, the wholesale distributor must verify that the broker is registered and complies with the requirements in Chapter 10 (1).Appropriate qualification and approval of suppliers should be performed prior to any procurement of medicinal products. This should be controlled by a procedure and the results documented and periodically rechecked.When entering into a new contract with new suppliers the wholesale distributor should carry out ‘due diligence’ checks in order to assess the suitability, competence and reliability of the other party. Attention should be paid to:(i) the reputation or reliability of the supplier;(ii) offers of medicinal products more likely to be falsified;(iii) large offers of medicinal products which are generally only available in limited quantities; and(iv) out-of-range prices.5.3. Qualification of customersWholesale distributors must ensure they supply medicinal products only to persons who are themselves in possession of a wholesale distribution authorisation or who are authorised or entitled to supply medicinal products to the public.Checks and periodic rechecks may include: requesting copies of customer’s authorisations according to national law, verifying status on an authority website, requesting evidence of qualifications or entitlement according to national legislation.Wholesale distributors should monitor their transactions and investigate any irregularity in the sales patterns of narcotics, psychotropic substances or other dangerous substances. Unusual sales patterns that may constitute diversion or misuse of medicinal product should be investigated and reported to competent authorities where necessary. Steps should be taken to ensure fulfilment of any public service obligation imposed upon them.5.4. Receipt of medicinal productsThe purpose of the receiving function is to ensure that the arriving consignment is correct, that the medicinal products originate from approved suppliers and that they have not been visibly damaged during transport.Medicinal products requiring special storage or security measures should be prioritised and once appropriate checks have been conducted they should be immediately transferred to appropriate storage facilities.Batches of medicinal products intended for the EU and EEA countries should not be transferred to saleable stock before assurance has been obtained in accordance with written procedures, that they are authorised for sale. For batches coming from another Member State, prior to their transfer to saleable stock, the control report referred to in Article 51(1) of Directive 2001/83/EC or another proof of release to the market in question based on an equivalent system should be carefully checked by appropriately trained personnel.5.5. StorageMedicinal products and, if necessary, healthcare products should be stored separately from other products likely to alter them and should be protected from the harmful effects of light, temperature, moisture and other external factors. Particular attention should be paid to products requiring specific storage conditions.Incoming containers of medicinal products should be cleaned, if necessary, before storage.Warehousing operations must ensure appropriate storage conditions are maintained and allow for appropriate security of stocks.Stock should be rotated according to the first expiry, first out (FEFO) principle. Exceptions should be documented.Medicinal products should be handled and stored in such a manner as to prevent spillage, breakage, contamination and mix-ups. Medicinal products should not be stored directly on the floor unless the package is designed to allow such storage (such as for some medicinal gas cylinders).Medicinal products that are nearing or are beyond their expiry date/shelf life should be withdrawn immediately from saleable stock either physically or through other equivalent electronic segregation.(1) Article 80, fourth paragraph of Directive 2001/83/EC.。

最新WHO986号技术报告GMP准则，第一章：质量体系(之一)，2014-10-18目录1. Pharmaceutical quality system 852. Good manufacturing practices for pharmaceutical products 903. Sanitation and hygiene 914. Qualification and validation 915. Complaints 926. Product recalls 937. Contract production, analysis and other activities 948. Self-inspection, quality audits and suppliers’ audits and approval 979. Personnel 9910. Training 10311. Personal hygiene 10312. Premises 10413. Equipment 10814. Materials 10915. Documentation 11516. Good practices in production 12517. Good practices in quality control 1291. Pharmaceutical quality system 制药质量体系1.1. Principle. The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy.原则：生产者必须承担制药产品的质量职责确保产品符合预期使用目的，符合上市许可的要求，不会因为安全性、质量或疗效的不足给患者造成风险。

