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

gaowenhua

委托方与受托方之间签订的合同应当详细规定各自的产品生产和控制职责，其中的技术性条款应当由具有制药技术、检验专业知识和熟悉本规范的主管人员拟订。

委托生产及检验的各项工作必须符合药品生产许可和药品注册的有关要求并经双方同意

gaowenhua

The contract signed between the client and the trustee shall specify in detail their respective product production and control responsibilities, and the technical terms shall be formulated by supervisory personnel with pharmaceutical technology, inspection expertise, and familiarity with this specification. All entrusted production and inspection work must comply with the relevant requirements of drug production license and drug registration, and be agreed upon by both parties

gaowenhua

合同应当详细规定质量受权人批准放行每批药品的调序，确保每批产品都已按照药品注册的要求完成生产和检验

gaowenhua

The contract should specify in detail the sequencing of each batch of drugs approved for release by the quality authorized person, ensuring that each batch of products has been produced and inspected in accordance with the requirements of drug registration

gaowenhua

合同应当规定由受托方保存的生产、检验和发运记录及 品，委托方应当能够随时调阅或检查;出现投诉、怀疑产品有质量缺陷或召时，委托方应当能够方便地查阅所有与评价产品质量相关的记录

gaowenhua

The contract shall specify the production, inspection, and shipping records and products to be kept by the entrusted party, and the principal shall be able to access or inspect them at any time; When there are complaints, doubts about product quality defects, or calls, the client should be able to easily access all records related to evaluating product quality

gaowenhua

合同应当明确规定委托方可以对受托方进行检查或现场质量审计

gaowenhua

The contract should clearly stipulate that the principal can inspect or conduct on-site quality audits on the entrusted party

gaowenhua

委托检验合同应当明确受托方有义务接受药品监督管理 部门检查

gaowenhua

The entrusted inspection contract should clearly state that the entrusted party has the obligation to accept inspection by the drug regulatory department