Pharmaceutical companies organize generic consistency evaluation training
Release time:
2020-08-17
Pharmaceutical Company Organized Generic Drug Consistency Evaluation Training
News In order to publicize and learn relevant policies and technical requirements, # May 15 -17 , Pharmaceutical Company organized relevant personnel from Product Development Department, Quality Assurance Department and Peak Pharmaceutical Factory to conduct online training on generic drug injection consistency evaluation.
This training is conducted by the Drug Evaluation Center of the State Drug Administration as the technical guidance unit, and relevant evaluation experts have interpreted 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 Jinxi factory area and 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. (Lu Yating)
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