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Pharmaceutical company employees to participate in drug registration knowledge training

Release time:

2021-03-01

News from our newspaper 2# March 5, Pharmaceutical Company organized employees to participate in online training on the work requirements related to on-site verification of drug registration application in 2021 .

This training is the first training organized by the Food and Drug Examination and Inspection Center of the State Drug Administration for registered users of the window of drug registration applicants. The window of drug registration applicants is a brand-new application platform for applicants created by the State Food and Drug Administration Verification Center to speed up the informatization construction of drug and medical device review and approval, gradually realize the electronic submission and review and approval of various registration applications, and to ensure the smooth implementation of the Measures for the Administration of Drug Registration, focusing on

"serving drug registration applicants " and combining with the on-site inspection requirements of the center. At present, the window of drug registration applicants has integrated three types of inspections: drug registration and production site verification, chemical generic drug injection registration and production site verification, and consistency evaluation and development / production site verification. Other types of inspections will also be gradually integrated and continuously updated to the platform in the future.

In order to better grasp the functions and usage methods of

"window of drug registration applicants " , comprehensively and systematically understand the procedures and requirements of online submission of information before on-site verification of "drug registration application " , and improve the quality and efficiency of drug registration verification, various departments of the pharmaceutical company actively organized relevant personnel to participate in the training, for the future drug registration, on-site verification and other work to lay a good foundation. (Lv Yating

Wang Junyang)

More information

Peak natural products among the top 20 scientific and technological innovation in TEDA

A few days ago, Tianjin Jianfeng Natural products Research and Development Co., Ltd. stood out among nearly 35000 enterprises in Tianjin Development Zone and won the honor of "Top 20 Scientific and technological Innovation Enterprises of 2015. The selection criteria for the top 20 scientific and technological innovation enterprises in Tianjin Economic and Technological Development Zone mainly include: they have won science and technology awards or patent awards in 2015, as well as other awards above the provincial level; they have obtained the qualification certification or approval of research and development institutions above the provincial level; in 2015, the number of invention and utility model patent applications and authorizations was large, totaling more than 15; in 2015, they were supported by national or Tianjin key science and technology plans; scientific research achievements have made significant progress and technology. According to the above standards, Jianfeng Natural Products Company has not only won the second prize of Tianjin Science and Technology Innovation Project Award for the achievements of "Tianjin Plant Waste Reutilization Technology Engineering Center Construction", but also completed the process research of grape seed extract and ginsenoside to pesticide residues, and formulated the international business standard of grape seed extract (grape seed oligomeric proanthocyanidins). In order to better carry out the pilot experiment, large-scale technical transformation was carried out on the second workshop, and the process optimization of extracting anthocyanins from blueberries has been carried out. At the same time, the main business income, operating profit, tax revenue and other economic indicators of peak natural products company in 2015 have increased significantly year-on-year. Relying on the advantages of excellent quality, good efficiency, great contribution, safety and environmental protection, and good social responsibility, Jianfeng Natural Products Company successfully passed the review and became one of the "Top 20 Scientific and Technological Innovation Enterprises in 2015" in Tianjin Development Zone. (

2020

07-31

Peak natural products among the top 20 scientific and technological innovation in TEDA

2020

07-30

Peak pharmaceutical "enterprise information construction project" through the acceptance

The "Enterprise Informatization Construction Project" of Jianfeng Pharmaceutical Company was included in the list of key projects of "Integration of Industrialization and Industrialization" (high-level and in-depth combination of informatization and industrialization) in Jinhua City in 2015, and successfully passed the on-site acceptance of the expert group on the morning of May 18. The main contents of the "enterprise information construction project" of the pharmaceutical company include: the tank farm control system, which solves the problem of closed metering and transportation of organic solvents between the tank farm and the production area, can automatically realize the terminal metering setting, and effectively ensure the safety and environmental protection requirements of the tank farm operation; The air conditioning automatic control system realizes the control of the temperature, humidity and room pressure difference in the air conditioning area through the PLC digital-to-analog conversion of the upper computer and lower computer and the terminal actuator regulator, ensure the cleanliness requirements of the production area environment; The online particle monitoring software system automatically adjusts to the standard flow through the upper computer, vacuum system, laser sensor and isodynamic sampling probe, etc. through the flow detector device and key orifice plate inside each sensor, monitors the temperature, humidity, particles, planktonian bacteria, room pressure difference, etc., implements dynamic management, and realizes visual monitoring of the production process environment. MRP production management system, it makes it easier for the warehouse, workshop, and management personnel to obtain information about the flow of materials in the production process, the implementation of production plans, and product inventory. During the on-site acceptance on the 18th, the acceptance team composed of the Information Department of the Municipal Economic and Information Commission, the Economic and Development Bureau of the Development Zone, the Municipal Information Promotion Association and professors of Zhejiang Normal University checked the contracts of each system software, purchase and transfer records, training records, and problem records in project implementation,

2020

07-31

Peak natural products among the top 20 scientific and technological innovation in TEDA

2020

07-31

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