质量协议书中英模板.docx

质量协议书
Quality agreement

甲方（进货单位）:
Party A (Purchase)
乙方（供货单位）:
Party B(Supplier)
供给双方依据《中国管理法》、 《中国产品质量法》、 《药品生产质量管理要求》及相关法律、 法规要求, 明确药品经营质量责任, 确保药品质量, 经甲乙双方协商达成以下协议, 并共同遵守。
According to “the People's Republic of China(PRC) management law”, “PRC product quality law”, “Good Manufacturing Practice” and related laws and regulations, clear drug supply quality responsibility and ensure drug quality, both sides have reached the following agreement and must abide by.
一、 甲方义务 Party A responsibility
1、 甲乙双方同意各自充足考虑对方需求, 相互交换产品质量必需情报。
Both sides agree to fully consider each other’s demand, exchange necessary information of product quality.
2、 甲方收到乙方供货产品时应依据随货同行原厂检验汇报和《销售凭证》验收, 发觉短少、 破损或外包装损坏时应立刻通知乙方, 乙方负责处理有问题产品。
Party A must do primary test according to manufacturer COA and “sales voucher” along with product. If found any loss or broken, informs Party B immediately. Party B is responsible for handling problem product.
3、 甲方收货后立刻检验, 如有质量问题应对乙方提出, 如经双方确定, 为乙方质量问题, 甲方有权退货。
Party A must test in time after receiving product. If quality has any problem, informs Party B and verifies by both sides. Party A has the right to reject product if quality has problem.
4、 甲方依据本企业要求供给商质量评定和同意标准管理要求对乙方进行审计和评定。
Party A audit and evaluate Party B as their own supplier quality evaluation and permission procedure.
二、 乙方义务: Party B responsibility
1、 甲乙双方同意各自充足考虑对方需求, 相互交换产品质量必需情报。甲方有义务向乙方提供所需产品质量标准, 乙方在不违反《药品法》前提下提供对应产品; 乙方所提供产品, 必需满足现行中国药品标准。
Both sides agree to fully consider each other’s demand, exchange necessary information of product quality. Party A has responsibility to supply product specification and Party B offers products on the premise of abide by “Drug Act”. The product must meet with current China drug standard.
2、 乙方应为正当生产或经营企业。乙方向甲方提供正当有效并加盖本企业公章营业执照、 组织机构代码证、 税务登记证、 药品生产许可证或药品经营许可证等有效证件供甲方审验资质。乙方在年审、 换证或变更证照时, 应立刻向甲方提供新证照复印件并加盖本企业公章。
Party B must be a legal manufacturer or business enterprise. Party B offer qualifications including business license, organization code certificate, tax registration certificate, GMP certificate or GSP certificate affixed with the official seal of the enterprise for audit. Party B must timely provide new copy certificate affixed with the official seal of the enterprise when annual examination, renew or change license.
3、 乙方供给商品必需符合质量标准和相关质量要求, 附产品合格证, 符合国家包装、 标签、 说明书、 标志标识相关要求和货物运输要求。
The product supplied by Party B must meet with specification & related quality demand and along with qualified certificate. Also, the product must comply with national requirements of packaging, labels and instruction and requirements of goods transportation condition.
4、 乙方应提供甲方对供给商质量评定和同意标准管理要求给予配合, 按甲方提出合理缺点要求进行整改, 整改完成后经甲方确定列为合格供给商后, 方可采购。
Party B must cooperate with Party A to complete the Party B quality evaluation & approval procedure and finish CAPAs. Purchase from Party B after evaluation and permission it as qualified supplier.
5、 乙方向甲方销售商品时, 应开具加盖本企业销售或发货公章《销售凭证》和本批合格原厂检验汇报随货同行给甲方, 供验明商品正当起源。《销售凭证》应标明供货单位名称、 货物名称、 规格、 生产厂商、 生产批号、 生产日期、 使用期、 数量、 储存条件等内容。若乙方不能立刻提供《销售凭证》将会影响甲方收货、 验收和向乙方汇付货款。
“Sales voucher” with stamped and COA must be along with products to identify its legal resource. “Sales voucher” including supplier name, product name, specification, manufacturer, Batch No., manufacturing date, valid date, quantity and storage condition. If Party B cannot supply “Sales voucher” on time, it will effect Party A’s receipt, acceptance and remittance payment.
6、 乙方向甲方销售商品时, 应该根据相关要求储存和运输, 以确保产品质量。若乙方不能做到根据相关要求储存和运输, 由此造成拒收退货、 产品质量问题、 经济损失或药监罚没由乙方负责。
Party B must storage and transport as relevant provisions to ensure product quality. Party B must responsible for product rejection, product quality problem, economic loss or any penalties and forfeitures by SFDA that caused by improper storage or transport.
7、 乙方供给商品应符合甲方效期及数量批号百分比要求。来货商品使用期一年以内, 生产日期距收货日期不得超出3个月; 使用期一年以上, 生产日期距收货日期不得超出6个月。来货10件以下只能为一个批号; 50件以下不得超出2个批号。
The supplied products must comply with shelf life and quantity& Batch No. ratio as Party A’s demand. The incoming goods valid date is within one year, the date of production must not exceed 3 months from date of receipt; valid date is above one year, the date of production must not exceed 6 months from the date of receipt. If incoming goods is less than 10 pieces, it can only for one batch number; if incoming goods is less than 50 pieces, it must be not more than two batch numbers.
8、 双方在交货验收时, 应该面点清件数, 甲方在收货后发觉箱内货物短少、 破损等情况时, 可持有效证实要求乙方补货。因甲方保管养护不妥造成质量问题, 由甲方负责。甲方收货时应该做相关检验, 若为不合格品, 应拒收退货, 由乙方负责。
