According to the website of the State Food and Drug Administration, the “Public Drug Production Quality Management Regulations†(hereinafter referred to as the “new drug GMPâ€), which has been revised for five years and publicly solicited for two comments, will be released on the 12th and will be implemented on March 1, 2011. .
"Pharmaceutical Production Quality Management Practice" is the basic principle for drug production and quality management. For the first time in China since 1988, GMP was enacted for more than 20 years. During the period, it was revised twice in 1992 and 1998. As of June 30, 2004, all APIs and preparations met the conditions of GMP. The goal of production.
It is reported that the new version of the GMP has a total of 14 chapters and 313 articles. Compared with the GMP revised in 1998, the number of articles has increased considerably. The new version of pharmaceutical GMP absorbs international advanced experience, combines China's national conditions, and implements the concept of quality risk management and drug production management in accordance with the principle of “pay equal attention to software and hardwareâ€. It also pays more attention to scientificity, emphasizes guidance and operability, and achieves World Health Organization consistency of pharmaceutical GMP.
The current pharmaceutical production enterprises in China present a pattern of multiple, small, scattered and low, with low production concentration and insufficient capacity for independent innovation. The implementation of the new version of pharmaceutical GMP is in line with the requirements of the country’s strategic emerging industries and the transformation of economic development methods. It will help promote the concentration of resources in the pharmaceutical industry to dominant enterprises, eliminate backward productive forces, help adjust the structure of pharmaceutical economy to promote industrial upgrading, help foster companies with international competitiveness, and accelerate the entry of pharmaceutical products into the international market.
The main features of the revised version of the new drug GMP are as follows:
The first is to strengthen the construction of pharmaceutical production quality management system and greatly increase the requirements for enterprise quality management software. The requirements for constructing a practical and effective quality management system have been refined, and the control and management of key links in drug production have been strengthened to promote the improvement of the quality management level of enterprises.
The second is to fully strengthen the quality requirements of employees. The terms and contents of the requirements for the quality of personnel engaged in pharmaceutical production quality management have been added to further clarify responsibilities. For example, the key personnel of the new pharmaceutical GMP clear pharmaceutical production enterprise include the qualifications and duties that must be fulfilled by the person in charge of the company, the person in charge of production management, the person in charge of quality management, and the quality attorney.
The third is to refine the document management regulations such as operating procedures, production records, and increase the guidance and operability.
The fourth is to further improve the drug safety protection measures. The concept of quality risk management was introduced. In the aspects of procurement of raw materials, changes in production processes, handling of deviations in operations, investigation and correction of discovery problems, and monitoring of post-marketing drug quality, supplier audits, change control, corrections, and prevention were added. Measures, product quality review, and other new systems and measures are used to manage and control the risks that may occur at each stage, and to actively prevent the occurrence of quality accidents. The environmental standards for the production of aseptic preparations have been increased, the on-line monitoring requirements for production environments have been increased, and the quality assurance level of sterile pharmaceuticals has been raised.
The new version of the drug GMP will be implemented on March 1, 2011. From March 1, 2011, the new (reform, expansion) workshops of new drug manufacturers and drug manufacturers should meet the requirements of the new drug GMP. The existing drug manufacturers will give a transition period of no more than five years, and according to the degree of risk of the product, the requirements of the new version of the drug GMP will be met in stages according to the category.
In addition, the State Food and Drug Administration requires drug manufacturers to formulate implementation plans and organize their implementation in light of their actual conditions. At the same time, drug regulatory authorities at all levels are required to strengthen the supervision, inspection and guidance of enterprises.
It is understood that the State Food and Drug Administration is in the process of formulating a new version of the implementation of pharmaceutical GMP, will be released soon.
"Pharmaceutical Production Quality Management Practice" is the basic principle for drug production and quality management. For the first time in China since 1988, GMP was enacted for more than 20 years. During the period, it was revised twice in 1992 and 1998. As of June 30, 2004, all APIs and preparations met the conditions of GMP. The goal of production.
It is reported that the new version of the GMP has a total of 14 chapters and 313 articles. Compared with the GMP revised in 1998, the number of articles has increased considerably. The new version of pharmaceutical GMP absorbs international advanced experience, combines China's national conditions, and implements the concept of quality risk management and drug production management in accordance with the principle of “pay equal attention to software and hardwareâ€. It also pays more attention to scientificity, emphasizes guidance and operability, and achieves World Health Organization consistency of pharmaceutical GMP.
The current pharmaceutical production enterprises in China present a pattern of multiple, small, scattered and low, with low production concentration and insufficient capacity for independent innovation. The implementation of the new version of pharmaceutical GMP is in line with the requirements of the country’s strategic emerging industries and the transformation of economic development methods. It will help promote the concentration of resources in the pharmaceutical industry to dominant enterprises, eliminate backward productive forces, help adjust the structure of pharmaceutical economy to promote industrial upgrading, help foster companies with international competitiveness, and accelerate the entry of pharmaceutical products into the international market.
The main features of the revised version of the new drug GMP are as follows:
The first is to strengthen the construction of pharmaceutical production quality management system and greatly increase the requirements for enterprise quality management software. The requirements for constructing a practical and effective quality management system have been refined, and the control and management of key links in drug production have been strengthened to promote the improvement of the quality management level of enterprises.
The second is to fully strengthen the quality requirements of employees. The terms and contents of the requirements for the quality of personnel engaged in pharmaceutical production quality management have been added to further clarify responsibilities. For example, the key personnel of the new pharmaceutical GMP clear pharmaceutical production enterprise include the qualifications and duties that must be fulfilled by the person in charge of the company, the person in charge of production management, the person in charge of quality management, and the quality attorney.
The third is to refine the document management regulations such as operating procedures, production records, and increase the guidance and operability.
The fourth is to further improve the drug safety protection measures. The concept of quality risk management was introduced. In the aspects of procurement of raw materials, changes in production processes, handling of deviations in operations, investigation and correction of discovery problems, and monitoring of post-marketing drug quality, supplier audits, change control, corrections, and prevention were added. Measures, product quality review, and other new systems and measures are used to manage and control the risks that may occur at each stage, and to actively prevent the occurrence of quality accidents. The environmental standards for the production of aseptic preparations have been increased, the on-line monitoring requirements for production environments have been increased, and the quality assurance level of sterile pharmaceuticals has been raised.
The new version of the drug GMP will be implemented on March 1, 2011. From March 1, 2011, the new (reform, expansion) workshops of new drug manufacturers and drug manufacturers should meet the requirements of the new drug GMP. The existing drug manufacturers will give a transition period of no more than five years, and according to the degree of risk of the product, the requirements of the new version of the drug GMP will be met in stages according to the category.
In addition, the State Food and Drug Administration requires drug manufacturers to formulate implementation plans and organize their implementation in light of their actual conditions. At the same time, drug regulatory authorities at all levels are required to strengthen the supervision, inspection and guidance of enterprises.
It is understood that the State Food and Drug Administration is in the process of formulating a new version of the implementation of pharmaceutical GMP, will be released soon.
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