质量协议书中英

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 “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 other’s 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 responsibility

1、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 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 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 national requirements 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 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》