The subjects of "study on the quality of excipients for special injection in the evaluation of injection consistency" and "study on the production environment risk assessment and Countermeasures of raw and auxiliary packaging materials for sterile preparations" have been concluded

The conclusion meeting of the subject "quality research on excipients for special injection in consistency evaluation of injection" and "production environment risk assessment and Countermeasures Research on raw and auxiliary packaging materials for sterile preparations" of China pharmaceutical regulatory Research Association was held in Beijing According to the notice on the establishment of research project in 2019 issued by China pharmaceutical regulatory Research Institute, the Institute for the control of pharmaceutical excipients and packaging materials of CFDA (hereinafter referred to as the Institute for the control of excipients and packaging materials) undertook the research on the quality of excipients for special injection in the consistency evaluation of injection and the research on the production environment risk assessment and Countermeasures of raw and auxiliary packaging materials for sterile preparations Two topics At present, the research work of the project has been completed According to the conclusion requirements of China pharmaceutical regulatory Research Association, on December 3, 2019, the Institute of auxiliary materials and packaging materials organized and held the conclusion review meeting in Beijing 14 representatives from China food and drug International Exchange Center, national pharmacopoeia committee, national nano science center and China food and drug inspection and Research Institute attended the meeting Sun Huimin, director of the Institute of excipients and packaging materials, first made an opening speech, introducing the research background and significance of the two topics of "study on the quality of excipients for special injections in the consistency evaluation of injections" and "study on the production environment risk assessment and Countermeasures of raw and auxiliary packaging materials for sterile preparations" With the launch of the consistency evaluation of injections, carry out the research on the quality of excipients for special injections in traditional Chinese medicine Therefore, to improve the overall quality of pharmaceutical excipients for injection can provide technical support for the consistency evaluation of injections In the context of the review and approval of the relationship between the original excipients and preparations, to find out the key points and preventive measures for the production environment inspection of the original excipients for sterile preparations can help the manufacturers of the original excipients to reduce or avoid the impact on the quality of pharmaceutical preparations to the greatest extent, so as to protect the quality of pharmaceutical preparations Drug safety for the disabled The leaders of the two subjects reported in detail on the background, methods, contents, completion and achievements of the two subjects At last, through the expert's evaluation, the two subjects have completed the research content according to the requirements of the subject index, the research method design is scientific and reasonable, the research report content is substantial, the data is true, the conclusion is reasonable, and the two subjects have passed the conclusion Medical auxiliary materials and packaging materials inspection institute sprouted on December 6, 2019