Read the technical points of the study on the compatibleness of plastic component systems used in injection production.

On October 21, 2020, the official website of the Drug Review Center of the State Drug Administration issued the Technical Guide for the Study of the Compatibleness of Plastic Components used in the Production of Chemical Injections (Trial), which was implemented on October 21, 2020, as of the date of publication, and is designed to regulate the evaluation of the quality and efficacy of chemical injections. The production of plastic components system compatible research, the formal implementation of the standard will fill the domestic chemical injection production of plastic components system compatible research a big gap, to help further improve the quality of domestic pharmaceutical products, this paper combed the chemical injection production of plastic components system compatible research pain points and bright spots, for pharmaceutical companies to carry out chemical injection production of plastic components system compatible research to provide reference.
, plastic component system compatible research pain point October 21, 2020, CDE issued "on the injection consistency evaluation of supplementary information related matters notice", clear injection consistency, no secondary supplement! Substantive defects, direct non-approval, the reason is that since the chemical generic injection consistency evaluation work has been carried out, some injection consistency evaluation varieties registration and declaration data defects are obvious, and the relevant guidelines require a large gap, need to supplement a large number of new research work.
pharmaceutical companies have received corrective notices requesting research on the compatibleness of chemical plastic component systems.
Really detonated the domestic industry began to pay attention to the plastic component system compatible research is the injection consistency evaluation officially opened, May 14, 2020, the State Drug Administration (NMPA) officially released the "chemical injection imitation drug quality and efficacy consistency evaluation technical requirements", the official announcement of the consistency evaluation of injections officially opened, requiring filter compatible research according to the production process.
According to the characteristics of the solution and production process for direct contact with silicone tubes and other liquid containers of compatible research, in order to cooperate with the chemical injection imitation drug quality and efficacy consistency evaluation work, standardize the chemical plastic component system compatible research, CDE since June 2019 launched the "chemical injection production of plastic components system compatible research technical guide" to start the preliminary research and data translation, after a number of expert meetings to discuss and form a draft for comments. June online for comments for one month (as of July 02, 2020);
leaching in liquids and eventually transfer to the final product may affect product quality and/or patient safety.
With the progress of science and technology and technological development, pharmaceutical regulatory departments and organizations in various countries pay more and more attention to the impact of plastic component systems used in the injection production process on drug quality, but before the domestic has not yet issued the relevant technical requirements of plastic components systems, CDE according to the current technical requirements of chemical injections, drawing on relevant guidelines and standards at home and abroad, mainly drawing on the usP PF 665/1665 core ideas and overall ideas, combined with domestic reality, not copy USP, drafting The first "Chemical plastic component system compatible research technical guide (trial)", foreign relevant guidelines and standards list combed as follows: Third, plastic components system compatible research highlights to see the highlights 1 - the scope of application of clear bright spots 2 - component system selection principle highlights 3 - risk assessment references: the author's introduction: drips, male, biomedical senior engineers, based on the biopharmaceutical industry quality management, focusing on the biopharmaceutical industry.
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