世界是平的影评Outsourced第一篇：世界是平的影评OutsourcedOutsourced《世界是平的》If Ayesha Dharker and the Kamasutra are waiting for me on the other side, outsource me up, SpockNewcomer writer/director John Jeffcoat is *** a mini-splash with what could be the next big thing in “up the corporation” comedies.Even better, it is a romantic comedy with comely Ayesha Dharker providing the on-screen chemistry.Hamilton’s character Todd has graduated from college, probably like Hamilton’s previous character Grover in “Kicking and Screaming,” and has gravitated into the kind of dead end job that made “Office Space” famous.As in the latter flick, outsourcing is rearing its ugly head in the form of shipping customer service jobs to(where else?)India.As the film points out, everything that can be handled via phone or e-mail is being re-birthed on another continent and connected to the American pots of gold by satellite umbilicals.The workers T odd supervises will be the first to go and he will be next, that is, unless, he travels to India to train his replacement.So the plot goes, if he toes the line he will get his retirement and if he doesn’t he will live in a cardboard box.This is only the first of more than a few sophomoric mistakes made by Mr.Jeffcoat and co-writer George Wing, but we are given notice in the first few shots of dreamy Seattle that we are expected to suspend disbelief here(after all, it isn’t raining….).Traveling to India, Todd makes mistakes dumber than any of us ever made going anywhere overseas, even in high school.Of course, his boss is even dumber.But that’s not the point.The point is that even though his girlfriend has dumpedhim and is sleeping with another guy when he calls and his corporate structure treats him like an indentured servant he stills loves the USA.That is, until he meets Asha, played by seductive Dharker.Between Asha’s homework on the Kamasutra and a neighborhood full of Indians who look and act more like North Carolinians, Josh learns that maybe the best things in life aren’t stock options.Josh is going to train Purohit(Asif Basra)to be the next supervisor of the order fulfilment(sic)department that will soon have its one and only call center in a small town about a hundred miles from Bombay.The very repeating of the department title of “order fulfillment” becomes funny after a while, at least for those in the audience with the patience to let it grow on them.But the new position, paying mountains of rupees a year, is the promise of a dream come true for Purohit.He needs it to marry the love of his life;a love as dear as the love Todd lost while he was abandoning his stateside life in favor of a customer fulfillment career.So Asha is not only the symbol of a different perspective, a kinder gentler capitalism, but she is the start of something great.Parents never fear, the film treads lightly when it wonders anywhere near the ***ual.In one of the most amazing shows of modesty on the contemporary screen, Asha actually has clothes on in bed with Todd.The fact that she behaves more like a Hollywood starlet than a promised Indian bride will probably be glossed over by the average American watching the film.She is at least as virtuous as the girl next door.At least the girl next door in New York.Or Seattle.The film misses a couple great angles, like the 50” flat screen of Todd’s dreams to which Purohit is completely hip, but which never materializes.That would have been a great twist to have come back over the wall as Todd hands out his daily alm s.In the end, if everybody doesn’t get what theywant, they get what they need.The final twist is good hearted and clean-cut fun;as touchingas it is believable.What goes around comes around.第二篇：英文影评《世界是平的》(Outsourced)英文影评:《世界是平的》（Outsourced）If Ayesha Dharker and the Kamasutra are waiting for me on the other side, outsource me up, SpockNewcomer writer/director John Jeffcoat is making a mini-splash with what could be the next big thing in “up the corporation” comedies.Even better, it is a romantic comedy with comely Ayesha Dharker providing the on-screen chemistry.Hamilton’s character Todd has graduated from college, probably like Hamilton’s previous character Grover in “Kicking and Screaming,” and has gravitated into the kind of dead end job that made “Office Space” famous.As in the latter flick, outsourcing is rearing its ugly head in the form of shipping customer service jobs to(where else?)India.As the film points out, everything that can be handled via phone or e-mail is being re-birthed on another continent and connected to the American pots of gold by satellite umbilicals.The workers T odd supervises will be the first to go and he will be next, that is, unless, he travels to India to train his replacement.So the plot goes, if he toes the line he will get his retirement and if he doesn’t he will live in a cardboard box.This is only the first of more than a few sophomoric mistakes made by Mr.Jeffcoat and co-writer