Contract Manufacturing Arrangements for Drugs: Quality Agreements
Guidance for Industry
行业指南：药品委托生产安排：质量协议
U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
November 2016
Pharmaceutical Quality/Manufacturing Standards (CGMP)
Guidance for Industry
Additional copies are available from:
Office of Communications, Division of Drug Information Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: druginfo@http://biz.doczj.com/doc/21477308.html,
http://biz.doczj.com/doc/21477308.html,/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
and/or
Office of Communication, Outreach and Development C enter for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 71, Room 3128S ilver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-8010
Email: ocod@http://biz.doczj.com/doc/21477308.html,
http://biz.doczj.com/doc/21477308.html,/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
and/or
Policy and Regulations Staff, HFV-6Center for Veterinary Medicine Food and Drug Administration
7519 Standish Place, Rockville, MD 20855
http://biz.doczj.com/doc/21477308.html,/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm
U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
November 2016
Pharmaceutical Quality/Manufacturing Standards (CGMP)
TABLE OF CONTENTS 目录
TABLE OF CONTENTS
目录 (3)
I. INTRODUCTION前言 (4)
II. DEFININGTHEWHO AND WHAT OFCONTRACT MANUFACTURING指定委托生产的人和事 (6)
III. RESPONSIBILITIES OFPARTIES INVOLVED IN CONTRACTMANUFACTURING委托生产所涉及各方的职责7 IV. DOCUMENTINGCGMPACTIVITIES IN QUALITYAGREEMENTS在质量协议中记录CGMP活动 (10)
A.What Is a Quality Agreement? 什么是质量协议？ (10)
B.Elements of a Quality Agreement 质量协议的要素 (11)
V. ILLUSTRATIVE SCENARIOS案例 (17)
A.Owners and Contract Facilities Are Both Responsible for CGMP 所有者和受托场所是否都对CGMP负责？18
B.CGMPs Apply to all Contract Facilities, Including Analytical Testing Laboratories 适用于所有合同场所，包括分析化验室的CGMP (19)
C.Owners and Contract Facilities Perform Change Control Activities 所有者和受托方实施变更控制活动
20
VI. RECOMMENDATIONS建议 (21)
Contract Manufacturing Arrangements for Drugs:Quality
Agreements
Guidance for Industry1
行业指南：药品委托生产安排：质量协议
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on
this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the t itle page.
本指南代表FDA当前对此问题的看法。它并未赋予任何人以任何权力，也不对FDA和公众具有任
何强制约束。如果你有一个替代的方法满足适用的法律法规要求，你可以使用该方法。如需对替代
方法进行讨论，请联系本指南标题页上的FDA官方负责人。
I.INTRODUCTION 前言
This guidance describes FDA’ｓ current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how parties involved in contract drug manufacturing can use quality agreements to delineate their
manufacturing activities to ensure compliance with CGMP.
本指南讲述了FDA当前对于受到CGMP约束的药品委托生产所涉及各方如何定义、设立
和记录生产活动的看法，尤其是药品委托各方如何使用质量协议来描绘其生产活动，以
确保符合CGMP。
For purposes of this guidance, we use certain terms with the following specific meanings:
在本指南中，我们使用了特定的术语，其在指南中的含义如下：
Current Good Manufacturing Practice (CGMP) refers to requirements in the Federal
Food, Drug, and Cosmetic Act (FD&C Act), section 501(a)(2)(B), for all drugs and
active pharmaceutical ingredients (APIs). For finished human and animal drugs, the term
includes applicable requirements under 21 CFR parts 210 and 211. For biologics, the
term includes additional applicable requirements under 21 CFR parts 600-680.
CGMP：指FD&C法案第501（a）(2)(B)中对所有制剂和原料药的要求。对于人用
和兽用制剂，该术语包括21CFR第210和211部分中适用的要求。对于生物制品，
术语还包括21CFR第600-680部分中适用的额外要求。
Commercial manufacturing refers to manufacturing processes that result in a drug or
drugs intended to be marketed, distributed, or sold.
商业化生产：指准备用于上市销售的药品的生产过程。
Commercial manufacturing does not include research and development activities,
manufacturing of material for investigational new drug studies (e.g., clinical trials,
expanded access), or manufacturing of material for veterinary investigational drugs.
1This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the
Center
Center for
for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research, the
Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.
Although this guidance does not explicitly apply to the manufacture of investigational,
developmental, or clinical trial materials, FDA believes that quality agreements can be
extremely valuable in delineating the activities of all parties involved in contract research
and development arrangements. Many of the principles described in this guidance could
be applied in pre-commercial stages of the pharmaceutical life cycle.
商业化生产并不包括研发活动、临床新药研究用原料的生产（例如，临床试验、
扩大使用面），以及兽用临床药所用原料的生产。虽然本指南并未明确指出适用
于临床前、研发、和临床研究用原料，但FDA相信质量协议在描绘委托研发安排
中所有各方活动时会极有价值。本指南中所述的许多原则可以使用于药品生命周
期中商业化之前的阶段。
Manufacturing includes processing, packing, holding, labeling operations, testing, and
quality unit operations.
生产：包括加工、包装、保存、贴标操作、检测和质量部门操作。
A manufacturer is an entity that engages in CGMP activities, including implementation o f
oversight and controls over the manufacture of drugs to ensure quality2.
生产商：指从事CGMP活动，包括实施药品生产监管和控制以确保质量的实体。
Quality unit is defined as synonymous with the term quality control unit3.
质量部门：与质量控制部门是同义词。
This guidance covers commercial manufacturing of the following categories of drugs: human drugs, veterinary drugs, certain combination products, biological and biotechnology products, finished products, APIs, drug substances, in-process materials, and drug constituents of combination drug/device products4.This guidance does not cover the following types of p roducts: Type A medicated articles and medicated feed, medical devices, dietary supplements, or human cells, tissues, or cellular or tissue-based products regulated solely under section 361 of
the Public Health Service Act and 21 CFR part 1271.
本指南覆盖以下类型的药品商业生产：人用药、兽用药、部分药械组合产品、生物制品和
生物技术药品、制剂、原料药、药用物质、在制物料以及药械组合产品中的药物成分。本
指南不覆盖以下类型的产品：A类药用材料和药用饲料、医疗器械、膳食补充剂以及仅受
到公共卫生服务法案第361部分和21CFR第1271部分管理人体细胞、组织和细胞/组织衍
生产品。
In general, FDA’ｓ guidance documents do not establish legally enforceable responsibilities.
current thinking on a topic and should be viewed only as Instead, guidances describe the Agency’ｓ
recommendations, unless specific regulatory or statutory requirements are cited.
The use of the
not word should in Agency guidances means that something is suggested or recommended, but
2See section 501 of the FD&C Act, as amended by the Food and Drug Administration Safety and Innovation Act(Public Law 112-144, title VII, section 711).
参见FD&C法案第501部分及FDA安全和创新法案修正（公共法112-114，标题VII，711部分）
3For quality control unit, see 21 CFR 210.3.
质量控制部门参见21CFR21.3.
4Combination product manufacturers can apply this guidance to their quality agreements because they are subject to requirements under 21 CFR part 211 and/or 21 CFR part 820 (see 21 CFR 4.3).
In addition to facilitating compliance
facilities to
with requirements under 21 CFR part 211, manufacturers can use quality agreements with contract
demonstrate compliance, in part, with 21 CFR 820.50 (purchasing controls) and with 21 CFR 820.80(b)(receiving acceptance activities) for combination products.
药械组合产品生产商可以在其质量协议中适用此指南，因为他们要受到21CFR第211和/或21CFR第820部分（参见21CFR4.3）要求的约束。除了有助于符合21CFR第211部分的要求外，生产商还可以与受托方使用质
量协议来说明其符合组合产品的21CFR820.50（采购控制）和21CFR820.80（b）（接受可接受活动）要求。
required.
一般来说，FDA的指南文件并没有法定强制力。相反，指南描述的只是当局目前对某个议
题的看法，除其中所引用的法律法规要求外，其它内容应该只是作为建议来看待。
SHOULD一词在当局指南中只是表示建议或推荐某事，并不是强制要求。
II.DEFINING THE WHO AND WHAT OF CONTRACT MANUFACTURING 指定委托生产的人和事
This guidance describes how contract manufacturing operations fit within the larger scheme of pharmaceutical quality systems. It also presents the Agency’ｓcurrent thinking on the roles and manufacturing activities of the parties involved in contract manufacturing arrangements.
本指南描述了委托生产操作如何放入药物质量体系的大框架内。它还代表了当局目前对于
委托生产安排中所涉及各方的责任和生产活动。
Specifically, this guidance addresses the relationship between owners and contract facilities. For purposes of this guidance, we define owners as manufacturers of APIs, drug substances, in- process materials, finished drug products, including biological products, and combination products. The term owner does not apply to retail pharmacies, drug stores, supermarkets, discount
counter as warehouse stores, or other retailers who purchase finished drug products to sell over the
contract facilities as parties that perform
a store brand. For purposes of this guidance, we define
one or more manufacturing operations on behalf of an owner or owners5.
具体来说，本指南说明了所有者和委托场所之间的关系。在本指南中，我们将“所有者”定
义为原料药、药用物质、在制物料、制剂成品，包括生物制剂和药械组合产品的生产商。
术语“所有者”并不适用于药品零售、药品存贮、超市、折扣仓库存贮以及其它采购制剂并
销售OTC的零售业者。在本指南中，我们定义“委托场所”为代表一个或多个所有者实施一
个或多个生产操作。
may Drug manufacturing encompasses many discrete operations and activities. One manufacturer perform all operations and activities or may engage an outside party or parties to perform some or all of the operations and activities under contract. Contract facilities perform a variety of manufacturing operations and activities, including but not limited to:
药品生产包括许多不连续的操作和活动。一个生产商可以自己实施所有操作和活动，也可
以通过合同委托一方或多方实施一些或所有的操作和活动。受委托场所实施的不同生产操
作和活动包括但不仅限于：
Formulation
处方
Fill and finish
灌装
Chemical synthesis
化学合成
Cell culture and fermentation, including for biological products
细胞培养和传统发酵，包括生物制品
Analytical testing and other laboratory services
分析检测和其它化验室服务
5A contract facility may also be an owner depending on its role (e.g., when the contract facility is using a subcontractor). 根据其角色的不同（例如，在使用分包商时），合同生产场所也可能会是一个所有者。
Packaging and labeling
包装和标签
Sterilization or terminal sterilization
灭菌和终端灭菌
However, agreements between owners and contract facilities sometimes do not clearly define the CGMP-related roles and manufacturing operations and activities of each of the parties. When all parties clearly understand their CGMP-related roles and manufacturing responsibilities, the owners who use contract facilities, contract facilities that provide services to owners, and, ultimately, patients who take the drugs manufactured under these arrangements may benefit in many ways. Contracting can enhance speed and efficiency, provide technological expertise, and expand capacity.
