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On October 21, 2020, the official website of the Drug Review Center of the State Drug Administration issued the Technical Guidelines for the Study of Compatibleity of Plastic Component Systems used in the Production of Chemical Injections (Trial), which will be implemented from October 21, 2020 on the date of publication, and regulate the plastics used in the production of chemical injections in line with the evaluation of the quality and efficacy of chemical injections. Component system compatible research, the formal implementation of the standard will fill a gap in the domestic chemical injection production of plastic component system compatible research, to help further improve the quality of domestic pharmaceutical products, this paper combed the chemical injection production of plastic component system compatible research pain points and highlights, for pharmaceutical companies to carry out chemical injection production of plastic component 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 supplementation! 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 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 the 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 many expert meetings to discuss, 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 production process of injections on the quality of drugs, 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 using USP, drafted the first domestic chemical plastics Technical Guide to Component System Compatibleity Research (Trial) And the list of relevant foreign guidelines and standards is as follows: (1) Chemical injection generics quality and efficacy consistency evaluation technology requires systematic compatible research of plastic components (No. 2 of 2020 of the Drug Review Center of the State Drug Administration) (2) Technical Guidelines for chemical and elastomer seal compatible research (trial) (National Drug Administration Circular No. 14, 2018) (3) Technical Guidelines for the Study of Compatibity between Chemical Injections and Plastic Packaging Materials (Trial) (National Food and Drug Administration Note No. 267) (4) Research on The Theory and Practice of Drug and Packaging Compatibleity in Plastic Component Systems Chemical Industry Press Plastic Component System Compatible Study 2019 (5) YBB00012003-2015 Cytotoxicity Inspection Act (6) USP PF-lt;665-Plastic Materials, Components, And Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products. (7) USP PF-lt;1665;Characterization of Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Pharmaceutical Products and Biopharmaceutical Drug Substances and Products. (8) USP slt;87, 88-Gt; Biological Reactivity Tests (9) USP-lt;381, 661, 1661, 1663, 1664-gt; (10) EP 3.1.9. Silicone Elastomer for Closures and Tubing. (11) Sterilization D-Ed d'Liquids. PDA Technical Report 26. Journal of Pharmaceutical Science and Technology 2008, 62. (12) ICH Q3D Guideline for Elemental Impurities. (13) Perspectives on the PQRI Extractables and Leachables 'Safety Thresholds and Best Practices' Recommendations for Inhalation Drug Products. PDA Journal of Pharmaceutical Science and Technology 2013, 67 413-429. (14) The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Products (PODP). PDA Journal of Pharmaceutical Science and Technology 2013, 67 430-447. Third, the plastic component system compatible research highlights to see the first bright spot 1 - the scope of application is clear bright spot 2 - component system selection principles highlight 3 - risk assessment reference: the author's introduction: drip south, male, biomedicine senior engineer, based on the biopharmaceutical industry quality management work, focusing on the biopharmaceutical industry.
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