1, GMP certification is the embodiment of total quality management in the pharmaceutical industry,> Article 18 states: "National standards, industry standards are divided into mandatory standards and recommended standards. And pharmaceutical standards are mandatory standards.
2, the type of product quality certification according to the different responsibilities of quality certification can be divided into self-certification, user certification, third-party certification. According to the different content of the certification can be divided into quality certification, system certification, safety certification. Drugs related to human life and safety, so drug certification is a safety certification, is a mandatory certification.
3, GMP is an embodiment of the new concept of quality management and quality assurance of the international GMP, which is characterized by its combination of ISO9000 ~ 9004 standard series of modified standards. And in some foreign countries to implement the standards of the U.S. FDA certification, China also has some units through the U.S. FDA certification.
4, the significance of the international certification itself is not only to strengthen the process control of many quality factors within the pharmaceutical plant, but also to have control of key quality factors outside the pharmaceutical plant. Such as formulations, raw materials, excipients, packaging materials, instruments and equipment, as well as the quality of construction materials to take control measures.
5, the State Drug Administration is on behalf of the State of the drugs independently for third-party impartial evaluation of the GMP certification body, its code C12. responsible for the international drug trade in priority purchasing, the use of the recommended priority to accept applications for new drugs and medicines. As of June 31, 1998 the end of the certified enterprises, drug supervision and management departments will no longer accept applications for the production of new drugs.
6, GMP certification is a set of software, hardware, safety, health, environmental protection in one of the mandatory certification, then it is necessary to establish and operate a scientific, recognized international management system, we should ask the second party (consulting agency) with the qualifications of the experts in the enterprise for the overall planning, assessment, the development of a suitable for the enterprise (including international standards, national standards, industry standards) norms of quality control manuals and operating instructions, in the study of the quality management of the enterprise (including international standards, national standards, industry standards). Manual and operating instructions, in the learning, training, operation of the continuous correction process, and then apply for GMP certification is a wise choice for each pharmaceutical people.