当然，所有者和受委托场所之间的协议有时并没有清楚界定各方与CGMP相关的义务和生
产操作及活动。如果所有各方均清楚了解其与CGMP相关的义务和生产职责，则使用受托
场所的所有者、向所有者提供服务的受托场所，以及最后，使用在此安排之下所生产的药
品的患者会在各方面受益。委托生产可以提高速度和效率，提供技术专业化，以及扩大产
能。
We encourage entities that engage in manufacturing related solely to drug distribution (e.g., distributors, brokers, private label distributors, own label distributors) to follow the recommendations in this guidance document, as appropriate. Our focus here, however, is on the roles and manufacturing activities of the owner and contract facility.
虽然我们在本指南中主要关注的是所有者和受托生产场所之间的义务和生产活动，但我们
鼓励从事只与药品销售（例如，分销商、代理商、私人标贴分销商、自主标贴分销商）相
关生产的实体在适用情况下采纳本指南文件中的建议。
III.RESPONSIBILITIES OF PARTIES INVOLVED IN CONTRACT MANUFACTURING委托生产所涉及各方的职责
Each party engaged in the manufacture of a drug is responsible for ensuring compliance with CGMP for the manufacturing activities it performs6.For both owners and contract facilities that conduct manufacturing operations, CGMP “includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug 7Drugs not manufactured in compliance with CGMP are adulterated8.
products.”
从事药品生产的各方均有责任确保符合其所实施的生产活动符合CGMP要求。对于所有者
和实施生产操作的受托场所双方而言，CGMP都“包括对药品生产实施监管和控制，以确保
质量，包括对药品和成药生产中所用原料和原材料的风险和安全性的管理”。不符合CGMP 下生产出的药品是掺假药。
The FD&C Act also prohibits any person from introducing or delivering for introduction an adulterated or misbranded drug into interstate commerce9.In addition, it prohibits anyone from
the “doing of any … act with respect to, a … drug … if such act is done while such article is held for sale … after shipment in interstate commerce and results in such article being adulterated or
6Section 501(a)(2)(B) of the FD&C Act; 21 CFR parts 210 and 211; and 21 CFR part 600.
7Section 501 of the FD&C Act as amended by the Food and Drug Administration Safety and Innovation Act (Public Law 112-144, Title VII, section 711).
8Section 501(a)(2)(B) of the FD&C Act.
9Section 301(a) of the FD&C Act.
10
misbranded.”
FD&C法案也禁止任何人将掺假药和冒牌药引入或发送导入州间贸易。此外，还禁止任何
人“在州际贸易运输后存贮待售期间，对药品进行处理使得这些药品成为掺假药或冒牌药”。
FDA’ｓ regulations recognize that owners commonly use contract facilities to perform some drug
quality unit is manufacturing activities11.When an owner uses a contract facility, the owner’ｓ
legally responsible for approving or rejecting drug products manufactured by the contract facility,
responsibilities and
including for final release12.The regulations require that the quality unit’ｓ
procedures be in writing and that they be followed13.
FDA的法规了解所有者通常会使用合同生产场所来实施一些药品生产活动。如果一个所有
者使用了合同生产场所，则所有者的质量部门将承担批准或拒收由该受托场所生产的药品
的法律责任，包括最终放行。法规要求建立并遵守书面的质量部门的职责和程序。
Owners can use a comprehensive quality systems model to help ensure compliance with CGMP.
A comprehensive quality systems model anticipates that many owners will use contract facilities
and calls for quality agreements between owners and contract facilities. Quality agreements
should clearly describe the materials or services to be provided, quality specifications, and communication mechanisms between the owner and contract facility. See guidance for industry
Quality Systems Approach to Pharmaceutical CGMP Regulations14.
所有者可以利用全面的质量体系模型来帮助确保CGMP符合性。全面的质量体系模型预期
到会有许多所有者使用合同工厂，需要在所有者和受托场所之间的质量协议。质量协议应
清楚描述要提供的物料和服务、质量标准，以及所有者和合同场所之间的沟通机制。参见
行业指南《药品CGMP法规下的质量体系方法》。
Owners and contract facilities can review FDA guidance documents for recommendations on
achieving compliance with CGMP. Various FDA guidance documents describe how quality
management principles relate to contract manufacturing operations, including some of the roles
and manufacturing activities of contract manufacturing parties15.
所有者和受托场所可以查阅FDA指南文件，寻求关于达成CGMP符合性方面的建议。有多
份FDA指南文件描述了质量管理原则与委托生产操作之间的相关性，包括合同生产各方的
义务和生产活动。
The following three ICH guidances for industry contain relevant and valuable CGMP
recommendations with respect to contract manufacturing arrangements:
以下三个ICH行业指南中含有很有价值的与委托生产安排相关CGMP建议：
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
Q7 《原料药GMP指南》
Q9 Quality Risk Management
Q9《质量风险管理》
Q10 Pharmaceutical Quality System
10Section 301(k) of the FD&C Act.
1121 CFR 200.10(b) and 211.22(a).
12Ibid.
1321 CFR 211.22(d).
14We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA
Drugs guidance Web page at
http://biz.doczj.com/doc/21477308.html,/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
15See, e.g., guidance for industry Cooperative Manufacturing Arrangements for Licensed Biolog
.
Q10《药物质量体系》
ICH guidance for industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients recommends that owners evaluate contract facilities to ensure that contractor sites comply with CGMP for specific operations16.It also recommends that owners h ave approved written agreements with contractors that define the manufacturing responsibilities in detail, including the quality measures, of each party. The written agreements should also define considerations for subcontracting; describe how changes to processes, equipment,
methods, and
facilities for specifications will be managed; and permit the owner to audit its contractor’ｓ
compliance with CGMP.
ICH行业指南Q7《原料药GMP指南》建议所有者对合同场所进行评估，以确保受托方场
所在指定的操作方面符合CGMP。它还建议所有者与受托方之间有一份书面批准的协议，
在其中详细定义生产职责，包括各方的质量措施。书面协议还应说明对分包的考虑、描述
如何管理工艺、设备、方法和质量标准变更、允许所有者就是否符合CGMP方面审计其受
托方的场所。
ICH guidance for industry Q9 Quality Risk Management offers a systematic approach to quality risk management as part of an effective quality system. It discusses quality risk management
of principles such as risk assessment, risk communication, and risk review and provides examples tools that can be used to make effective and efficient risk-based decisions in, for example, auditing and arranging quality agreements with contract manufacturers.
ICH行业指南Q9《风险管理》提供了质量风险管理的系统方法，它是有效质量体系的一部
分。它讨论了质量风险管理原则，如风险评估、风险沟通和风险审核，并给出了一些工具
的使用实例，这些工具可以用于做出基于风险的有效且高效的决策，如在审计和安排委托
生产质量协议方面。
ICH guidance for industry Q10 Pharmaceutical Quality System states that, as part of a pharmaceutical quality system, the owner is ultimately responsible for ensuring that “processes a re
17It
materials.”
in place to assure the control of outsourced activities and quality of purchased
indicates that these processes should incorporate quality risk management and include the following critical activities:
ICH行业指南Q10《药品质量体系》声明，作为药物质量体系的一部分，所有者对于确保
“有程序确保外包活动的控制和所购物料的质量”有最终责任。它指出这些程序应整合在质
量风险管理中，并包括以下关键活动：
Assessing the suitability and competence of potential contractors before outsourcing
operations or selecting material suppliers. This could be accomplished through audits,
material evaluations, or other qualification criteria.
在将操作外包或选择物料供应商之前，评估潜在合同方的可持续性和资质。可以通
过审计、物料评估或其它确认标准来实现。
Defining the manufacturing responsibilities and communication processes for quality-
related activities of the involved parties. For outsourced activities, these should be in a
written agreement.
界定相关各方质量相关活动的生产职责和沟通流程。对于外包活动，应该在书面协
议上界定。
16In ICH Q7, the term company i s used rather than owner and is used to refer to an API manufacturer.
在ICH Q7中，使用的是“公司”而不是“所有者”来指原料药生产商。
17In ICH Q10, the term c ompany i s used rather than owner.
在ICH Q10中，使用的是“公司”而不是“所有者”。
Monitoring and reviewing the performance of the contract facility and identifying and
implementing any needed improvements.
监测和审核受托场所的表现，识别并实施所需的改进措施。
Monitoring incoming ingredients and materials to ensure they are from approved sources using the agreed-upon supply chain.
监测进厂成分和物料，以确保他们是来自批准过的来源，并且使用的是经过认可的
供应链。
FDA encourages parties engaged in contract manufacturing to implement quality management practices. This guidance is intended to build upon the quality risk management principles and recommendations outlined above and to illustrate key points in developing and executing quality agreements that describe and support contract manufacturing arrangements.
FDA鼓励委托生产各方实施质量管理规范。本指南意在建立上述质量风险管理原则和建议，
解释制订和执行质量协议中的关键点，在协议中描述和支持合同生产安排。
IV.DOCUMENTING CGMP ACTIVITIES IN QUALITY AGREEMENTS 在质量协议中记录CGMP活动
If an owner employs a contract facility for all or part of the manufacturing (including processing,
quality unit is responsible for packing, holding, or testing) of a drug or drug product, the owner’ｓ
product or service18.The contract facility is also approving or rejecting the contract f acility’ｓ
required to comply with statutory CGMP and applicable CGMP regulations, including requirements for its quality unit19.CGMP regulations require that quality unit activities and procedures be in writing, and that these procedures be followed20.
如果一个所有者使用了一个合同工厂来实施药品生产中所有的生产操作（包括加工、包装、
保存和检测），则所有者的质量部门要负责批准和拒收合同工厂的产品或服务。受托场所
也需要符合法定的CGMP和适用的CGMP法规，包括对其质量部门的要求。CGMP法规要求制订并遵守书面的质量部门活动和程序。
Implementing a written quality agreement can facilitate compliance with CGMP and, in p articular, with 21 CFR 211.22(d), which states that quality unit activities and procedures should be in writing. FDA recommends that owners and contract facilities establish a written quality agreement to describe their respective CGMP-related roles, responsibilities, and activities in drug
statutory manufacturing. It is important to note that quality agreements cannot be used to delegate
or regulatory responsibilities to comply with CGMP. The following sections describe the Agency’ｓ
current thinking regarding the documentation of agreed-upon manufacturing activities in a quality agreement, as well as the basic elements of a quality agreement.
