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

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为确保委托生产产品的质量和委托检验的准确性和可靠性，委托方和受托方必须签订书面合同，明确规定各方责任、委托生产或委托检验的内容及相关的技术事项

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To ensure the quality of the commissioned production products and the accuracy and reliability of the commissioned inspection, the commissioning party and the entrusted party must sign a written contract that clearly defines the responsibilities of each party, the content of commissioned production or inspection, and related technical matters

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委托生产中的受托方应具备的资质:受托方应为药品生产企业，具有药品生产许可证、药品CMP认证证书，经许可和认证的生产范围中应包括受托生产 的剂型或品种

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Qualifications that the entrusted party in entrusted production should possess: The entrusted party should be a pharmaceutical production enterprise with a pharmaceutical production license and a pharmaceutical CMP certification certificate. The licensed and certified production scope should include the dosage forms or varieties entrusted for production

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委托方应当向受托方提供所有必要的资料，以使受托方能够按照药品注册和其他法定要求正确实施所委托的操作

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The principal shall provide the trustee with all necessary information to enable the trustee to correctly carry out the entrusted operations in accordance with drug registration and other legal requirements

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委托方应当使受托方充分了解与产品或操作相关的各种问题，包括产品操作对受托方的环境、厂房、设备、人员及其他物料或产品可能造成的危害

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The principal shall make the trustee fully aware of various issues related to the product or operation, including the potential harm that the product operation may cause to the trustee's environment, factory buildings, equipment, personnel, and other materials or products

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根据药品生产监督管理办法规定:

委托方负责委托生产药品的质量和销售。委托方应当对受托方生产全过程进行指导和监督

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According to the Measures for the Supervision and Administration of Drug Production, the commissioning party is responsible for the quality and sales of the commissioned drugs. The entrusting party shall provide guidance and supervision to the entire production process of the entrusted party