Chinese
Registration of medicinal raw materials as early as the file system should try
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DMF is the essence of the agents involved in the production of many aspects of the source as a whole, will expand to monitor the quality of the entire chain of drug production, the preparation is not only concerned about the internal quality manufacturers, but also to learn more about the raw materials and so the whole production process and quality. DMF (DrugsMasterFile) "registration of medicinal raw materials and documents" management system is in Europe, America, Japan and other developed countries and regions regulate the pharmaceutical market, to enhance a pharmaceutical production, quality and regulatory management. The model calls for active pharmaceutical ingredients, materials, direct contact with drug packaging materials and containers, chemical intermediates manufacturer, in accordance with the provisions of the information requirements and procedures, its production processes, quality standards, process parameters and quality indicators, and all other technical information voluntarily submitted to the legal authority for the competent authorities, customers, etc. in the pharmaceutical registration, production, and supervision and the process technology used document management system. Developed countries in the implementation of DMF, in regulating the pharmaceutical raw materials, auxiliary materials, packaging materials and chemical intermediates in the quality of supervision, the Pharmaceutical Affairs departments and enterprises to reduce duplication of reporting, repeated review of the workload, the advantages of its operating system has been fully sure. Should apply their knowledge DMF file management system first, to establish their own production company, the second is to make relevant information available to the agent business. Files generally involve the establishment of public and private two parts. Non-public part of the general Corporation was the content, process parameters such as confidentiality, to prevent core secrets leaked by the Government to give a DMF number for confidential management. For confidential documents, the Government does not immediately review, when the production enterprises in the preparation of its declaration to the registered manufacturers to use materials, should provide the appropriate accessories manufacturers DMF number, this time before the relevant agencies in the review preparations at the same time its review. DMF by manufacturer (or supplier) free filing system, the data includes information in the manufacturing, processing, packaging, storage, wholesale drugs used in the activities of production facilities, process, quality control and the use of raw materials, packaging materials and other details information. Customers who apply for the use of the raw materials for one or more clinical research applications (IND), innovative drug applications (NDA), Abbreviated New Drug Application (ANDA), export of application or the application of the above amendments and additions, the DMF is is activated by the country's legal authority record review; such as prescription drugs are used as ingredients, then follow up the official certification or on-site audit. Upstream and downstream regulatory authorities and enterprises through inter-checks and balances, which will declare the registration of drugs as much as possible to simplify procedures, improve the efficiency of the review; but also for the preparation of a comprehensive quality control of pharmaceutical safety and security of a reliable network to maximize the effect of . DMF system to build a pharmaceutical industry chain information exchange platform. The system involves three main - producers of raw materials, raw materials users and regulators. Among them, the quality of raw materials producers for the materials and the main responsibility for the authenticity of the record information; raw materials for the users of the drug manufacturers to ensure drug quality and the procurement of the main responsibilities of qualified quality materials; regulators quickly and efficiently through the system and access to drugs trial Review the information, reduce communication costs, to ensure that information is reliable. Conducive to comprehensive supervision DMF is the essence of many involving Yuantou agent production areas as a whole, will oversee expand to the entire pharmaceutical production quality 链条, so Zhiji manufacturers not only concerned about their internal quality, but also to learn more about the entire production of its raw materials, etc. process and quality. Implementation of DMF, is conducive to preparation of the review, but also to review the information economy, reduce duplication of reporting; the same time, also help to strengthen the regulation of pharmaceutical starting material, from the source to ensure quality and safety of drugs, will ultimately enhance the production of enterprises to truly become the main responsibility for quality, in particular, is to strengthen the preparation of raw materials production enterprises audit responsibility and self-discipline, so that drug manufacturers really take the first responsibility to ensure drug safety liability.