实施书面的质量协议可以有助于符合CGMP，尤其是21CFR211.22（d）的要求，在其中说
明了应有书面的质量部门活动和程序。FDA建议所有者和合同场所建立一份书面的质量协
议，以描述双方在药品生产中各自的CGMP相关义务、职责和活动。很重要的一点是要注
意质量协议不能用于委托符合CGMP的法定或法规职责。以下部分描述了当局当前对质量
协议中双方同意的生产活动的文件记录方面以及质量协议基本要素看法。
A.What Is a Quality Agreement? 什么是质量协议？
A quality agreement is a comprehensive written agreement between parties involved in the contract manufacturing of drugs that defines and establishes each
s manufacturing activities
party’
18Section 501(a)(2)(B) of the FD&C Act; 21 CFR 211.22(a).
1921 CFR 210.2(b); 21 CFR 211.22(a).
2021 CFR 211.22(d).
in terms of how each will comply with CGMP. In general, the quality agreement s hould clearly state which party — the owner or the contract facility or both — carries out specific CGMP activities. It should cover activities mentioned in section 501(a)(2)(B) of the FD&C Act and, as applicable, those in 21 CFR parts 210, 211, 600-680, 820, and 1271, as well as all other applicable
party’ｓq uality unit and other statutory or regulatory requirements. Representatives from each
relevant stakeholders should participate actively in the drafting of quality a greements.
质量协议是药品合同生产相关各方之间的全面的书面协议，其中定义和建立了各方在如何
符合CGMP方面的生产活动。一般来说，质量协议应清楚说明哪一方---所有者还是合同工
厂还是双方----要实施指定的CGMP活动。协议应覆盖FD&C法案第501(a)(2)(B)部分，以
及适用时还有21CFR第210、211、600-680、820和1272部分所提及的活动，以及其它所
有适用的法律法规。各方质量部门代表和其它相关的干系人应主动参与质量协议的起草。
confidentiality, Quality agreements should not cover general business terms and conditions such as
pricing or cost issues, delivery terms, or limits on liability or damages. FDA recommends that quality agreements be separate documents, or at least severable, from
commercial contracts such
agreements may be reviewed during as master services agreements or supply agreements. Quality
inspections21.
质量协议不应覆盖通用的商务条款和条件，例如保密、价格和成本问题、运输条款、责任
限制和损坏。FDA建议质量协议与商业合同，例如主服务协议或供应协议，应该分开，或
者至少是可以分开的。在检查期间可能会审核质量协议。
B.Elements of a Quality Agreement质量协议的要素
A quality agreement describes the owner’ｓ
roles and manufacturing
and the contract facility’ｓ
activities under CGMP. A well-written quality agreement will use clear language. It will define key manufacturing roles and responsibilities. It will establish expectations for communication, providing key contacts for both parties. It will specify which products and/or services the owner expects from the contract facility and who has final approval for various activities. Most quality agreements contain the following sections:
质量协议描述了所有者和合同场所的义务和CGMP下生产活动。一份写的很好的质量协议
会使用清楚的语言。它会界定关键的生产义务和职责。它会建立沟通预期、提供双方的关
键联系人。它会指定所有人期望从受托场所那里获得什么产品和/或服务，谁对于不同的活
动有最终批准权。大多质量协议包括以下部分：
Purpose/Scope — to cover the nature of the contract manufacturing services to be provided 目的/范围----在其中包括要提供的委托生产服务的信息
Definitions — to ensure that the owner and contract facility agree on precise meaning of
terms in the quality agreement
定义-----以确保所有者和受托场所对质量协议中术语的含义是准确的
Resolution of disagreements — to explain how the parties will resolve disagreements
about product quality issues or other problems
争议时的解决方案----解释各方要如何解决关于产品质量方面的分歧和其它问题
Manufacturing activities — to document quality unit and other activities associated with
manufacturing processes as well as control of changes to manufacturing processes
生产活动----记录质量部门和其它与生产工艺和生产工艺变更控制相关的活动
21See section 704 of the FD&C Act.
Life cycle of, and revisions to, the quality agreement
质量协议的生命周期及其修订
established processes and procedures as The owner may consider including the contract facility’ｓ
part of the quality agreement (for example, by incorporating certain standard operating procedures by reference). Doing so could reduce the risk of misinterpretation or error during m anufacturing. The quality agreement should explain how the contractor will report m anufacturing deviations to the owner, as well as how deviations will be investigated, d ocumented, and resolved in compliance with CGMP. Quality agreements should state that manufacturing services provided by contract facilities (including laboratories) will comply with CGMP.
所有者可以考虑将受托场所已建立的流程和程序作为质量协议的一部分（例如，通过将某
些标准操作程序以引用方式加入）。这样做会减少生产中误解或犯错的风险。质量协议应
解释受托方要如何向所有者报告生产偏差，以及如何按CGMP要求调查、记录和解决偏差。质量协议应声明由受托场所提供的生产服务（包括化验室）将符合CGMP。
From a CGMP perspective, manufacturing activities are the most important element in a quality agreement. The most critical pieces are quality and change control, as described in the following sections.
从CGMP的角度来说，生产活动是质量协议中最重要的要素。最关键的部分是下面部分所
述的质量和变更控制。
1.Manufacturing Activities 生产活动
roles and manufacturing activities with a variety Quality agreements may document each party’ｓ
of formats — charts, matrices, narratives, or a combination of these. Regardless of the format, a quality agreement should clearly document which party is responsible for specific activities. No party to a quality agreement may delegate any of its responsibilities to comply with CGMP through the quality agreement or any other means. The quality agreement should cover all of the activities for ensuring compliance with CGMP. Depending on the scope of the contract manufacturing services to be provided, the quality agreement should indicate whether the owner or contract facility (or both) will handle specific activities related to each of the following topics:
质量协议可以以不同格式记录各方的义务和生产活动---图表、矩阵、叙述或这几种方式的
联合。不管格式如何，一份质量协议应清楚记录何方负责特定的活动。任何一方均不可通
过质量协议或其它任何方式将其符合CGMP的职责委托给他方。质量协议应覆盖确保
CGMP符合性的所有活动。根据要提供的委托生产服务的不同，质量协议应指明是所有者
还是受托方（或双方）要处理与以下主题相关的特定活动：
a.Quality unit activities 质量部门活动
quality unit activities should define The section of a quality agreement that addresses each
party’ｓ
in detail how the parties will work together to ensure that products are manufactured in compliance with CGMP. Note that assigning quality control or other activities to either the o wner or contract facility in the quality agreement does not relieve either party from compliance with applicable CGMP requirements.
质量协议中说明各方质量部门活动的部分应详细界定各方将如何共同努力以确保产品在符
合CGMP的情况下生产。注意，在质量协议中指派所有者或受托方完成质量控制或其它活
动并不免除另一方符合适用CGMP要求的职责。
In particular, this section of the quality agreement should be clear with respect to product release. Contract facilities are responsible for approving or rejecting the product or results of their
22.In manufacturing operations (e.g., test results, finished dosage forms, or in-process materials) addition, owners are responsible for approving or rejecting drugs manufactured by the contract facility23,including for final release. In all cases, the owner must not introduce or deliver into interstate commerce, or cause to be introduced or delivered into interstate commerce, any drugs that are adulterated or misbranded24.
尤其是，质量协议的这一部分应清楚说明产品放行的内容。受托方有责任批准或拒收其生
产操作的产品和结果（例如，检验结果、制剂或在制品）。另外，所有者负责批准和拒收
由受托方生产的药品，包括最终放行。在所有情形下，所有者不得向州际贸易引入或发运，
或导致引入或发运任何掺假药和冒牌药。
Within its quality unit activities, a quality agreement should describe how and when the owner and contract facility will communicate with each other, both verbally and in writing. This includes
organization. identifying appropriate contact personnel within the owner’ｓ
and contract f acility’ｓ
在其质量部门活动中，质量协议应描述所有者和受托方要在何时如何与对方联系，包括口
头和书面。这包括明确所有者和受托方公司里适当的联系人。
Quality agreements should also cover audits, inspections, and communication of findings. The agreement should allow owners to evaluate and audit contract facilities to ensure CGMP compliance for specific operations. This provision should cover both routine quality audits and
regarding for-cause audits. The agreement should also set owner and contract facility expectations
FDA inspections (pre-approval, routine surveillance, and for-cause) with consideration for the nature of the products to be manufactured and/or services to be provided. It should
include the agreed-upon provisions for communicating inspection observations and findings, as well parties’
as relevant FDA actions and correspondence.
质量协议还应覆盖审计、检查和沟通。协议应允许所有者评估和审计受托方，以确保特定
操作的CGMP符合性。此条款应覆盖日常质量审计和有因审计。协议还应设定所有者和受
托方关于FDA检查的预期（批准前检查、日常监管和有因检查），在其中考虑将要提供的
生产和/或服务产品的特性。其中应包括各方同意的检查缺陷、相关FDA措施和通信沟通
条款。
Because contract facilities often provide services to multiple owners, the quality agreement should address when, how, and what information the contractor will report to owners about o bjectionable conditions observed during inspections and audits of the contract facility.
由于合同方通过会为多个所有者提供服务，质量协议应说明受托方何时以何种方法将官方
检查中和合同工厂审计中发现的负面情况中的何种信息报告给所有者。
b.Facilities and equipment 设施和设备
This section of a quality agreement should identify the specific site(s) where the contract facility will perform manufacturing operations, including the address of and specific services to be provided at each site. It should indicate which party will be validating processes and qualifying and maintaining equipment and applicable systems relevant to the contracted operations. These include information technology and automated control systems, environmental monitoring and room classification, utilities, and any other equipment and facilities that must be maintained to perform the contracted manufacturing operations in compliance with CGMP. The agreement also should identify which party will approve equipment validation, qualification, and maintenance activities. In addition, it should indicate how the parties will communicate information about preventing cross-contamination and maintaining traceability when a contract facility processes
2221 CFR 211.22(a).
23Section 501(a)(2)(B) of the FD&C Act; 21 CFR 211.22(a).
24See section 301(a) of the FD&C Act.
drugs for multiple owners.
