质量协议书中英完整版.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)供应双方根据中华人民共和国管理法、中华人民共和国产品质量法、药品生产质量管理规定及有关法律、法规的要求，明确药品经营质量责任，保证药品质量，经甲乙双方协商达成如下协议，并共同遵守。According to “thePeoplesRepublicofChina(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 responsibility1、甲乙双方同意各自充分考虑对方的需求，相互交换产品质量的必要情报。Both sides agree to fully consider each others demand, exchange necessary information of product quality.2、甲方收到乙方供货产品时应根据随货同行的原厂检验报告和销售凭证验收，发现短少、破损或外包装损坏时应及时通知乙方，乙方负责处理有问题的产品。 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、甲方收货后及时检验，如有质量问题应对乙方提出，如经双方确认，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、甲方根据本公司规定的供应商质量评估和批准标准管理要求对乙方进行审计和评估。 Party A audit and evaluate Party B as their own supplier quality evaluation and permission procedure.二、乙方义务：Party B responsibility1、甲乙双方同意各自充分考虑对方的需求，相互交换产品质量的必要情报。甲方有义务向乙方提供所需产品的质量标准，乙方在不违反药品法的前提下提供相应产品；乙方所提供的产品，必须满足现行中国药品标准。Both sides agree to fully consider each others 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 currentChina drug standard.2、乙方应为合法的生产或经营企业。乙方向甲方提供合法有效并加盖本企业公章的营业执照、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，应及时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 withthe official seal of the enterprise for audit. Party B must timely provide newcopycertificateaffixed withthe official seal of the enterprise when annual examination, renew or change license.3、乙方供应的商品必须符合质量标准和有关质量要求，附产品合格证，符合国家包装、标签、说明书、标志标识的有关规定和货物运输的要求。 The product supplied by Party B must meet with specification & related quality demand and along with qualified certificate. Also, the product must comply with nationalrequirements of packaging,labels and instruction and requirements of goods transportation condition.4、乙方应提供甲方对供应商质量评估和批准标准管理要求予以配合，按甲方提出的合理的缺陷要求进行整改，整改完成后经甲方确认列为合格供应商后，方可采购。 Party B must cooperate with Party Ato complete theParty B qualityevaluation & approvalprocedure 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的销售凭证和本批合格的原厂检验报告随货同行给甲方，供验明商品的合法来源。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、有效期、数量、储存条件等内容。若乙方不能及时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 Asreceipt,acceptanceandremittancepayment.6、乙方向甲方销售商品时，应当按照有关规定储存和运输，以保证产品质量。若乙方不能做到按照有关规定储存和运输，由此造成的拒收退货、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 asrelevant provisions to ensure product quality. Party B must responsible for product rejection, product quality problem, economic loss or any penaltiesand forfeitures by SFDA that caused by improper storage or transport. 7、乙方供应的商品应符合甲方效期及数量批号比例要求。来货商品有效期一年以内的，生产日期距收货日期不得超过3个月；有效期一年以上的，生产日期距收货日期不得超过6个月。来货10件以下的只能为一个批号；50件以下不得超过2个批号。 The supplied products must comply with shelf life and quantity& Batch No. ratio as Party As demand. The incominggoodsvalid date iswithin one year,the date ofproduction must not exceed 3 monthsfrom date of receipt; valid date isabove one year,the date ofproduction must not exceed 6 monthsfrom the date of receipt.If incoming goods is less than 10 pieces, it can only foronebatch number;if incoming goods is less than 50 pieces, it must be not more thantwobatch numbers.8、双方在交货验收时，应当面点清件数，甲方在收货后发现箱内货物短少、破损等情况时，可持有效证明要求乙方补货。因甲方保管养护不当造成的质量问题，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 ordamage, 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、 因乙方商品质量导致下列情况时，依照以下约定执行，并依据情节双方协商，对甲方做出经济损失和信誉损失的补偿并承担相应的法律责任。 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. 因乙方商品质量导致甲方产品遭到顾客投诉，经查属实的，乙方须向甲方退还货款、并补偿甲方信誉损失和经济损失并承担相应的法律责任；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的，乙方须向甲方退还货款，并补偿甲方信誉损失和经济损失并承担相应的法律责任； 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的，乙方须向甲方退还货款、并补偿甲方信誉损失和经济损失并承担相应的法律责任。 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系，作为退货处理，需要发运的应向甲方采购员及时提出，甲方暂存货物，乙方应及时办理提货。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明。 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 storageof 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. 有严重质量问题的商品；The goods have critical quality problem;b. 已补新货，但甲方不提回退货的；Replenishment has finished but Party A didnt deliver rejection goods.c. 商品超过有效期限的；Goods exceed their shelf life.d. 包装破损、渗漏、污染的退货商品，且退货后乙方2个月不提货的； Party B has not delivered packing breakage,leakage or polluted goods over 2 months from rejection.e. 没有标明有效期限的退货商品，且退货后乙方2个月不提货的。 Party B has not delivered goods without shelf life over 2 months from rejection.11、乙方的单位名称、地址、账号、税号及销售员等发生变化，应提前以书面公函形式通知甲方，如因乙方通知不及时，造成货物、货款的经济损失，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 notificationis not timely.12、乙方若出现以下情况，由乙方负责退还货款、补偿甲方信誉损失并承担相应的法律责任。 Party B responsible for refund payment,compensationto party A at theloss of credibilityandbear the corresponding legal responsibility in the following situations.a. 乙方应保证向甲方销售的货物不含有GMO(转基因) ；Party B ensures the supplied goods are not containing GMO（transgenosis）.b. 乙方应保证向甲方销售的货物不含有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 spongiformencephalopathy/bovine spongiform encephalopathyBSE).c. 乙方应保证向甲方销售的货物不含有三聚氰胺/三聚氰酸、有机溶剂的残留； Party B ensures the supplied goods are not containing melamine / cyanuricacid,organic solvent residues.d. 乙方应保证向甲方销售的货物不含有杀虫剂残留； Party B ensures the supplied goods are not containing pesticide residues.e. 乙方应保证向甲方销售的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 asaflatoxin,dioxin etc.f. 乙方应保证向甲方销售的货物不含有金属催化剂残留； Party B ensures the supplied goods are not containing metal cat