1、質量協(xié)議書中英編制僅供參考審核批準生效日期地址： 電話：傳真: 郵編:質量協(xié)議書Quality agreement甲方（進貨單位）：Party A (Purchase)乙方（供貨單位）：Party B(Supplier)供應雙方根據(jù)中華人民共和國管理法、中華人民共和國產品質量法、藥品生產質量管理規(guī)定及有關法律、法規(guī)的要求，明確藥品經(jīng)營質量責任，保證藥品質量，經(jīng)甲乙雙方協(xié)商達成如下協(xié)議，并共同遵守。According to “thePeoplesRepublicofChina(PRC) management law”, “PRC product quality law”, “Good Manuf

2、acturing 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、甲方義務 Party A responsibility1、甲乙雙方同意各自充分考慮對方的需求，相互交換產品質量的必要情報。Both sides agree to fully consider each others deman

3、d, exchange necessary information of product quality.2、甲方收到乙方供貨產品時應根據(jù)隨貨同行的原廠檢驗報告和銷售憑證驗收，發(fā)現(xiàn)短少、破損或外包裝損壞時應及時通知乙方，乙方負責處理有問題的產品。 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 responsi

4、ble for handling problem product.3、甲方收貨后及時檢驗，如有質量問題應對乙方提出，如經(jīng)雙方確認，為乙方質量問題，甲方有權退貨。 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、甲方根據(jù)本公司規(guī)定的供應商質量評估和批準標準管理要求對乙方進行

5、審計和評估。 Party A audit and evaluate Party B as their own supplier quality evaluation and permission procedure.二、乙方義務：Party B responsibility1、甲乙雙方同意各自充分考慮對方的需求，相互交換產品質量的必要情報。甲方有義務向乙方提供所需產品的質量標準，乙方在不違反藥品法的前提下提供相應產品；乙方所提供的產品，必須滿足現(xiàn)行中國藥品標準。Both sides agree to fully consider each others demand, exchange nec

6、essary 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、乙方應為合法的生產或經(jīng)營企業(yè)。乙方向甲方提供合法有效并加蓋本企業(yè)公章的營業(yè)執(zhí)照、組織機構代碼證、稅務登記證、藥品生產許可證或藥品經(jīng)營許可證等有效證件供甲方審驗

7、資質。乙方在年審、換證或變更證照時，應及時向甲方提供新證照復印件并加蓋本企業(yè)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 enterpr

8、ise for audit. Party B must timely provide newcopycertificateaffixed withthe official seal of the enterprise when annual examination, renew or change license.3、乙方供應的商品必須符合質量標準和有關質量要求，附產品合格證，符合國家包裝、標簽、說明書、標志標識的有關規(guī)定和貨物運輸?shù)囊蟆?The product supplied by Party B must meet with specification & related qualit

9、y 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、乙方應提供甲方對供應商質量評估和批準標準管理要求予以配合，按甲方提出的合理的缺陷要求進行整改，整改完成后經(jīng)甲方確認列為合格供應商后，方可采購。 Party B must cooperate with Party At

10、o complete theParty B qualityevaluation & approvalprocedure and finish CAPAs. Purchase from Party B after evaluation and permission it as qualified supplier.5、乙方向甲方銷售商品時，應開具加蓋本企業(yè)銷售或發(fā)貨公章的銷售憑證和本批合格的原廠檢驗報告隨貨同行給甲方，供驗明商品的合法來源。銷售憑證應標明供貨單位名稱、貨物名稱、規(guī)格、生產廠商、生產批號、生產日期、有效期、數(shù)量、儲存條件等內容。若乙方不能及時提供銷售憑證將會影響甲方收貨、驗收和向乙

11、方匯付貨款。 “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 vouch

12、er” on time, it will effect Party Asreceipt,acceptanceandremittancepayment.6、乙方向甲方銷售商品時，應當按照有關規(guī)定儲存和運輸，以保證產品質量。若乙方不能做到按照有關規(guī)定儲存和運輸，由此造成的拒收退貨、產品質量問題、經(jīng)濟損失或藥監(jiān)罰沒由乙方負責。 Party B must storage and transport asrelevant provisions to ensure product quality. Party B must responsible for product rejection, produc

13、t quality problem, economic loss or any penaltiesand forfeitures by SFDA that caused by improper storage or transport. 7、乙方供應的商品應符合甲方效期及數(shù)量批號比例要求。來貨商品有效期一年以內的，生產日期距收貨日期不得超過3個月；有效期一年以上的，生產日期距收貨日期不得超過6個月。來貨10件以下的只能為一個批號；50件以下不得超過2個批號。 The supplied products must comply with shelf life and quantity& Batc

