RULES OF BRAZIL’S CONTRACT AND/OR QUALITY CONTROL
OF MEDICINE MANUFACTURING
 
第17條. 生產(chǎn)合同和／或質(zhì)量控制
MANUFACTURING CONTRACT AND/OR QUALITY CONTROL
 
17.1.       生產(chǎn)和或檢驗(yàn)合同應(yīng)經(jīng)雙方協(xié)商訂立，避免出現(xiàn)造成不合格程序、產(chǎn)品或檢驗(yàn)錯(cuò)誤。合同應(yīng)由雙方采用書面形式詳細(xì)確定GMP/GLP方面的責(zé)任，各個(gè)部分的明確特點(diǎn)包括質(zhì)量措施,和與產(chǎn)品放行和檢驗(yàn)報(bào)告簽發(fā)相關(guān)的方面     
The manufacturing and/or analysis contract should be mutually agreed between the parts, in a way to avoid mistakes that can result in a process, product or analysis of unsatisfactory quality. It should be firmed a written contract between the contractor and the contracted defining in details the GMP/GLP responsibilities and establish clearly the attributions of each part, including the quality measures, about the release of each product lot for selling or about emission of certificate of analysis.    
 
17.2.       合同的所有內(nèi)容應(yīng)符合GMP/GLP。應(yīng)特別考慮防止交叉污染,并具有可追溯性
All involved in the contract should comply with the GMP/GLP. It should be given special consideration to prevention of cross-contamination and traceability.
 
17.3.       除非經(jīng)雙方同意，不得變更工藝、設(shè)備、檢驗(yàn)方法、標(biāo)準(zhǔn)和其它合同要求
Changes in the process, equipment, analysis method, specifications, or other contractual demands should not be made, except if both parts are informed and changes approved.
 
17.4.       書面合同應(yīng)規(guī)定中間品和／或藥物成分的生產(chǎn)程序和/或檢驗(yàn)方法
The firmed written contract should establish manufacturing procedures and/or analysis of intermediate or pharmaceutical input with all technical activities to both related.
 
17.5.       合同應(yīng)規(guī)定發(fā)包人可審核承包人設(shè)施，以便確認(rèn)是否符合
 GMP/GLPThe contract should establish that the contractor can audit the contract's facilities, in order to verify the conformity with GMP/GLP. 
 
17.6.       對于檢驗(yàn)合同，應(yīng)有經(jīng)過授權(quán)的人員最終批準(zhǔn)中間品和藥物成分的放行In case of analysis contract, foreseen in the actual legislation, the final approval for release of intermediate and pharmaceutical input for commercialization should be performed by contractor's authorized person. 
 
17.7.       發(fā)包人向承包人提供所有必要的信息，使承包人按照中間品和藥物成分的標(biāo)準(zhǔn)進(jìn)行操作。發(fā)包人應(yīng)保證承包人了解有關(guān)中間品、藥物成分、服務(wù)或檢驗(yàn)的所有問題，這些問題可能損害其設(shè)備、設(shè)施、人員、其它物料和中間品或藥物活性成分
The contractor should supply to the contracted all necessary information so the latter can perform contracted operations according to the specifications of the intermediate or pharmaceutical input as well as any other legal requirements. The contractor should assure that the contracted be informed of any problems concerned the intermediate or the pharmaceutical input, service or assays, that put in hazardous its facilities, its equipments, its personnel, other materials and other intermediates or active pharmaceutical inputs.
 
17.8.       發(fā)包人應(yīng)保證承包人所發(fā)出的所有的中間品或藥物活性成分符合標(biāo)準(zhǔn)，并經(jīng)過授權(quán)人員放行
The contractor should guarantee that all intermediate or active pharmaceutical inputs delivered by the contracted, fulfills with its specifications and that the product are to be released by the authorized person.
 
17.9.       除了具有經(jīng)驗(yàn)和合格人員外，承包人應(yīng)具有圓滿完成發(fā)包人所要求服務(wù)的設(shè)施、設(shè)備和充分知識。生產(chǎn)合同只能有持有藥品/中間品生產(chǎn)許可和衛(wèi)生執(zhí)照的生產(chǎn)商履行。
The contracted should have facilities, equipments, and adequate knowledge, besides the experience and qualified personnel, for performing satisfactorily the service solicited by the contractor. The manufacturing contract only can be performed by manufacturers that hold Operating Authorization and Health License for the manufacturing activity of active pharmaceutical inputs and/or intermediates.  
 
17.10. 未經(jīng)發(fā)包人預(yù)先評估和批準(zhǔn)，承包人不得向第三方轉(zhuǎn)讓合同規(guī)定的服務(wù)。承包人和第三方簽訂的合同應(yīng)采用跟發(fā)包人簽訂的合同同樣的方式確定可使用的檢驗(yàn)和生產(chǎn)信息 
       The contracted can not transfer to third parties services foreseen in the contract, without the contractor previously evaluate and approve such contract modification. The firmed agreements between the contracted and third parties, should foresee availability of analytical information and information on manufacturing, of the same way that the firmed agreement between the contractor and contracted. 
 
17.11.     承包人不得從事對其生產(chǎn)和／或檢驗(yàn)的產(chǎn)品質(zhì)量有負(fù)面影響的任何活動(dòng)
The contracted should restrain from performing any activity that can affect adversely the quality of the manufactured product and/or analyzed by the contractor.
 
17.12.     合同應(yīng)規(guī)定雙方在生產(chǎn)和質(zhì)量控制方面的責(zé)任。合同的技術(shù)內(nèi)容由合格的技術(shù)人員確定，并經(jīng)雙方同意
The firmed contract between the contractor and the contracted should specify the responsibilities of each part about manufacturing and product control. Technical aspects of the contract should be composed by qualified persons necessarily having knowledge of production technology, analysis of quality control and GMP and should be agreed for both parts.    
 
17.13.     合同應(yīng)清楚規(guī)定采購、質(zhì)量檢驗(yàn)、物料放行、生產(chǎn)和控制方面的責(zé)任
The contract should describe clearly the responsibilities for acquisition, control assay and release of materials, for production and for performance of quality controls, including in-process controls, as well as the sampling responsibility and performance of analyses.
 
17.14.     合同應(yīng)規(guī)定生產(chǎn)記錄、檢驗(yàn)記錄和參考樣品應(yīng)由承包人保存。生產(chǎn)和檢驗(yàn)記錄的正本或復(fù)印件應(yīng)在生產(chǎn)和檢驗(yàn)所在地保存
The contract should establish that manufacturing records, analytical records and reference samples should be kept by the contractor, or be at its disposal. Manufacturing and analytical records, original or copies, should be disposal in the locality where the activity has place.
 
17.15.     合同應(yīng)規(guī)定中間品和／或藥物成分的發(fā)貨由承包人進(jìn)行，并保存記錄
The contract should establish that shipping of intermediate an/or pharmaceutical input are performed by contractor, and records kept.
 
17.16.     合同應(yīng)考慮在拒收原材料、中間品和藥物活性成分的情況下采取的行動(dòng)。
The contract should prevent actions to be adopted when there is rejection of raw materials, intermediates and active pharmaceutical inputs.