George Wing, but we are given notice in the first few shots of dreamy Seattle that we are expected to suspend disbelief here(after all, it isn’t raining….).Traveling to India, Todd makes mistakes dumber than any of us ever made going anywhere overseas, even in high school.Of course, his boss is even dumber.But that’s not thepoint.The point is that even though his girlfriend has dumped him and is sleeping with another guy when he calls and his corporate structure treats him like an indentured servant he stills loves the USA.That is, until he meets Asha, played by seductive Dharker.Between Asha’s homework on the Kamasutra and a neighborhood full of Indians who look and act more like North Carolinians, Josh learns that maybe the best things in life aren’t stock options.Josh is going to train Purohit(Asif Basra)to be the next supervisor of the order fulfilment(sic)department that will soon have its one and only call center in a small town about a hundred miles from Bombay.The very repeating of the department title of “order fulfillment” becomes funny after a while, at least for those in the audience with the patience to let it grow on them.But the new position, paying mountains of rupees a year, is the promise of a dream come true for Purohit.He needs it to marry the love of his life;a love as dear as the love Todd lost while he was abandoning his stateside life in favor of a customer fulfillment career.So Asha is not only the symbol of a different perspective, a kinder gentler capitalism, but she is the start of something great.Parents never fear, the film treads lightly when it wonders anywhere near the sexual.In one of the most amazing shows of modesty on the contemporary screen, Asha actually has clothes on in bed with Todd.The fact that she behaves more like a Hollywood starlet than a promised Indian bride will probably be glossed over by the average American watching the film.She is at least as virtuous as the girl next door.At least the girl next door in New York.Or Seattle.The film misses a couple great angles, like the 50” flat screen of Todd’s dreams to which Purohit is completely hip, but which never materializes.That would have been a great twist to have come back over the wall as Todd handsout his daily alms.In the end, if everybody doesn’t get what they want, they get what they need.The final twist is good hearted and clean-cut fun;as touching as it is believable.What goes around comes around.第三篇：世界是平的英文影评Review of “Outsourced”“Outsourced” is a typical fish-out-of-water tale about a young American telemarketer who learns that his job is being shipped overseas.Todd Anderson(Josh Hamilton)spends his days managing a customer call center in Seattle until his job, along with those of the entire office, are outsourced to India.Todd rejects but when his boss informs him that quitting would mean losing his stock options, he has to go to train his Indian replacement Puro(Asif Basra).Out of constant cultural misunderstandings, Todd(Josh Hamilton)is frustrated with everything in India.He eats food by using left hand which is taboo in India.Left hand is considered as dirty hand, which is used for clean something.That’s why T odd(Josh Hamilton)can’t find toilet paper in washroom.It is quite different from America.Also Todd(Josh Hamilton)sees the personal questions, which asked by the hostess, as an embarrassing invasion of his privacy.She questions Todd during his classes, tells him he needs to know more about India.Because of cultural diversity, T odd(Josh Hamilton)has difficulty making the call center employees understand what their American customers expect.In order to get the length of a call down to six minutes, Todd(Josh Hamilton)teaches the Indian employees to speak in American way.While an employee Asha(Ayesha Dharker)questions Todd(Josh Hamilton)during his classes, tells him he needs to know more about India.She becomes his teacher on suchmysteries as Kali, the goddess of destruction(“Sometimes it is good to destroy.Then things can start again.”)Todd(Josh Hamilton)also shows Asha(Ayesha Dharker)the American value and offers her the job of assisting Puro(Asif Basra)when Todd(Josh Hamilton)leaves.“Asha can do anything.” It strengthen Asha(Ayesha Dharker)’s belief to be an independent modern woman.Todd realizes that he too has a lot to learn-not only about India and America, but about himself.He soon discovers that being outsourced may be the best thing that ever happened to him.“Outsourced” is a modern day comedy of cross-cultural conflict and romance.It is a film bursting with affection for its characters and for India.It is about people learning to really see one another.It has a fundamental sweetness and innocence.2第四篇：世界是平的世界是平的：未来营销的五大趋势《销售与市场》，2006-04-30，作者: 俞雷，访问人数: 8183经曾，快速消费品公司创造出了最先进的营销、传播和销售的技术，这些技术大力地推动了中国市场营销的进步。