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Pharmaceutical Company Sends Staff to Participate in Simulation Filling Technology Exchange

Release time:

2020-07-22

Pharmaceutical Company sent personnel to participate in the exchange of simulated filling technology

News 4# July 26 , Merck's medium simulated filling and 2020 Pharmacopoeia Law Update Exchange Meeting were held in Hangzhou. As the production base of sterile bulk drugs and sterile preparations of Jianfeng Pharmaceutical Company, Jinxi Factory of Jianfeng Pharmaceutical Company sent personnel to participate in the sharing meeting, learn about medium simulation filling and microbial content of Chinese Pharmacopoeia 2020 .

In this training, relevant staff of Merck Company, special experts of China Pharmaceutical Quality Association and Zhejiang Institute of Drug Inspection respectively shared and introduced the contents of medium simulation filling technology, problems involved in the process, and update of microbial detection content of Chinese Pharmacopoeia 2020 . At the same time, Merck also demonstrated equipment and projects such as microbial detection medium, microbial membrane filtration testing equipment, sterile testing and environmental monitoring systems in the training center.

Through technical exchanges, the trainees learned in advance about the microbial content to be updated in the new pharmacopoeia, and also had a deeper understanding of the operation of equipment such as buoyant bacteria samplers and culture media needed for daily production. (Lin Jianping)

Training Feeling

4 January 26 , another colleague and I had the honor to participate in Merck Medium Simulation Filling and 2020 Pharmacopoeia Regulation Update Exchange.

The keynote speakers of this meeting include Dunxin, a distinguished expert from China Medical Quality Management Association, Zheng Xiaoling, deputy director pharmacist of Zhejiang Food and Drug Inspection Institute, and Li Feng, Asia Pacific Regulatory Manager of Moker Life Sciences. Teacher Dunxin gave a lecture on the related topics of aseptic process simulation filling test, starting from three aspects: the necessity of simulation filling, the problems that often occur in audit inspection and the treatment of positive results. He mentioned that in the audit and inspection process he experienced in his career, he encountered many principled issues such as the authenticity of simulated filling, the antibacterial properties of simulated media, and whether the whole process of simulated filling is representative. As QA , I have participated in the aseptic process simulation filling test in the powder injection workshop for many times. In combination with what Mr. Dunxin said, I recalled the simulation filling test I participated in and found that our aseptic process simulation filling scheme is relatively complete, the design of interference factors is relatively comprehensive, and the implementation is ideal.

Li Feng and Zheng Xiaoling respectively introduced the general situation of Chinese Pharmacopoeia, the update of microbial detection content of 2020 edition, and the project progress of microbial rapid detection methods to the participants. They answered in detail the problems of microbiological testing encountered by the trainees in their work, and discussed the common problems of microbiological testing. Although microbiological examination is not my job, as a student majoring in bioengineering, I am still very interested in the current development of biotechnology. The content of this course makes me feel very useful.

In this short period of one day, I learned about the current development of the pharmaceutical industry in microbial testing, and also learned the relevant theoretical knowledge of aseptic process simulation filling technology. I discussed the problems encountered in my work with experienced experts and met several colleagues with outstanding abilities. This trip is really worth it! (lisa liao)

More information

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