RULES OF BRAZILS CONTRACT AND/OR QUALITY CONTROL OF MEDICINE MANUFACTURING 第17条. 生产合同和／或质量控制 MANUFACTURING CONTRACT AND/OR QUALITY CONTROL 17.1. 生产和或检验合同应经双方协商订立，避免出现造成不合格程序、产品或检验错误。合同应由RULES OF BRAZIL’S CONTRACT AND/OR QUALITY CONTROL
OF MEDICINE MANUFACTURING
第17条. 生产合同和／或质量控制
MANUFACTURING CONTRACT AND/OR QUALITY CONTROL
17.1. 生产和或检验合同应经双方协商订立，避免出现造成不合格程序、产品或检验错误。合同应由双方采用书面形式详细确定GMP/GLP方面的责任，各个部分的明确特点包括质量措施,和与产品放行和检验报告签发相关的方面
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. 合同的所有内容应符合GMP/GLP。应特别考虑防止交叉污染,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. 除非经双方同意，不得变更工艺、设备、检验方法、标准和其它合同要求
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. 书面合同应规定中间品和／或药物成分的生产程序和/或检验方法
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. 合同应规定发包人可审核承包人设施，以便确认是否符合
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. 对于检验合同，应有经过授权的人员最终批准中间品和药物成分的放行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. 发包人向承包人提供所有必要的信息，使承包人按照中间品和药物成分的标准进行操作。发包人应保证承包人了解有关中间品、药物成分、服务或检验的所有问题，这些问题可能损害其设备、设施、人员、其它物料和中间品或药物活性成分
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. 发包人应保证承包人所发出的所有的中间品或药物活性成分符合标准，并经过授权人员放行
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. 除了具有经验和合格人员外，承包人应具有圆满完成发包人所要求服务的设施、设备和充分知识。生产合同只能有持有药品/中间品生产许可和卫生执照的生产商履行。
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. 未经发包人预先评估和批准，承包人不得向第三方转让合同规定的服务。承包人和第三方签订的合同应采用跟发包人签订的合同同样的方式确定可使用的检验和生产信息
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. 承包人不得从事对其生产和／或检验的产品质量有负面影响的任何活动
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. 合同应规定双方在生产和质量控制方面的责任。合同的技术内容由合格的技术人员确定，并经双方同意
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. 合同应清楚规定采购、质量检验、物料放行、生产和控制方面的责任
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. 合同应规定生产记录、检验记录和参考样品应由承包人保存。生产和检验记录的正本或复印件应在生产和检验所在地保存
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. 合同应规定中间品和／或药物成分的发货由承包人进行，并保存记录
The contract should establish that shipping of intermediate an/or pharmaceutical input are performed by contractor, and records kept.
17.16. 合同应考虑在拒收原材料、中间品和药物活性成分的情况下采取的行动。
The contract should prevent actions to be adopted when there is rejection of raw materials, intermediates and active pharmaceutical inputs.
