Pharmaceutical companies organize generic consistency evaluation training


Release time:

2020-08-04

in order to do a good job in publicizing and studying relevant policies and technical requirements,7Month15Day-17On the same day, the pharmaceutical company organized the relevant personnel of the product development department, the quality assurance department and the peak pharmaceutical factory to conduct online training on the consistency evaluation of generic injections.

The training was conducted by the Drug Evaluation Center of the State Drug Administration as the technical guidance unit, and relevant evaluation experts explained the consistency evaluation of chemical generic drugs in detail, taking into account the "Drug Registration Management Measures" and supporting documents, this paper systematically introduces the work overview, technical requirements, guiding principles, start-up inspection, reference preparation application data, packaging material compatibility, impurity research, raw material related review and other related requirements of chemical generic drug injection consistency evaluation.

In order to facilitate colleagues from various departments to participate in the training, the pharmaceutical company has set up a training venue in the Jinxi factory area and the Qiubin factory area respectively. Participants actively participated in online communication, raised questions for their respective positions and received professional responses from experts. After three days of training, the trainees have a deeper understanding of the consistency evaluation of generic drug injections, which has laid a good foundation for the consistency evaluation work in this position.