Research and implementation of test magnification and technology transfer in the production process of chemical raw materials

On the test magnification and technology transfer in the production process of chemical raw materials

Research and implementation "notifications of the seminar

All relevant units:

At present, the development of chemical raw material is facing the challenge of cost-effective and efficient commercial production line. With the further implementation of GMP, more stringent and higher requirements for pharmaceutical production process and technology are put forward. Pilot scale enlargement is the only way of drug development to production, and it is also an effective measure to reduce the risk of industrialization. Therefore, the pilot magnification is very important, and its level represents the level of industrialization. When the pilot scale is magnified, there may be phenomena and problems that will not appear in the laboratory scale production, which is called magnification effect. The existence of amplification effect makes many mistakes that are easy to be implemented under small scale or easily corrected, sometimes become very complex, so we need further exploration and improvement.

And in the process of enterprise from R & D to production, or from analysis development to quality control. It is more or less involved in the problem of technology transfer, whether in outsourcing or technology transfer.

However, most companies do not pay much attention to this aspect, resulting in the final failure from subtle errors to sharp deterioration.

In order to help the pharmaceutical enterprises to seize the key technology, overcome and solve the scale-up technology of weak links, improve the level of research and development of pharmaceutical technology, to further enhance the innovation ability of pharmaceutical enterprises, enhance the level of quality and efficiency, saving the cost of R & D and production. After research, our unit is scheduled to hold the research and implementation of pilot scale enlargement and technology transfer of chemical raw material production process in Ji'nan on November 2017 24--26. The following matters are hereby notified as follows:

1. The time and place of the meeting:

Time: 24-26 November 2017 (report all day 24)

Location: Ji'nan city (to determine the location directly notify the applicants)

Two. The main topics of the conference

See Annex I (schedule) for details

Three. Participants

The pharmaceutical companies engaged in product development, production technology research, quality assurance and other related research and development, technology and management personnel; to provide optimum design and technical services unit for pharmaceutical enterprises; the relevant professional colleges and universities research institutes and medical institutions; the pharmaceutical industry planning and management departments and the pharmaceutical chemical industry park, investment and consulting units; related products and equipment and inst