Both sides must check pieces quantity when receiving goods. Once found goods inside is shortage or damage, Party B can ask Party A to replenishment. Party A responsible for quality problem caused by improper storage. Party A must do related test on the receipt of goods. If goods are unqualified, reject. Party B responsible for the rejection.
9、 因乙方商品质量造成下列情况时, 依据以下约定实施, 并依据情节双方协商, 对甲方做出经济损失和信誉损失赔偿并负担对应法律责任。
Execute as following provisions if occurs goods quality problem. Negotiate by both sides to compensate and bear legal responsibility for economic loss and credit loss caused by Party A.
a. 因乙方商品质量造成甲方产品遭到用户投诉, 经查属实, 乙方须向甲方退还货款、 并赔偿甲方信誉损失和经济损失并负担对应法律责任;
Party B must return goods payment, compensate for economic loss and credit loss and bear legal responsibility caused by Party A goods problem and lead complaints.
b. 因乙方商品质量遭到政府行政主管部门假劣商品处罚, 乙方须向甲方退还货款, 并赔偿甲方信誉损失和经济损失并负担对应法律责任;
Party B must return goods payment, compensate for economic loss and credit loss and bear legal responsibility caused by Party A goods problem and lead punishment by administrative department.
c. 因乙方商品遭到媒体曝光, 乙方须向甲方退还货款、 并赔偿甲方信誉损失和经济损失并负担对应法律责任。
Party B must return goods payment, compensate for economic loss and credit loss and bear legal responsibility caused by the media exposure owing to Party A goods problem.
10、 因乙方商品质量问题, 经甲方采购员与乙方销售员联络, 作为退货处理, 需要发运应向甲方采购员立刻提出, 甲方暂存货物, 乙方应立刻办理提货。下列情况视同乙方委托甲方销毁有质量问题退货商品, 甲方销毁后, 乙方可向甲方质量管理部门索取《销毁证实》。
Party A purchaser contact with Party B seller to reject goods owning to goods quality problem. Party A purchaser put forward shipping in time and temporary storage of goods, Party B must deliver goods in time. Party B can destroy quality problem goods in the following situations. Party B could ask for “Destruction certificate” from quality management department of Party A after goods destruction.
a. 有严重质量问题商品;
The goods have critical quality problem;
b. 已补新货, 但甲方不提回退货;
Replenishment has finished but Party A didn’t deliver rejection goods.
c. 商品超出使用期限;
Goods exceed their shelf life.
d. 包装破损、 渗漏、 污染退货商品, 且退货后乙方2个月不提货;
Party B has not delivered packing breakage, leakage or polluted goods over 2 months from rejection.
e. 没有标明使用期限退货商品, 且退货后乙方2个月不提货。
Party B has not delivered goods without shelf life over 2 months from rejection.
11、 乙方单位名称、 地址、 账号、 税号及销售员等发生改变, 应提前以书面公函形式通知甲方, 如因乙方通知不立刻, 造成货物、 货款经济损失, 由乙方负责。
If Party B changes name, address, account number or seller, inform Party A in advance by written form. Party B must responsible for the loss of goods and payment owning to notification is not timely.
12、 乙方若出现以下情况, 由乙方负责退还货款、 赔偿甲方信誉损失并负担对应法律责任。
Party B responsible for refund payment, compensation to party A at the loss of credibility and bear the corresponding legal responsibility in the following situations.
a. 乙方应确保向甲方销售货物不含有GMO(转基因) ;
Party B ensures the supplied goods are not containing GMO（transgenosis）.
b. 乙方应确保向甲方销售货物不含有TSE/BSE(传染性海绵状脑病/牛海绵状脑病——疯牛病);
Party B ensures the supplied goods are not containing TSE/BSE (Transmissible spongiform encephalopathy / bovine spongiform encephalopathy— BSE).
c. 乙方应确保向甲方销售货物不含有三聚氰胺/三聚氰酸、 有机溶剂残留;
Party B ensures the supplied goods are not containing melamine / cyanuric acid, organic solvent residues.
d. 乙方应确保向甲方销售货物不含有杀虫剂残留;
Party B ensures the supplied goods are not containing pesticide residues.
e. 乙方应确保向甲方销售货物不含有毒素残留, 如黄曲霉素、 二氧（杂）芑等;
Party B ensures the supplied goods are not containing toxin residues, such as aflatoxin, dioxin etc.
f. 乙方应确保向甲方销售货物不含有金属催化剂残留;
Party B ensures the supplied goods are not containing metal catalyst residues.
三、 协议说明 Agreement states
1、 本协议书为《购销协议》有效组成部分, 与其含有相同法律效力。
This agreement is a part of “purchase and sale contract”, and has the same legal effect as the contract.
2、 本协议书未尽事宜, 按国家法律法规条例实施, 或由双方协商处理, 协商不成, 可向甲方所在地法院（仲裁委员会）申请仲裁。
The details didn’t mentioned in this agreement must execute as state laws & regulations, or through negotiation by both sides. If negotiation is failed, seeks Party A local court (the arbitration commission) for arbitration.
3、 本协议书一式二份, 双方各执一份, 自甲乙双方法定代表人授权代表签字盖章之日生效。
This agreement is made in two copies, both sides have a copy. This agreement shall become effective on the date when it is signed and sealed 
by legal representatives or authorized representatives of both parties.

甲方（公章）: 乙方（公章）:
Party A (Stamped) Party B(Stamped)

甲方授权代表(签字): 乙方授权代表（签字）:
Party A representative（Signature） Party B representative（Signature）

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