This newspaper (Reporter Chen Xiaoman) revised the new version of "Pharmaceutical Production Quality Management Practice" (GMP), which was revised five times and publicly solicited opinions for five times, recently issued by the Ministry of Health in the form of Decree No. 79. The new version of GMP will be implemented on March 1 this year.
According to the regulations, since March 1 this year, new (reform, expansion) workshops for new drug manufacturers and drug manufacturers should comply with the requirements of the new drug GMP. The current pharmaceutical production enterprises will be granted a transition period of no more than five years, and in accordance with the degree of product risk, the new version of the GMP requirements for drugs will be staged in stages.
Sun Xianze, director of the Department of Drug Safety Supervision and Administration of the State Food and Drug Administration, said that the main features of the new GMP include: strengthening the construction of pharmaceutical production quality management system, significantly increasing the requirements for the company's quality management software, and strengthening the key links in drug production. Control and management; comprehensively strengthen the quality requirements of employees, further clarify the responsibilities; detailed management regulations such as operating procedures and production records.
According to reports, the new version of GMP introduces the concept of quality risk management in terms of drug quality and safety protection. 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, new audits, change control, corrective and preventive measures, and product quality review analysis have been added. Systems and measures to manage and control the risks that may occur in various aspects, and actively prevent the occurrence of quality accidents. At the same time, the environmental standards for the production of aseptic preparations have been raised, the on-line monitoring requirements for the production environment have been increased, and the quality assurance level of sterile pharmaceuticals has been raised.
It is reported that the State Food and Drug Administration is currently working out the implementation of the new version of GMP, and will be released in the near future. At the same time, special requirements for drug production and management activities such as sterile drugs, biological products, and blood products will be separately formulated by the State Food and Drug Administration in the form of an appendix.
Drug GMP is the basic criterion for drug production and quality management. It has been more than 20 years since our country first promulgated GMP for drugs in 1988, during which GMP was revised twice in 1992 and 1998. On June 30, 2004, China achieved the goal of producing all raw material medicines and preparations in compliance with the conditions of GMP.
According to the regulations, since March 1 this year, new (reform, expansion) workshops for new drug manufacturers and drug manufacturers should comply with the requirements of the new drug GMP. The current pharmaceutical production enterprises will be granted a transition period of no more than five years, and in accordance with the degree of product risk, the new version of the GMP requirements for drugs will be staged in stages.
Sun Xianze, director of the Department of Drug Safety Supervision and Administration of the State Food and Drug Administration, said that the main features of the new GMP include: strengthening the construction of pharmaceutical production quality management system, significantly increasing the requirements for the company's quality management software, and strengthening the key links in drug production. Control and management; comprehensively strengthen the quality requirements of employees, further clarify the responsibilities; detailed management regulations such as operating procedures and production records.
According to reports, the new version of GMP introduces the concept of quality risk management in terms of drug quality and safety protection. 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, new audits, change control, corrective and preventive measures, and product quality review analysis have been added. Systems and measures to manage and control the risks that may occur in various aspects, and actively prevent the occurrence of quality accidents. At the same time, the environmental standards for the production of aseptic preparations have been raised, the on-line monitoring requirements for the production environment have been increased, and the quality assurance level of sterile pharmaceuticals has been raised.
It is reported that the State Food and Drug Administration is currently working out the implementation of the new version of GMP, and will be released in the near future. At the same time, special requirements for drug production and management activities such as sterile drugs, biological products, and blood products will be separately formulated by the State Food and Drug Administration in the form of an appendix.
Drug GMP is the basic criterion for drug production and quality management. It has been more than 20 years since our country first promulgated GMP for drugs in 1988, during which GMP was revised twice in 1992 and 1998. On June 30, 2004, China achieved the goal of producing all raw material medicines and preparations in compliance with the conditions of GMP.
Quantitative Pcr Instrument,Fast Real Time Pcr,Pcr System Thermal Cycler,Array Real Time Pcr System
Jiangsu Dinai Bioengineering Co.,ltd. , https://www.dinaipcr.com