基本公共卫生体检系统

1. GMP registration consultation is the embodiment of total quality management in the pharmaceutical industry& lt; Regulations for the Implementation of the Standardization Law of the People's Republic of China& gt; Article 18 stipulates that "standards and industrial standards are divided into mandatory standards and recommendatory standards". Drug standards are mandatory.

2、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、咨询。药品关系人命安危，因此药品咨询属于咨询，是属于一种强制性的咨询。

2. 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 consultation contents, it can be divided into quality consultation, system consultation and safety consultation. Drugs are related to the safety of human life, so drug consultation is a kind of safety consultation and a kind of mandatory consultation.

3、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。

3. GMP is an international GMP that embodies the new concept of quality management and quality assurance, and its characteristics are embodied in that it is a modified standard combined with iso9000~9004 standard series. While in foreign countries, some units implement the standards of FDA consultation in the United States, and in China, some units have passed the FDA consultation in the United States.

4、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。

4. The significance of international consultation 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. Take control measures for the quality of formula, raw materials, auxiliary materials, packaging materials, instruments and equipment and building materials.

5、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、优先受理新药药品申请。迄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。

5. The Drug Administration is a GMP consulting agency that independently conducts a third-party fair evaluation of drugs, its code is C12. Be responsible for giving priority to purchase, use and recommendation, and receiving new drug applications in international drug trade. For enterprises that have obtained consultation by the end of June 31, 1998, the drug regulatory authorities will no longer accept applications for new drug production.

6、GMP注册咨询是集软件、硬件、、卫生、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。

6. GMP registration consultation is a mandatory consultation integrating software, hardware, safety, health and environmental protection. Therefore, it must establish and operate a scientific and recognized international management system. A qualified second party (consulting agency) should be invited to participate in the overall planning and evaluation together with the enterprise's experts, so as to develop a quality management manual and operation instructions suitable for the enterprise's (including international standards, standards and industrial standards) specifications In the process of continuous correction of operation, it is a wise choice for every pharmaceutical company to apply for GMP consultation again.

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