质量协议的本部分应识别出受托方要实施生产操作的指定地点，包括地址和每个地点所提
供的具体服务。其中应指出何方将验证工艺，确认和维护与委托操作相关的设备和适用系
统。其中包括信息技术和自动化控制系统、环境监测和空间分级、公用系统和其它所有必
须维护以在CGMP条件下实施合同生产操作的设备和设施。安排还要识别何方应批准设备
验证、确认和维护活动。另外，如果受托方为多个所有者生产药品时，协议应指出各方要
如何沟通关于防止交叉污染和维护可追溯性的信息。
c.Materials management 物料管理
This section of a quality agreement should indicate which party will establish specifications for components as well as which party will establish processes for auditing, qualifying, and monitoring component suppliers. It should also identify which party will conduct required sampling and testing in compliance with CGMP. This section of the quality agreement should address how the parties will ensure appropriate inventory management, including labeling, label printing, inventory reconciliation, and product status identification (e.g., quarantine). The agreement should address how the contract facility will prevent mix-ups and cross- contamination. FDA does not expect the agreement to contain a complete description of the supply chain for each component. However, the agreement should define responsibility for physical control of materials at different points in the manufacturing process. F or example, the quality agreement should cover responsibilities for proper conditions for storing and transporting or shipping materials. It should roles in storage and transport — whether from the contract facility back to the define each p arty’s
owner or to another contract facility for further operations. This includes defining activities for monitoring or validating shipping conditions as appropriate.
质量协议的本部分应指明哪方要建立成分的质量标准，以及哪方要建立审计、确认和监测
成分供应商的流程。其中还要识别出哪方要按CGMP要求实施所需的取样的检测。质量协
议的本部分应说明各方要如何确保适当的在库管理，包括贴标、标签打印、库存数据平衡
以及产品状态识别（例如待验）。协议应说明受托方要如何防止混药和交叉污染。FDA并
不要求在协议中包括每个成分的供应链完整描述。但是，协议中应界定生产过程不同阶段
物料的实物控制职责。例如，质量协议应覆盖物料存贮、运输和发运的适当条件的职责。
其中应界定各方在存贮和运输中的职责----是从合同生产场所送回至所有者，还是发给另一
个合同生产场所用于进一步操作。其中包括适当时监测和验证运输条件的活动。
d.Product-specific considerations 与产品相关的考虑
A comprehensive quality agreement may address specific considerations related to individual products. The owner and contract facility might opt to include this information in an appendix, o r directly in the body of the quality agreement. In either case, if included, this section of the quality
expectations of each other regarding:
agreement should include the parties’
一份全面的质量协议可以说明与单个产品相关的特定考虑。所有者和受托方可以选择将此
信息放在附录中，或直接放在质量协议的正文中。不管放在哪里，如果质量协议中包括了
这些内容，则该部分应包括各方对另一方在以下方面的要求：
Product/component specifications
产品/组分质量标准
Defined manufacturing operations, including batch numbering processes
定义的生产操作，包括批编号流程
Responsibilities for expiration/retest dating, storage and shipment, and lot disposition
有效期/复验期、存贮和运输以及批处理责任
Responsibilities for process validation, including design, qualification, and ongoing
verification and monitoring
工艺验证，包括设计、确认、和持续确认和监测方面职责
Provisions to allow owner personnel access to the contract facility when appropriate
允许所有者人员在适当时进入受托方场所的条款
The quality agreement also should indicate how owners will transfer knowledge, such as product and process development information, to contract facilities to ensure a drug can be manufactured in compliance with CGMP, and conversely how contract facilities should share with owners product quality information gained throughout the product life cycle. This applies to knowledge about all drugs, including drugs subject to an approved application (e.g., new drug application) and nonprescription drug products marketed under an over-the-counter drug monograph.
质量协议也应说明所有者要如何转移知识，如产品和工艺研发信息，给受托方，以确保药
品生产符合CGMP，并反向获取受托方如何与所有者分享在产品生命周期中获得的产品质
量信息。这适用于所有药品的知识，包括需要批准的申报的药品（例如，新药申报）和根
据OTC药品各论上市销售的非处方药品。
Owners that hold an approved drug application should be aware of application and approval requirements that could affect manufacturing activities. Both parties to a quality agreement should share relevant information to ensure compliance with CGMP and other applicable requirements of the FD&C Act.
持有已批准药品申报的所有者应了解可能会影响生产活动的申报和批准要求。质量协议的
双方均应分享相关信息，以确保符合CGMP和其它适用的FD&C法案要求。
http://biz.doczj.com/doc/21477308.html,boratory controls 实验室控制
The owner and contract facility should both have access to adequate laboratory facilities for testing of their drugs. A quality agreement will help each party meet this need by defining roles and responsibilities for laboratory controls. We recommend the following elements:
所有者和受托方双方均应具备足够的化验室设施用于检测其药品。质量协议将有助于双方
通过界定双方在化验室控制方面的义务和职责来满足其需求。我们建议包括以下要素：Procedures delineating controls over sampling and testing samples
取样和样品检测控制程序
Protocols and procedures for communicating all laboratory test results conducted by
contract facilities to the owner for evaluation and consideration in final product d isposition decisions
与所有者沟通由受托方实施的所有化验室检验结果的方案和程序，以及在最终产品
处理决策中的考虑
Procedures to verify that both owner and contract facilities accurately transfer development, qualification, and validation methods when an owner uses a contract facility for laboratory testing
当所有者使用合同化验室用于分析时，确认所有者和受托方双方均准确转移开发、
确认和验证方法的程序
Routine auditing procedures to ensure that a contract
laboratory equipment is
facility’ｓ
qualified, calibrated, and maintained in a controlled state in accordance with CGMP
日常审计程序，以确保合同化验室设备根据CGMP要求确认、校正的维护在受控状
态
Designation of responsibility for investigating deviations, discrepancies, failures, out-of-
specification results25,and out-of-trend results in the laboratory, and for sharing reports of
such investigations
指定调查化验室里的偏差、不一致、失败、OOS结果、OOT结果，以及分享此类调
查报告的职责
f.Documentation 文件记录
The quality agreement should define expectations between the contract facility and the owner to review and approve documents. It also should describe how changes may be made to standard operating procedures, manufacturing records, specifications, laboratory records, validation documentation, investigation records, annual reports, and other documents related to products or services provided by the contract facility. The quality agreement should also define owners’ and in making and maintaining original documents or true copies in
contract facilities’ roles
accordance with CGMP. It should explain how those records will be made readily available for inspection.
质量协议应界定受托方和所有者之间关于审核和批准文件的要求。其中还应描述要如何对
由受托方提供的标准操作程序、生产记录、质量标准、化验室记录、验证文件、调查记录、
年度报告和其它与产品或服务有关的文件进行变更的程序。质量协议还应定义所有者和受
托方在根据GMP制作和维护原始文件和真实副本的义务。其中应解释要如何使这些记录在
检查期间易于获得。
The quality agreement also should indicate that electronic records will be stored in accordance with CGMP and will be immediately retrievable during the required record-keeping time frames established in applicable regulations.
质量协议还应指明要根据CGMP存贮电子记录，在适用的法规所要求的记录保存时间段内
能立即恢复这些记录。
2.Change Control Associated With Manufacturing Activities 生产活动相关的变更控制
Either an owner or a contract facility may initiate changes to processes, equipment, test methods, specifications, and other contractual requirements. Both parties should discuss changes and address them in the quality agreement. There are some changes that owners should review and approve before they are implemented and other changes contractors may implement without
including notifying the owner. How all changes are managed should be outlined in the agreement, allocation of responsibilities for conducting validation activities as needed before i mplementing
be submitted to changes. Additionally, both parties should be aware of those changes that need to
FDA in a supplement or annual report. The owner and contract facility should carefully consider
need for approval
and agree on the types of changes to report to each other and to FDA and the
quality unit and FDA, as applicable. The quality agreement s hould address
from each party’ｓ
expectations for reporting and approving changes to the following:
所有者和受托方均可以启动对工艺、设备、检验方法、质量标准和其它合同约定要求的变
更。双方应对变更进行讨论，在质量协议中对其进行说明。有一些变更需要由所有者在实
施之前进行审核和批准，而另一些变更则不需要通知所有者，受托方可以直接实施。在协
议中应列出所有变更要如何管理，包括在执行变更之前实施所需验证活动的职责分配。另
外，双方还应了解需要在增补和年报中呈交给FDA的变更。所有者和受托方应仔细考虑，
25Refer to the guidance for industry Investigating Out-of Specification (OOS) Test Results for Pharmaceutical Production.
参见行业指南《药品生产中OOS结果的调查》。
在向对方和FDA报告的变更类型，以及需要获得对方质量部门和必要时获得FDA批准上
达成一致。质量协议应说明报告和批准以下变更的要求：
Components and/or their suppliers
成分和/或其供应商
Establishment locations
工厂位置
Manufacturing processes
生产工艺
Products or product types that use the same production line, equipment train, or facility
使用相同生产线、设备链或工厂的产品或产品类型
Testing procedures
检验方法
Major manufacturing equipment
主要生产设备
Shipping methods
运输方式
Lot numbering scheme
批号给定方式
Container closure systems
容器密闭系统
Tamper evidence features
防伪证据特点
Product distribution
产品运输销售
adverse Various unexpected events, such as manufacturing deviations, complaints, product recalls,
event reports, master label changes, field alert reports, and biological product deviation reports, may necessitate changes to processes and procedures. Process improvement projects,
process
procedures. capability analyses, and trending reports may also necessitate changes to processes and
expectations for reporting
and contract f acility’ｓ
The quality agreement should include the owner’ｓ
and communication in case of unexpected events and related changes.
许多意外的事件，如生产偏差、投诉、产品召回、不良事件报告、主标签变更、现场警示
报告和生物制品偏差报告，可能会需要对工艺和程序进行变更。工艺改进项目、工艺能力
分析和趋势分析报告也可能会需要对工艺和程序进行变更。质量协议应包括当意外事件和
相关变更发生时，所有者和受托方对报告和沟通方面的要求。
V.ILLUSTRATIVE SCENARIOS 案例
The following hypothetical scenarios illustrate common problems in contract manufacturing arrangements and depict ways in which both owners and contract facilities can affect product
current thinking regarding potential ways to quality. These scenarios also demonstrate FDA’ｓ
resolve problems. The examples provided are not intended to encompass all drug manufacturing
Rather, they provide problems related to arrangements between owners and contract facilities.
industry and other stakeholders with patterns FDA investigators frequently encounter and analyses of the facts within these patterns.
以下设想情形展示了委托生产安排中的常见问题，描绘了所有者和受托方双方都可能影响
产品质量的方式。这些情形也证明了FDA当前对解决问题可能方法的思考。所给出的案例
无意列出与所有者和受托方之间安排相关的所有药品生产问题，而只是为行业和其它干系
人提供一些FDA调查人员常常遇到的模式，并对这些模式里的事实进行分析。
A.Owners and Contract Facilities Are Both Responsible for CGMP 所有者和受
托场所是否都对CGMP负责？
Case 1: Facilities and Equipment Maintenance and Upkeep at Contract Facility
案例1：合同工厂里设施和设备维护和保养
An FDA inspection of a contract facility that manufactures an injectable drug p roduct for
an owner reveals significant objectionable conditions at the contract facility. Most of the
objectionable conditions relate to deficient maintenance of facilities and equipment used to manufacture the injectable drug product.
