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
MANUFACTURING CONTRACT AND/OR QUALITY CONTROL
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.
All involved in the contract should comply with the GMP/GLP. It should be given special consideration to prevention of cross-contamination and traceability.
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.
The firmed written contract should establish manufacturing procedures and/or analysis of intermediate or pharmaceutical input with all technical activities to both related.
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.
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.
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.
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.
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.
The contracted should restrain from performing any activity that can affect adversely the quality of the manufactured product and/or analyzed by the contractor.
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.
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.
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.
The contract should establish that shipping of intermediate an/or pharmaceutical input are performed by contractor, and records kept.
The contract should prevent actions to be adopted when there is rejection of raw materials, intermediates and active pharmaceutical inputs.