Henan Provincial Bureau actively promotes the implementation of newly revised GMP

Recently, the food and Drug Administration of Henan Province announced the list of 125 GMP certification inspectors to be reappointed this year, and organized some inspectors to hold a symposium to solicit opinions and suggestions on further promoting the implementation of the newly revised GMP While making suggestions and suggestions in combination with the actual work of certification and inspection, participants said that the cadre contact point system established by Henan Provincial Bureau this year has played an obvious role in promoting the implementation of the newly revised GMP and should continue to adhere to and improve In March this year, based on the investigation and analysis of the situation of GMP certification, Henan Provincial Bureau decided to establish and implement the newly revised GMP cadre contact point system to further supervise, guide and help enterprises speed up the pace of certification The Bureau divides the drug manufacturing enterprises in 18 cities under the jurisdiction of the whole province into 6 areas The drug safety supervision office and 6 department level cadres of the drug evaluation and certification center contact the enterprises in 3 cities respectively, and organize experts to train the relevant personnel of the enterprises in stages and batches At present, 970 people from 251 enterprises have been trained, a unified QQ group has been established, and a platform for exchange, sharing and interaction of professional and technical information for the implementation of the newly revised GMP has been established Every quarter, the contact cadres went deep into the enterprises they contacted, repeatedly publicized the national policies and measures on accelerating the implementation of the new revised GMP, corrected the misconceptions of some enterprises, such as "new workshops must be built for the implementation of the new revised GMP or the transformation of production suspension", "only the purchase of the most advanced flow line can pass the certification", and made the enterprises deeply understand the essence of the new revised GMP It is to establish a sound quality management system and improve the level of drug quality and safety assurance In addition, contact cadres also organize experts and technical personnel to guide and help enterprises to solve specific problems in the implementation process For example, technical guidance is given to the workshop transformation of high-risk aseptic preparation production enterprises, which clarifies the fuzzy concepts of the layout design, dynamic monitoring, equipment connection, etc of the clean area of the enterprise; in the aspect of the enterprise's relocation of the new workshop, guidance is given to the scientific arrangement of the project progress, so as to ensure that sufficient time is reserved for the supplementary application for the change of production address registration Specific and detailed guidance has effectively improved the scientific level and comprehensive benefits of the implementation of the new GMP revision The Bureau has also formulated detailed rules for the implementation of the assessment of GMP certification inspectors, and carried out dynamic assessment management and centralized training for inspectors from four aspects: work style, business ability, dispatching attendance and integrity discipline, so as to improve the professional level and performance ability of the inspectors At the same time, strict certification and inspection discipline, unified certification and inspection standards, strengthened follow-up flight inspection, formulated inspection plan based on risk control according to the characteristics of enterprise production dosage forms and varieties, improved the pertinence and effectiveness of on-site inspection, and ensured that the newly revised GMP certification and inspection work was scientific, fair, strict, standardized and unified A series of measures combining optimized service and strengthened supervision have fully mobilized the enthusiasm and creativity of enterprises to further improve the drug quality management system, and also enhanced the main responsibility consciousness of enterprises Up to now, 60 pharmaceutical manufacturers in Henan Province have passed the newly revised GMP certification and obtained 73 GMP certification certificates Among them, 14 sterile drug manufacturers have passed the certification, 21 certificates have been issued; 46 non sterile drug manufacturers have passed the certification, 52 certificates have been issued, and the overall pass rate is 20.7% With the orderly implementation of the newly revised GMP and the steady acceleration of certification, Henan pharmaceutical industry has entered the fast lane of industrial structure adjustment and optimization.