一次对受托生产注射剂的合同生产场所的FDA检查中发现合同生产场所有重大违规
情形。大部分违规情形与用于注射剂生产的设施和设备的维护缺陷有关。
facility Equipment is broken. Pipes are tarnished, and seals are leaking. In addition, the
design does not adequately prevent contamination. A quality agreement between the
contract facility and the owner states that the owner is responsible for upgrades and
product. The maintenance of the facilities and equipment used to manufacture the owner’ｓ
owner has failed to provide upgrades and perform maintenance, and the contract facility
continues to manufacture the product under non-CGMP conditions with risk of
contamination.
设备破损、管道灰暗、密封泄漏。此外，设施设计不能充分防止污染。受托方和所
有者之间的质量协议声明所有者负责对所有者产品生产所用设施和设备的升级和维
护。所有者未能提供升级以及实施维护，受托方继续在有污染风险的非GCMP条件
下生产药品。
Case 2: Documenting Steps in the Manufacturing Process
案例2：生产规范中的文件记录步骤
A contract facility is manufacturing a prescription drug product for an owner. F DA has
approved an application from the owner for this drug. On inspection, FDA observes that
batch records do not accurately reflect t he actual manufacturing the contract f acility’ｓ
addition of reclaimed powder.
process because the batch records do not document the
Despite the fact that the batch records are inaccurate and are therefore not compliant with CGMP, the contract facility claims that its batch records comply with expectations set out in the quality agreement with the owner.
一个合同生产场所正在为一个所有者生产一个处方药。FDA已经批准了所有者对此
药的申报。在检查中，FDA发现合同生产场所的批记录没有准确反映实际生产工艺，
因为批记录并未记录加入回收粉的情况。虽然批记录是不准确的，因此不符合
CGMP，但合同生产方声称其批记录符合与所有者签订的质量协议中设定的要求。
In the cases described above, the owners and contract facilities appear to be in violation of
CGMP.
A quality agreement cannot exempt owners or contract facilities from statutory or regulatory
responsibilities to comply with applicable CGMP, regardless of whether the quality a greement specifically discusses those CGMP requirements. In case 1, the contract facility violates CGMP requirements by continuing to manufacture on outdated or poorly designed equipment, even
and upkeep of the though the quality agreement says that the owner is responsible for maintenance
equipment. In case 2, the contract facility violates CGMP by using a batch record that does not
consistent with what accurately reflect the manufacturing process, even though the batch record is
was set out in the quality agreement.
在上述案例中，所有者和合同生产工厂违背了CGMP。尽管质量协议中特别讨论了这些CGMP要求，但一份质量协议并不能使得所有者和合同生产工厂豁免于符合适用CGMP的法律法规责任。在案例1中，即使质量协议说所有者负责维护和保养设备，但合同生产工
厂持续在落后的设计不良的设备上生产，违背了CGMP要求。在案例2中，虽然批记录符
合质量协议中所设定的要求，但合同生产工厂使用了不能准确反映生产过程的批记录，违
背了CGMP要求。
compliance At the same time, the owner remains responsible for ensuring its products are made in
with CGMP even when a quality agreement assigns a particular manufacturing activity to the contract facility. After finding problems at a contract facility, such as the ones d escribed in the cases above, FDA might determine that it is appropriate to inspect the owner. The owner could
manufacturing also be in violation of CGMP related to its failure to oversee the contract f acility’ｓactivities.
同时，即使质量协议中将某个生产活动指派给了合同生产工厂，但所有者仍负有确保其产
品生产符合CGMP的责任。在发现合同生产工厂的问题后，例如上述案例中的问题，FDA 可能会决定有必要对所有者进行检查。所有者也可能由于未能监管合同生产工厂的生产活
动而被认为违背CGMP。
B.CGMPs Apply to all Contract Facilities, Including Analytical Testing
Laboratories 适用于所有合同场所，包括分析化验室的CGMP
Case 3: Unreliable Data in Laboratory Records and Test Results
案例3：化验室记录和检测结果中不可靠的数据
In this scenario, an owner contracts with a facility for analytical testing services. The
contract facility repeatedly reports passing results in its CGMP records when actual
analyses indicated failures. T he contract facility also fails to report accurate results to the owner, who is the finished drug product manufacturer.
在此案例中，一个所有者与一个提供分析检测服务的场所签订委托合同。受托化验
室反复在其CGMP报告合格结果，但实际的分析结果其实是不合格的。合同化验室
也没有向所有者报告准确的结果，而所有者才是制剂产品的生产者。
When FDA inspects the owner, it finds that despite having a written procedure requiring a site audit of contract facilities every 2 years, the owner has not audited the analytical
testing facility.
在FDA检查所有者时，FDA发现尽管有书面程序要求对合同化验室每2年进行一次
现场审计，但所有者从来没有审计过合同化验室。
Case 4: Contracted Analytical Testing Laboratory and Method Validation
案例4：合同分析化验室和方法验证
An owner contracts with a facility to perform stability testing and other analyses o f its
newly approved drug. FDA approval and a quality agreement with the owner require the
new
described in the o wner’ｓdrug to be manufactured using these processes, which are
drug application (NDA). The contract facility uses an analytical method contained in the
duplicate sample NDA but gets several out-of-specification results. Also, the facility’ｓ
analyses occasionally point to possible unacceptable variations in drug concentration. The facility investigates the varying results and concludes that the failures are related to the
sample preparation techniques but does not clearly identify the problem. Despite this, the
contract facility continues to use the noncompliant method to test the product.
一个所有者与一个场所签订合同对其新批准的药品进行稳定性测试和其它分析。
FDA的批准和与所有者之间的质量协议要求受托方使用在所有者NDA中所述的方法
进行检测。受托化验室使用了NDA中的分析方法，但得到了几个OOS结果。还有，受托化验室重复样品检测偶然发现药品浓度可能有不可接受的波动。该化验室调查
了有差异的结果，得出结论是该检测失败与样品制备技术有关，但没有清楚识别出
问题。尽管如此，受托化验室仍继续使用不合规的方法来检测产品。
When FDA inspects the contract facility, it finds that the facility failed to fully investigate
the problems and implement corrective actions. The contract facility c laims that because it
analytical method as specified in the p roduct application, it is not used the o wner’ｓ
responsible for investigating and implementing corrections related to it.
当FDA检查合同化验室时，FDA发现化验室没有全面调查问题并实施纠正措施。合
同化验室声称因为它使用了所有者在产品申报资料中指定的分析方法，因此不负责
调查、实施与其有关的纠正措施。
In both of the cases above, FDA might conclude that the contract facilities are responsible for violating CGMP applicable to the laboratory activities they perform. FDA could also conclude that the owners are responsible for CGMP violations. Analytical testing laboratories are responsible
for operating in compliance with CGMP regardless of quality agreements they may have with
reliable and owners. They must employ adequate controls to ensure that data and test results are
responsibility to review this maintained in accordance with CGMP requirements. It is the owner’ｓ
information from the contract facility to decide whether to approve or reject product for release and distribution26.
在上述2个案例中，FDA都可能得出结论说受托方要为其所实施的化验室活动违背CGMP
承担责任，也可以得出结论说所有者要为CGMP违规承担责任。不论其是否与所有者签订
有质量协议，分析化验室都对其按CGMP运行负有责任。他们必须采取适当的控制来确保
数据和检测结果是可靠的，并根据CGMP要求进行维护。而所有者则有义务审核来自受托
方的此信息，决定是批准还是拒绝将产品放行销售。
quality units are ultimately responsible for ensuring No matter who tests the products, the owners’
that the products are manufactured in accordance with CGMP. A quality agreement does not change that. FDA could cite the owners in cases 3 and 4 further for failing to evaluate, qualify, audit, and monitor their contract facilities.
C.Owners and Contract Facilities Perform Change Control Activities 所有者和受
托方实施变更控制活动
Case 5: Approving or Rejecting Changes That Affect Product Quality and CGMP
Compliance
案例5：批准或拒绝影响产品质量和CGMP符合性的变更
A contract facility informed the owner about obvious powder segregation issues. The
contract facility had attempted to correct the problem by making changes to the equipment, but then determined that the issues could not be fixed without process redesign and
26See, for example, §
§ 211.22(a), 211.68, 211.180, 211.188, and 211.194(a).
