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产品质量咨询的种类按质量咨询的责任不同，可分为自我咨询使用方咨询第三方咨询。按咨询内容不同，可分为质量咨询体系咨询安全咨询。药品关系人命安危，因此药品咨询属于安全咨询，是属于一种强制性的咨询。
The types of product quality consultation can be divided into self-consultation, user consultation and third-party consultation according to the different responsibilities of quality consultation. According to different consulting contents, it can be divided into quality consulting system consulting and safety consulting. Drugs are related to the safety of human life, so drug consultation is a kind of mandatory consultation.
GMP是一部体现质量管理和质量保证新概念的国际GMP，其特点体现在它是结合 iso9000~9004标准系列修改而成的标准。而在国外有些执行着美国FDA咨询的标准，我国也有些单位通过了美国FDA咨询。
GMP is an international GMP that embodies the new concepts of quality management and quality assurance. Its characteristics are reflected in the fact that it is a standard modified by combining the series of iso9000~9004 standards. In foreign countries, some units implement the standards of FDA consultation in the United States, and some units in China have passed the FDA consultation in the United States.
国际咨询的意义本身就是不仅要加强药厂内部诸多质量因素的过程控制，也要对药厂外部关键质量因素有所控制。如配方原料辅料包装材料仪器设备以及建筑材料的质量采取控制措施。
The significance of international consultation itself is not only to strengthen the process control of many quality factors inside the pharmaceutical factory, but also to control the key quality factors outside the pharmaceutical factory. For example, control measures shall be taken for the quality of formula raw materials, auxiliary materials, packaging materials, instruments and equipment, and construction materials.
药品监督管理局是代表对药品独立地进行第三方公正评价的GMP咨询机构，其代码C12。负责国际药品贸易中优先采购使用推荐优先受理新药药品申请。迄至1998年6月31日末取得咨询的企业，药品监督管理部门将不再受理新药生产的申请。
The Drug Administration is a GMP consulting agency representing the independent and impartial evaluation of drugs by a third party. Its code is C12. Be responsible for the priority of purchasing and recommending new drug applications in international drug trade. As of the end of June 31, 1998, the drug supervision and administration department will no longer accept the application for new drug production.
GMP注册咨询是集软件硬件安全卫生环保于一身的强制性咨询，那么它就必须建立和运行着科学的公认的国际管理体系，要请有资历的第二方(咨询机构)汇同本企业专家进行整体策划评估，制订出适合本企业 (含国际标准标准行业标准) 规范的质量管理手册及作业指导书，在学习培训运转的不断修正过程中，再来申请GMP咨询才是每个药业人明智的选择。
GMP registration consultation is a mandatory consultation that integrates the safety, health and environmental protection of software and hardware, so it must establish and operate a scientific and recognized international management system. A qualified second party (consulting agency) should be invited to conduct an overall planning and evaluation with the enterprise's experts, and develop a quality management manual and operation instructions that are suitable for the enterprise's (including international standards, industry standards) specifications. In the process of continuous revision of the learning and training operation, It is a wise choice for every pharmaceutical industry to apply for GMP consultation.
有了GMP注册咨询上面的小总结，希望对广大客户有所帮助，如果有什么不理解的或者寻求帮助的请点击我们的网站：https://www.fmkgmp.com或者来电咨询，我们会尽全力为您解决
With the summary above of GMP registration consultation, I hope it can help our customers. If you have any questions or need help, please click our website: https://www.fmkgmp.com Or call for consultation, and we will do our best to solve it for you