委托生产与委托检验Commissioned production and commissioned inspection

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委托方应当确保物料和产品符合相应的质量标准。

委托加工的药品应是生产工艺成熟、质量稳定、疗效可靠、市场需要的 有中国药典或局颁正式标准及中国生物制品规程收载的制剂品种。委托方应确 保物料和产品符合相应的质量标准

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The client shall ensure that the materials and products meet the corresponding quality standards.The drugs entrusted for processing should be product varieties with mature production processes, stable quality, reliable therapeutic effects, and market needs that are included in the Chinese Pharmacopoeia or official standards issued by the bureau and the Chinese Biological Products Regulations.

The client shall ensure that the materials and products meet the corresponding quality standards

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受托方必须具备足够的厂房、设备、知识和经验以及人员，满足委托方所委托的生产或检验工作的要求

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The entrusted party must have sufficient factory buildings, equipment, knowledge and experience, as well as personnel, to meet the requirements of the production or inspection work entrusted by the entrusted party

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受托方必须具备足够的厂房、设备、知识和经验以及人员，满足委托方所委托的生产或检验工作的要求。

受托方应是持有与生产该药品的生产条件相适应的《药品生产质量管理规 范》认证证书的药品生产企业。受托方应当按照《药品生产质量管理规范》进 行生产，并按照规定保存所有受托生产文件和记录

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The trustee must have sufficient factory buildings, equipment, knowledge and experience, as well as personnel, to meet the requirements of the production or inspection work entrusted by the principal.

The entrusted party should be a pharmaceutical production enterprise that holds the "Good Manufacturing Practice for Drugs" certification certificate that is suitable for the production conditions of the drug. The entrusted party shall produce in accordance with the Good Manufacturing Practice for Drugs and keep all entrusted production documents and records in accordance with regulations

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受托方应当确保所收到委托方提供的物料、中间产品和待包装产品适用于预定用途

                               
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The trustee shall ensure that the materials, intermediate products, and packaged products received from the principal are suitable for the intended use

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受托方不得从事对委托生产或检验的产品质量有不利影响的活动

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The trustee shall ensure that the materials, intermediate products, and packaged products received from the principal are suitable for the intended use