编号：_______________本资料为word版本，可以直接编辑和打印，感谢您的下载 委托代理进口协议书(BILL) 甲方：___________________ 乙方：___________________ 日期：___________________ 说明：本合同资料适用于约定双方经过谈判、协商而共同承认、共同遵守的责任与 义务，同时阐述确定的时间内达成约定的承诺结果。文档可直接下载或修改，使用 时请详细阅读内容。
协议书编号： 签定日期： 签定地点：上海 甲方（受托方）： 乙方（委托方）： 经双方友好协商，根据〈〈合同法》外经贸部〈〈关于对外贸易代理制的暂行规定》和外经贸部、海关总 署、国家外汇管理局发的〈〈规范进出口代理业务的若干规定》，就乙方委托甲方在上海口岸代理进口的有关 事项达成如下协议： 一、乙方委托甲方代理进口，具体内容如下： 1.1品名：等产品 1.2有关产品的名称、规格、牌号、型号、产地、制造商、数量、单价等以实际进口合同为准。 二、甲方接受乙方委托，同意以甲方的名义代理以下工作； （1）进口代理；（2）进口检验检疫申报、报关或委托报关；（3）购付汇 三、报关、运输委托方式： 3.1甲方同意委托由乙方指定的服务方办理保管运输等手续，费用由乙方自行与服务方结算。 3.2国内或国外运输如须办理保险，乙方应提前七个工作日书面通知甲方。 四、进口来源国及客户由乙方指定。 五、费用及结算： 5.1代理费结算 5.1.1结算标准：乙方需支付甲方进口代理费，代理费收取标准为： 1）普通货物：甲方不垫付货款以每单进口发票完税金额的0.8%,其中每单进口代理费的最低收费标准为 1000元人民币。 2）食品：甲方不垫付货款以每单进口发票完税金额的 2.5%，其中每单进口代理费的最低收费标准为2000元人民币。如货物按集装箱进，收费标注为3000元。 3）许可证货物：甲方不垫付货款以每单进口发票完税金额的 1.5%,其中每单进口代理费的最低收费标准 为1500元人民币。 4）特别许可证货物：重新面议单票收费标注。 5.1.2结算方式：甲方于次月初向乙方提供上月代理费结算清单，乙方应在收到后三个工作日内予以核算, 经乙方核
编号：QJ-HT-0096委托代理进口协议(新编版) Both parties to the contract shall perform their obligations in accordance with the contract or the law within the contract period. 甲方：_____________________ 乙方：_____________________ 日期：_____________________ --- 专业协议范本系列下载即可用---
委托代理进口协议(新编版) 说明：该协议书适用于甲乙双方为明确各自的权利和义务，经友好协商双方同意签署协议，在协议期限内按照协议约定或者依照法律规定履行义务，可下载收藏或打印使用（使用时请先阅读条款是否适用）。 协议号：_________ 委托人：_________（以下简称甲方） 法定代表人：_________ 地址：_________ 邮编：_________ 电话：_________ 传真：_________ 代理人：_________（以下简称乙方） 法定代表人：_________ 地址：_________ 邮编：_________ 电话：_________
传真：_________ 甲、乙双方经友好协商，就_________进口项目事宜，根据国家现行的法律、法规和政策之规定，于_________年_________月_________日在_________签订协议条款如下，以资信守。 一、甲方委托乙方作为其进口项目的代理人，乙方接受甲方委托，代理甲方对外签订和执行该项目进口合同。 二、甲方委托乙方代理进口_________项目。详细情况如下： 卖方：_________ 地址：_________ 电话：_________ 传真：_________ 商品名称及规格：_________ 单价：_________ 数量：_________ 总价：_________ 价格条款：_________
委托代理记账协议书 Accounting Agent Engagement Agreement Date: 编号： 甲方： Party A: 乙方： Party B: . 委托事由 Recitals 1. 甲方希望委托乙方代理甲方的会计和税务工作； Party A wishes to entrust Party B as its accounting and tax agent. 2．乙方接受甲方的委托，根据《企业会计准则》、《中华人民共和国外商投资企业会计制度》、《中华人民共和国会计法》及财政、税务等有关法律、法规的规定，为甲方公司提供代理记账、财税咨询和税务申报代理服务。 Party B agrees to act as Party A’s accounting and tax agent to provide bookkeeping, finance consulting and tax agency services to Party A in according with the terms and conditions set out in this Accounting Agent Engagement Agreement (herein after referred to as “Agreement”) under Accounting Law of P.R. China and relevant rules and regulations. 1. 权限申明 Authority and Jurisdiction 1.1甲方委托授权乙方完成下述协议条款2中所规定内容（以下称“委托项目”），具体服务内容见合同附件一。 Party A entrusts and authorizes Party B to act as its agent to accomplish the items set out in Article 2 below (hereinafter referred to as “entrusted items”). Detailed service item describes in contract appendix I. 1.2以上条款规定的委托和授权任何时候都不被视为是本协议双方的合伙关系； The entrustment and authorization as stated in Article 1.1 above should not at any time be regarded as the partnership relationship between the parties of this Agreement. 1.3本协议的条款、作用和解释，因本协议引发争议的解决和本协议的执行受中国人民共和国法律约束。 Any articles, effect and interpretation of this Agreement and the settlement of disputes arising from this Agr eement or its performance shall be governed by the law of the People’s Republic of China. 2．责任范围和委托项目 Responsibilities and Commitments 2.1甲方责任范围 Party A 1)建立健全内部控制，保证资产的完整性； To constitute integrated internal control system and ensure the integrality of account of company assets. 2)做账材料交接： Accounting documents handover: a)向乙方提供合法、真实、准确、完整的原始凭证和原始凭证相关单据，进行分类编号后交给乙方； To provide legal, true, exact and whole original vouchers and related supporting documents to Party B which have been sorted and numbered. b)负责原始凭证审核； To responsible for audit of its original vouchers. c)对于乙方退回不符合会计制度规定要求的凭证应当及时予以更正，补充； To correct, replenish the accounting documents required when Part B return the unqualified voucher and related supporting documents timely. d)妥善保管所有原始凭证、财务报表及经税务机关审核后的纳税申报表等资料。 To preserve all the original vouchers, finance statements and taxation sheets. e)甲方定期与乙方提供的帐面数额核对;每月必须在当月月底和乙方确定报税事宜。（包括确认：甲 方向乙方告知的开票金额，抵扣金额等事宜） To cross check the account balance provided by Part B, and confirm the monthly tax filing issues. ( Including invoiced amount and deductions etc. )
商品质量保证协议书范本 甲方：_______________（以下简称甲方） 乙方：_______________（以下简称乙方） 为确保乙方所有商场在销售的商品质量，保护消费者的合法权益，提高甲、乙双方企业管理水平，根据国家商品质量法规和市流通领域商品准入工程操作规程，经甲、乙双方协商，特签订如下协议： 一、甲方供给乙方的所有商品必须符合国家及地方的法律、法规，如甲方出现《浙江省查处生产、经销假冒伪劣商品行为条例》第六条情况（详见附表一）之一时，乙方将立即停止甲方所有商品在乙方的销售、冻结甲方在乙方的所有货款，在甲方承担乙方所有损失（包括乙方信誉损失赔偿金_______-_____万元）后对甲方的所有商品作永久的清场处理，情节严重触犯刑法的，乙方将移交司法部门依法追究刑事责任。 二、甲方供给乙方的商品必须经过乙方商品行政部质量认证，经认证通过后方可进行业务洽谈，甲方同意乙方的未付货款中有_____元可作为质量保证金，在发生质量事件时可以扣除。如甲方采取套用条码等弄虚作假的手段，未经乙方认证通过擅自进场销售，无论商品质量合格与否，乙方将立即清场该商品，甲方同意赔偿给乙方工作带来影响造成损失
_____-_____元，擅自进场销售商品符合本协议第一条情况时，按第一条处理。 三、乙方根据国家有关部门规定向甲方索取与商品质量有关的证件，甲方应主动出具有效证件，其中食品应由生产企业出具每批次产品质量检验合格证件或企业内部检测报告（按有关部门要求对部分敏感食品要求出具每批次产品质量检验报告，下同）。如甲方出具的证件系伪造或虚假的，乙方按上述第二条规定处理；甲方出具的证件到期前要及时更换新的有效证件，如甲方证件到期，经乙方书面催促一次仍未按书面催促书约定时间将有效证件送达乙方，乙方有权暂停支付甲方货款，直至甲方送达；甲方未及时出具食品每批次产品质量检验合格证或企业内部检测报告，乙方有权代为送检，代为送检和检测的费用由甲方承担。其中，乙方代为送检的费用为检测费用的X-X倍。 四、因甲方无意过失造成商品质量问题（详见附表二）时，甲方同意立即改进过失，承担乙方对顾客处理的经济损失并赔偿给乙方工作带来影响造成损失_____-_____元。 五、甲方主观故意造成商品质量问题（详见附表三）时，甲方同意该商品清场，承担乙方对顾客处理的经济损失并赔偿给乙方工作带来影响造成损失_____-_____元。 六、甲方同意按本协议应付乙方的赔偿金、费用以及一切损失支出，无需甲方确认，乙方可在甲方的商品质量保证
YOUR LOGO 委托进口代理合同范本正式版 After The Contract Is Signed, There Will Be Legal Reliance And Binding On All Parties. And During The Period Of Cooperation, There Are Laws To Follow And Evidence To Find 专业合同范本系列，下载即可用
委托进口代理合同范本正式版 使用说明：当事人在信任或者不信任的状态下,使用合同文本签订完毕，就有了法律依靠,对当事人多方皆有约束力。且在履行合作期间,有法可依,有据可寻，材料内容可根据实际情况作相应修改，请在使用时认真阅读。 合同编号：___________ 委托人：______________（以下称“甲方”） 住址：_____________ 法定代表人：______________ 电话：___________ 传真：_______________ 邮编：___________ 电子信箱：___________ 受托人：______________（以下称“乙方”） 住址：_____________ 法定代表人：______________ 电话：___________ 传真：_______________ 邮编：___________ 电子信箱：___________ 签约日期：_________ 签约地点：_________ 甲、乙双方经友好协商,就甲方委托乙方代理进口本合同项下货物一事达成一致,兹同意按照下述条款签订本合同：
