gmp certification means:
1, GMP certification is the embodiment of total quality management in the pharmaceutical industry, << the Chinese people **** and the implementation of the National Standardization Law Regulations >> 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 quality management and quality assurance of new concepts of international GMP, which is characterized by the 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 over the 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.
Expanded:
Features of the new version of the GMP:
The new version of the GMP provisions are more specific, more instructive and more operable; in the production conditions and management system The provisions in the production conditions and management system are more comprehensive and specific, and further ensure the safety, stability and uniformity of drug quality from the production link.
The new GMP is characterized by enhanced software requirements.
One is to strengthen the construction of the drug production quality management system, significantly increasing the quality of the enterprise management software requirements. Refine the requirements for the construction of practical, effective quality management system to strengthen the control and management of key aspects of drug production, in order to promote the improvement of the level of enterprise quality management.
The second is to comprehensively strengthen the quality requirements of practitioners. Increased quality management personnel engaged in the production of drugs quality requirements of the provisions and content, to further clarify the responsibilities. For example, the new version of the drug GMP clear drug production enterprises, including the key personnel, including the head of the enterprise, production management, quality management, quality of the person in charge of authorization must have the qualifications and duties to be performed.
Thirdly, the operating procedures, production records and other document management provisions have been refined to increase guidance and operability.
Baidu Encyclopedia-GMP Certification