14、h 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 f

15、oronebatch number;if incoming goods is less than 50 pieces, it must be not more thantwobatch numbers.8、雙方在交貨驗收時，應當面點清件數(shù)，甲方在收貨后發(fā)現(xiàn)箱內貨物短少、破損等情況時，可持有效證明要求乙方補貨。因甲方保管養(yǎng)護不當造成的質量問題，由甲方負責。甲方收貨時應該做相關檢驗，若為不合格品，應拒收退貨，由乙方負責。 Both sides must check pieces quantity when receiving goods. Once found goods inside is sh

16、ortage 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、 因乙方商品質量導致下列情況時，依照以下約定執(zhí)行，并依據(jù)情節(jié)雙方協(xié)商，對甲方做出經(jīng)濟損失和

17、信譽損失的補償并承擔相應的法律責任。 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.因乙方商品質量導致甲方產品遭到顧客投訴，經(jīng)查屬實的，乙方須向甲方退還貨款、并補償甲方信譽損失和經(jīng)濟損失并承擔相應的法律責任；Party B must return goods payment,

18、 compensate for economic loss and credit loss and bear legal responsibility caused by Party A goods problem and lead complaints.因乙方商品質量遭到政府行政主管部門假劣商品處罰的，乙方須向甲方退還貨款，并補償甲方信譽損失和經(jīng)濟損失并承擔相應的法律責任； Party B must return goods payment, compensate for economic loss and credit loss and bear legal responsibility

19、caused by Party A goods problem and lead punishment by administrative department.因乙方商品遭到媒體曝光的，乙方須向甲方退還貨款、并補償甲方信譽損失和經(jīng)濟損失并承擔相應的法律責任。 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

20、.10、因乙方商品質量問題，經(jīng)甲方采購員與乙方銷售員聯(lián)系，作為退貨處理，需要發(fā)運的應向甲方采購員及時提出，甲方暫存貨物，乙方應及時辦理提貨。下列情況視同乙方委托甲方銷毀有質量問題退貨商品，甲方銷毀后，乙方可向甲方質量管理部門索取銷毀證明。 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

21、 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.有嚴重質量問題的商品；The goods have critical quality problem;已補新貨，但甲方不提回退貨的；Replenishment ha

22、s finished but Party A didnt deliver rejection goods.商品超過有效期限的；Goods exceed their shelf life.包裝破損、滲漏、污染的退貨商品，且退貨后乙方2個月不提貨的； Party B has not delivered packing breakage,leakage or polluted goods over 2 months from rejection.沒有標明有效期限的退貨商品，且退貨后乙方2個月不提貨的。 Party B has not delivered goods without shelf lif

23、e over 2 months from rejection.11、乙方的單位名稱、地址、賬號、稅號及銷售員等發(fā)生變化，應提前以書面公函形式通知甲方，如因乙方通知不及時，造成貨物、貨款的經(jīng)濟損失，由乙方負責。 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 time

24、ly.12、乙方若出現(xiàn)以下情況，由乙方負責退還貨款、補償甲方信譽損失并承擔相應的法律責任。 Party B responsible for refund payment,compensationto party A at theloss of credibilityandbear the corresponding legal responsibility in the following situations.乙方應保證向甲方銷售的貨物不含有GMO(轉基因) ；Party B ensures the supplied goods are not containing GMO（transgen

25、osis）.乙方應保證向甲方銷售的貨物不含有TSE/BSE(傳染性海綿狀腦病/牛海綿狀腦病瘋牛病)； Party B ensures the supplied goods are not containing TSE/BSE (Transmissible spongiformencephalopathy/bovine spongiform encephalopathyBSE).乙方應保證向甲方銷售的貨物不含有三聚氰胺/三聚氰酸、有機溶劑的殘留； Party B ensures the supplied goods are not containing melamine / cyanuricac

26、id,organic solvent residues.乙方應保證向甲方銷售的貨物不含有殺蟲劑殘留； Party B ensures the supplied goods are not containing pesticide residues.乙方應保證向甲方銷售的貨物不含有毒素殘留，如黃曲霉素、二氧（雜）芑等； Party B ensures the supplied goods are not containing toxin residues, such asaflatoxin,dioxin etc.乙方應保證向甲方銷售的貨物不含有金屬催化劑殘留； Party B ensures the supplied goods are not containing met