一、甲方委托乙方代理进口下述货物（以下称“货物”） 货物名称：_______________ 规格：_______________ 数量：_______________ 品牌/商标：_______________ 其它：_______________ 二、委托项目 1.甲方委托乙方以乙方名义与__________以下称“外商”签订进口合同（以下称“进口合同”）,向其购买上述货物。 2.乙方向外商购买上述全部货物的总价为__________（不含税款及代理费） 3.进口合同中对货物的质量要求应为： 技术标准（标准制订人、标准名称、标准代号/编号等） 特别约定：_________________ 三、乙方义务 1.根据本合同的有关规定,以自己的名义与外商签订进口合同。 2.按照进口合同的规定,办理货物在中国境外的运输、保险事宜。 3.办理货物的进口报关、对外付汇手续。 4.按照本合同第六条的规定向甲方交付货物。 5.本合同规定的其它义务。
STANDARD AGREEMENT SAMPLE (协议范本) 甲方：____________________ 乙方：____________________ 签订日期：____________________ 编号：YB-HT-030863 委托代理进口协议(协议范
委托代理进口协议(协议范本) 协议号： 委托人：（以下简称甲方） 法定代表人： 地址：邮编： 电话：传真： 代理人：（以下简称乙方） 法定代表人： 地址：邮编： 电话：传真： 甲、乙双方经友好协商，就进口项目事宜,根据国家现行的法律、法规和政策之规定，于年月日在北京签订协议条款如下，以资信守。 一、甲方委托乙方作为其进口项目的代理人，乙方接受甲方委托，代理甲方对外签订和执行该项目进口合同。 二、甲方委托乙方代理进口项目。详细情况如下： 卖方： 地址：
电话：传真： 商品名称及规格： 单价： 数量： 总价： 价格条款： 付款方式及付款时间： 交货时间及运输方式： 制造商及原产地： [如上述情况不足以详尽说明，可设附件] 三、甲方义务： 1．负责按规定办理 □进口证明，□进口登记表，□免税证明，□进口许可证，□进口所需的卫生或食品部门的有关文件，□。 2．甲方对外所做的承诺或约定必须符合国家现行的法律、法规和政策的规定，并承担有关责任。同时，负责确保所进商品和商品进价的真实性。如因甲方原因造成到货通关时发生问题，其责任和直接损失，以及乙方按甲方委托要求履行合同过程中所产生的风险和损失都由甲方承担。 3．本协议签订后，甲方于年月日将货款总额的%计人民币元给付乙方；支付方式为。 4．甲方须在货到港前个工作日内，将进口税款（关税、增值税）和乙方进口代理手续费（为合同总金额的%）等款项给付乙方。如因款项未到，而造成滞
国际销售代理协议书 International Agential proposal Agreement 甲方：XXXX 地址 乙方：XXXX 地址 经双方平等、自愿协商，达成本销售代理协议，共同遵守。 Based on equality and mutual negotiations, both partners agree on this sales agential agreement. 第一条代理内容 1. The Contents of Agency 同意将下列产品瑞典CINIA TECH & TRADINGTECH公司(简称SSV)的产品及CINIA TECH & TRADINGTECH公司所代理的产品(简称产品)的代理权授予代 理方(简称代理人)。代理人优先在下列指定地区(简称地区)推销产品中国大庆采油六厂。代理方式可由以下三种方式一： CINIA TECH & TRADINGTECH AB (Here with named as SSV) agrees to authorize an agential right of SSV’s product or agential product sales to (.The agent ) . The agent has the initiative right to sell within the region of daqing sixth oil extraction factory. One agential method is to be selected from the following three means: 1-1 代理人直接与客户签订销售合同； 1-1 The agent signs the sales contract directly with the customer; 1-2 CINIA TECH & TRADING、代理人共同与用户签订销售合同 1-2 CINIA TECH & TRADING and the agent sign sales contract simultaneously. 1-3 CINIA TECH & TRADING直接于用户签订销售合同
IMPORT_AGENT_SERVICE_AGREEMENT 委托代理进口协议 甲、乙双方本着平等互利、共同发展的原则，经友好协商，自愿签定本协议： After frie ndly n egotiati ons betwee n the Parties and accord ing to the “Tentative Provisions on System of Foreign Trade Agency ” promulgated by the former PRC Mini stry of Econo mic and Trade, Party A and Party B have reached the follow ing agreeme nt: 一、甲方全权委托乙方代理进口产品及报关，承担乙方按照其指示或经其同意而进行操作的一切后果。 Party A hereby appo ints Party B as Party A's import age nt to provide import age nt services . 二、甲方应在实际进口之前将进口详细计划告之乙方，并提供产品的品名、数量、重 量、价格、产地、贸易国及HS编码，以便乙方及时开始准备工作。甲方应保证上述资 料完整准确，并做到单货相符、单单相符、单证相符。若因甲方提供信息有误或延迟而造成额外费用，甲方应承担全部责任。 Party A shall provide to Party B such detailed documents as the bill of lading and list of Goods to be imported indicating the prices, quantity, specificati ons, purposes and additi onal docume nts as requested by the compete nt authorities on a case by case basis. Party A shall immediately after arrival of the Goods at the port provide the releva nt docume nts to Party B. Party A shall in struct the exporter and en sure that the exporter issues a proper and complete set of customs cleara nee docume nts such as commercial in voices, pack ing lists, bills of ladi ng （or airway bills, etc. to the effect that all documents are consistent with each other and that all docume nts are con siste nt with the con diti ons of the Goods. The customs cleara nee shall be made accord ing to the facts. If it is found that the docume nts are not con siste nt with the Goods, Party A shall bear the releva nt liabilities. 三、甲方应积极配合乙方做好通关手续（随时提供海关所需资料），并提供必要协助。 Party A shall be prese nt at the in spect ion site desig nated by the customs authorities. 四、甲方应在每票操作结束后付给乙方进口代理费，代理费按进口合同金额的***%收取，若不足人民币***元，则按人民币***元收取。
委托代理进口协议书 协议编号： 签订日期： 签订地点： 甲方（委托人）： 地址： 电话：传真： 乙方（受托人）： 地址： 电话：传真： 根据《中华人民共和国民法通则》、《中华人民共和国合同法》等法律法规的相关规定，甲乙双方经友好协商，就甲方委托乙方代理向其指定的境外客户（下称“外商”）购买（下称“货物”）事宜，订立本协议： 一、委托事项 1.1 甲方委托乙方代理向外商进口和执行《购销合同》（合同编 号：；下称“《购销合同》”），该合同在签订前需经甲方以书面形式确认方可签订和执行。 1.2 外商及货物的基本情况： （1）外商名称： 外商地址： （2）货物名称： （3）规格及质量： （4）包装： （5）单价： （6）数量： （7）总价： （8）乙方向外商付款方式： （9）外商的发货时间及运输方式： （10）制造商及原产地： （11）其它条款：
二、委托内容 2.1 乙方受甲方委托以乙方的名义与外商签订《购销合同》，办理付 汇及核销手续。 2.2 乙方协助甲方准备进口所需的法律文件。 2.3 根据甲方的要求，乙方协助甲方办理下述事宜：□投保保险、□ 报关、□报检、□报验、□其他；相关费用由甲 方承担。 2.4 乙方在收到甲方的开证保证金后，在三个工作日内向外商开具远 期信用证。 2.5 货物进口后储存在乙方指定的仓库，乙方代表甲方与仓储方签署 仓储合同，仓储费用由甲方承担。 三、款项支付 3.1 保证金： （1）甲方在乙方开展委托工作前向乙方支付货物价值的%作为开证保证金，货物价值按照《购销合同》的金额暂计， 汇率按照暂计，暂计为：。 （如《购销合同》有短溢装条款，则按照溢装上限的标准 计收） （2）乙方在收到上述保证金后代理开具《购销合同》约定的信用证，用以支付《购销合同》项下款项。 （3）在甲方未付清本协议下应付款项前，如因汇率的变动或货物市场价值的下降，导致保证金比例下降，对于甲方未付 清余款的货物，乙方有权要求甲方补齐相关保证金差额并 保持货值比例%的保证金水平。 3.2 税款： （1）甲方在收到乙方通知支付税款金额后二个工作日内，向乙方支付货物的进口关税、增值税等税款，乙方收到款项后 代为办理缴纳。 （2）如果因任何非乙方的原因，造成的滞报和/或滞纳，可能因此而产生的罚金和一切后果由甲方承担。 3.3 货款：
代理协议书英文版范本 代理协议书英文版是怎么样的，怎么写英文版的代理协议书？下面是小编为大家收集的关于代理协议书英文版范本，欢迎大家阅读! Exclusive Agency Agreement 本协议于______年____月____日在______（地点）由有关双方在平等互利基础上达成，按双方同意的下列条件发展业务关系： This agreement is made and entered into by and between the parties concerned on ___________（Date） in ________（Place）on the basis of equality and mutual benefit to develop business on terms and conditions mutually agreed upon as follows: 1. 协议双方 The Parties Concerned 甲方：_______ 乙方：__________ Party A:________ Party B:________ 地址：__________ 地址：___________ Add:____________ Add:______________ 电话：__________ 电话：____________ Tel: ___________ Tel: _____________ 传真：_________ 传真：____________ Fax:___________ Fax:______________ 2. 委任
Appointment 甲方指定乙方为其代理，为第三条所列商品从第四条所列区域的顾客中招揽订单，乙方接受上述委任。 Party A hereby appoints Party B as its Exclusive Agent to solicit orders for the commodity stipulate in Article 3 from customers in the territory stipulated in Article 4,and Party B accepts and assumes such appointment. 3. 代理商品 Commodity 4. 代理区域 Territory 仅限于_______（比如：广州） In __________（for example: Guangzhou）only. 5. 最低业务量 Minimum turnover 乙方同意，在本协议有效期内从上述代理区域内的顾客处招揽的上述商品的订单价值不低于_______人民币。 Party B shall undertake to solicit orders for the above commodity from customers in the above territory during the effective period of this agreement for not less than RMB_________.
（以下简称甲方）与（以下简称乙方）以《供货合同》为基础，就甲方从乙方采购的材料、零件、单元或商品（以下简称订货产品）有关乙方质量保证签订如下协议。 第一节目的 第一条目的 乙方向甲方交纳的全部订货产品，必须符合甲方的制造、组装（以下称制造）的质量要求（包括但不限于结构、机能、性能、安全性等要求），乙方保证向甲方提供满足品质要求的订货产品。 第二节质量要求 第二条（质量要求规定） 1、乙方产品差不多质量要求按甲方最新颁布的企业技术 标准，甲方未提供企业技术标准时按相关国家或乙方企业 技术标准执行。甲方企业技术标准包括了产品要紧性能指 标及试验方法、检验规则、标志、包装、运输和储存等内 容。甲方验收乙方产品时以上述标准及甲方抽样标准为依 据，对质量标准有争议的，以封样样板为准。 2、有关订货产品的质量要求等，双方在乙方制造订货产品
前或交货前，须对以下图纸、规格书等进行确认，质量要 求等变更时必须确认。 （1）由甲方做成，正式交给乙方的图纸、规格书、样本等（汉甲方托付乙方做成之图纸、规格书、样品等， 以下称采购标准）。 （2）由乙方做成，甲方书面确认的图纸、规格书、样本等（以下称交货标准）。 3、乙方向甲方交货的产品，必须符合甲方向乙方订货的最 新采购标准或交货标准。 第三条（遵守法律、法规等） 1、乙方应遵守与安全性能相关的已制定的法律、条例等规 定。 2、乙方从甲方正式接收的采购标准，假如推断不能遵守前 项安全规定等时，要立即向甲方报告、协商。 第三节质量保证 第四条（建立质量保证体系） 1、为了确保订货产品满足甲方质量要求，乙方应通过对订 货产品的开发、设计、物资采购、制造、检查、保管、运 输等全过程的质量监控，确立经济且有效的质量保证体系。
编号：_____________委托代理进口协议 甲方：________________________________________________ 乙方：___________________________ 签订日期：_______年______月______日
签订日期： 签订地点： 甲方（委托人）： 地址： 电话：传真： 乙方（受托人）： 地址： 电话：传真： 根据《中华人民共和国民法通则》、《中华人民共和国合同法》等法律法规的相关规定，甲乙双方经友好协商，就甲方委托乙方代理向其指定的境外客户（下称“外商”）购买 （下称“货物”）事宜，订立本协议： 一、委托事项 1.1 甲方委托乙方代理向外商进口和执行《购销合同》（合同编号：；下称 “《购销合同》”），该合同在签订前需经甲方以书面形式确认方可签订和执行。 1.2 外商及货物的基本情况： （1）外商名称： 外商地址： （2）货物名称： （3）规格及质量： （4）包装： （5）单价： （6）数量： （7）总价：
（8）乙方向外商付款方式： （9）外商的发货时间及运输方式： （10）制造商及原产地： （11）其它条款： 二、委托内容 2.1 乙方受甲方委托以乙方的名义与外商签订《购销合同》，办理付汇及核销手续。 2.2 乙方协助甲方准备进口所需的法律文件。 2.3 根据甲方的要求，乙方协助甲方办理下述事宜：□投保保险、□报关、□报检、□报验、 □其他；相关费用由甲方承担。 2.4 乙方在收到甲方的开证保证金后，在三个工作日内向外商开具远期信用证。 2.5 货物进口后储存在乙方指定的仓库，乙方代表甲方与仓储方签署仓储合同，仓储费用由甲 方承担。 三、款项支付 3.1 保证金： （1）甲方在乙方开展委托工作前向乙方支付货物价值的 %作为开证保证金，货物价值按照《购销合同》的金额暂计，汇率按照暂计，暂计为：。（如《购销合同》有短溢装条款，则按照溢装上限的标准计收） （2）乙方在收到上述保证金后代理开具《购销合同》约定的信用证，用以支付《购销合同》项下款项。 （3）在甲方未付清本协议下应付款项前，如因汇率的变动或货物市场价值的下降，导致保证金比例下降，对于甲方未付清余款的货物，乙方有权要求甲方补齐相关保证金差额并保持货值比例 %的保证金水平。 3.2 税款： （1）甲方在收到乙方通知支付税款金额后二个工作日内，向乙方支付货物的进口关税、增值税等税款，乙方收到款项后代为办理缴纳。
销售代理协议 SALES AGENCY AGREEMENT 编号：No：日期：Date： 本协议双方为了发展贸易，在平等互利的基础上，按下列条件签定本协议。 This agreement is entered into between the parties concerned on the basis of equality and mutual benefit to develop business on terms and conditions mutually agreed upon as follows: 1. 订约人（Contracting Parties） 供货人： Supplier：（hereinafter called "Party A"） 销售代理人： Agent：（hereinafter called "Party B"） 甲方委托乙方为销售代理人，推销下列商品。 Party A hereby appoints party B to act as his selling agent to sell the commodity mentioned below. 2. 商品及数量或金额（Commodity and Quantity or amount） 双方约定，乙方在协议有效期内，承销不少于_____的上述商品。 It is mutually agreed that Party B shall undertake to sell not less than _____ of the aforesaid commodity in the duration of this Agreement. 3. 经销地区只限在_____销售。 Territory In_____only. 4. 定单的确认（Confirmation of orders） 关于协议所规定的上述商品的每笔交易，其数量、价格及装运条件等须经甲方确认，并签定销售确认书，对交易做具体规定。 The quantities, prices and shipment of the commodities stated in this Agreement shall be confirmed for each transaction, the particulars of which are to be specified in the Sales Confirmation signed by the two parties hereto. 5. 付款（Payment） 订单确认后，乙方须按照有关确认书所规定的时间开立以甲方为受益人的保兑的、不可撤消的即期信用证。乙方开出信用证后，应立即通知甲方，以便甲方准备交货。 After confirmation of the order, Party B shall arrange to open a confirmed, irrevocable L/C available by draft at sight in favor of Party A within the time stipulated in the relevant S/C. Party B shall also notify Party A immediately after L/C is opened, so that Party A can get prepared for delivery. 6. 佣金（Commission） 在本协议期满时，乙方完成了第二款所规定的数额，甲方当按装运货物所收到的 全部发票金额付给乙方_____%的佣金。 Upon the expiration of the Agreement and Party B's fulfillment of the total turnover mentioned in Article 2, Party A shall pay to Party B_____% commission on the basis of the aggregate amount of the invoice value already paid by Party B of the shipments affected. 7. 市场情况报告（Reports on Market Conditions）
代理商质量保证协议书 NO: 甲方（个人）： （以下简称甲方） 乙方（公司）： （以下简称乙方） 1、目的 为确保甲方质量，保证体制有效运行；确保乙方供货质量的稳定，满足甲方用户的最终产品需求，防止不合格品配套的发生，特签定本协议。 2、适应范围 本协议适应提供甲方产品配套的乙方。 3、双方合同涉及的内容 3.1甲方向乙方下达的合同订单应当准确无误的标明：产品名称、型号规格、交货期限、交货方式、质量保证期限。 3.2甲方如需要对已下达，但尚未执行的合同（订单）内容进行更改，必须以书面的形式通知乙方，乙方应及时向甲方代表确认并纠正合同（订单）内容。 3.3甲方向乙方下达的合同订单，应附加工、购买产品的质量技术指标、要求。如甲方不能明确提出的质量技术指标可使用国家标准或由乙方代为提出，双方同意后形成书面记录。 4、质量标准的说明 4.1甲方通过图纸、标准或指定样件等方式，向乙方说明产品的质量标准。 4.2对甲方提出的质量标准有异议时，或者希望变更时，乙方须向甲方提出申请，进行协商确定。 4.3乙方向甲方提供的产品合格率： 产品不得低于%，质量保证期年。 产品不得低于%，质量保证期年。 产品不得低于%，质量保证期年。 产品不得低于%，质量保证期年。 5、质量检查确认 5.1乙方根据双方协定的质量标准要求，出具乙方每批次的《产品出厂检验报告》，必要时，应甲方要求，乙方应提交乙方产品的《检验基准书》、《QC工程表》及其他此产品质量证明资料给甲方确认。 5.2质量检查供货初期在进行，正常时在
进行。 5.3属双方协定或国家强制性检验的项目，甲方或乙方不能完成检验时，必须在甲方质量管理部门指定的国家试验机构进行，检验发生费用由乙方承担。 5.4甲方在认为必要的时候，可以随时到乙方的生产现场，对配套件进行检查，或是对乙方的质量保证体系进行监察。 5.5当乙方的生产场地发生改变或关键工序、设备发生改变时必须通知甲方并得到甲方的认可。 6、乙方的赔偿责任 对于配套发生的问题符合下面某一项时，乙方要负责下述7.1所约定的赔偿责任。A：未使用的乙方产品完全不符合甲方的质量技术要求； B：乙方单方面原因不能按时交货，影响甲方产品的交货时间； C：配套件经乙方货源地验货后，由乙方保管不善或维护不好或运输过程造成的问题（本条款适用由乙方保管运输的产品）； D：乙方供应产品在甲方地检验的零散不合格品； E：乙方产品已验收，甲方在生产过程中发现乙方产品超过（含）3%不符合甲方的质量要求； F：由乙方不合格引起的甲方产品售后维修、退货、运输等费用； G：甲方无法判断，乙方出厂合格，而实际与要求质量不符合，造成的其他问题；H：当乙方向甲方提供的批次产品合格率低于4.3项1个百分点； J：当乙方向甲方提供的批次产品合格率低于4.3项2个百分点； K：因甲方客户需要，经与乙方协商同意，批次合格率低于上述J条百分点。 7、索赔 7.1当乙方产品符合本协议第6项各子项内容时，乙方应按下述第6项各子项相对应的
甲方（委托方）： 法定代表人： 乙方（受托方）： 法定代表人： 根据《中华人民共和国对外贸易法》、《中华人民共和国合同法》及其他相关法律法规，甲乙双方就代理进口事宜，本着互利互惠的原则，经友好协商，达成协议如下： 第一条总则 1.1 本协议是甲乙双方为建立长期的进口代理关系而签订。乙方根据甲方的委托，从境外供货处进口附件一所述货物，并提供所述货物之物流服务。 1.2 本协议未约定的具体代理事宜根据本协议附件执行，甲乙双方可以根据具体情况，在协商一致的条件下对附件一进行变更。 1.3本协议未尽事宜，双方应首先根据上述法律及双方在签订协议时达成的基本原则协商解决。 第二条进口代理 2.1甲方就每批货物编制委托单（委托单是指甲方向乙方发出的委托进口货物确认单、订单、INVOICE、采购合同等具有明确的货物名称、数量、单价的文件），列明每批进口货物的产品名称、规格型号、数量、进口单价、产地、装箱情况、要求的交货期等资料，甲方委托乙方代理之货物以委托单为准，并于境外供货商发货期前两个工作日交给乙方,以便乙方办理货物进口的相关手续及做好相关准备工作。 2.2甲方向乙方发出委托单的，视为甲方同意委托乙方代理该等进口事宜并依本协议履行义务；乙方可以根据自身情况决定是否接受甲方的委托。 2.3从甲方指定电子邮箱、传真或其它网络通信工具发至乙方的委托单等信息（不论是否经甲方盖章或甲方授权代表签字）均视为甲方同意委托乙方依据本协议约定代理该委托事项，乙方根据该委托单履行代理行为的，甲方不得以任何理由抗辩。
第三条甲方的义务、责任 3.1 甲方就本协议及委托单承担其作为委托方的义务。 3.2 甲方应及时满足乙方的要求，向乙方提供有关业务所需的信息及资料。 3.3甲方应当依照本协议约定支付代理进口货物价款、乙方代垫款项和有关费用。 3.4 甲方应保证报关货物产品名称、规格型号、数量、进口单价、产地、装箱情况等有关信息的真实准确及合法，否则，所引起的一切经济及法律责任全部由甲方负责。 3.5 除本协议第六条6.5中所述的货物责任之外，甲方不得就货物灭失、货物价格发生变动、货物质量纠纷、货物知识产权纠纷、货物安装、维修、退货、换货等其他任何纠纷或事宜向乙方要求索赔、承担任何责任、或履行任何义务。甲方如因与境外供货商或其他方解决上述纠纷或事宜导致乙方支付有关费用或受到任何损失，甲方须给予乙方全额赔偿。 第四条乙方的义务、责任 4.1 乙方保证自己在其经批准的对外贸易经营范围内进行经营活动。 4.2 乙方应及时报告对外开展业务的进度及履行乙方义务的情况。 4.3 乙方有义务办理履行代理进口时所需的各种手续。 4.4 乙方有义务为甲方保守商业秘密，未获甲方事先书面同意，不得向任何第三人透露甲方客户及交易的情况，但根据有关政府机关或法院要求透露的不在此限。 4.5 因乙方原因逾期交货超过三个工作日的，甲方有权从逾期之日起每天按进口代理费的_______%向乙方收取逾期交货滞纳金；逾期超过60天的，滞纳金率按每天_______计算；乙方支付给甲方滞纳金的，由甲方开具地税发票给乙方。 第五条代理进口货物价款、进口代理费、通关及其支付和结算 5.1代理进口货物价款及具体进口货物清单、数量和单价由委托单确认。甲方提供的价款过分低于国际市场行情，有可能虚报价格的，乙方有权根据国际市场行情对进口货物价格进行调整。5.2 进口代理费、进口货物货款及税款支付结算办法详见附件一。 5.3 如需乙方代垫货款、代开信用证或期票的，在甲方未向乙方付清全额货款、税款及代理费前，货物所有权属于乙方。