A complete set of guiding documents for research on Drug Impurities at home and abroad

Impurity research is an important part of drug research and development It includes the selection of appropriate analytical methods, the accurate resolution and determination of impurities, and the determination of reasonable limits of impurities based on the results of pharmaceutical, toxicological and clinical studies This research runs through the whole process of drug research and development Our country has experienced the process of rough to strict management of drug impurities, and the research "degree" has reached a very high level Some experts, such as Mr Xie Mufeng, even think that there is a general situation of excessive impurity research in the industry today in our country, thinking that the deeper the research is, the more impurities are formulated in the quality standard (impurities are listed and even 26 English letters have been arranged); The higher the requirements, the better How to grasp this "degree" and grasp the internal spirit of impurity research requires us to comprehensively interpret the relevant laws and regulations, guidance documents at home and abroad The following is the results of the search by inputting "impurities" or "securities" keywords through the drug intelligence data policy and regulation database (http://db.yaozh.com/policies), including the knowledge of ICH, FDA, EU, CFDA, and experts from the drug Audit Center on impurity research, for your reference Click the title name to view the full text: No regulation Title release date 1 API impurity research and control analysis 2015.06.01 2 Strategy Discussion on antibiotic impurity research and control 2015.06.01 3 M7 assessment and control of DNA reactive (montage NIC) securities in pharmaceuticals to limit poten t ial pharmaceutical risk 2015.05.27 4 Q 3 D impuriti es: guideline on elementary impurities 2015.01 5 Analysis of common problems in the research of generic drugs impurities in China Analysis and control of organic impurities in fasudil hydrochloride on June 23, 2014 Discussion on the research and control strategy of antibiotic impurities Securities: guideline for residual solutions (ICH topic Q3C (R5)) (impurities: guidelines for solvent residues & nbsp; (ICH theme Q3C (R5))) 2011.03.17 influences: Guide for residual solvents 2011.02.04 18 andas: influences in drug products 2010.11.26 19 technical requirements for impurity control of antibiotic drugs 2010.04.06 20 challenges and Reflections on impurity research in drug research and development in China 2010.21 Research on non enantiomeric impurities in synthetic peptide drugs ﹣ Kang Jianlei 2010 22 progress in research and quality control of isomeric impurities in lactam antibiotics ﹣ Jiang Yu 2010 23 discussion on impurity analysis and control of isoniazid API ﹣ Chen Zhen 2010 24 challenges and Reflections on impurity research in drug research and development in China 25 andas: influences in drug substances 2009.07.15 26 Control of organic impurities in drugs - Su Jiayan 2009 27 discussion on the formulation method of drug impurity limit - he Wu 2009 28 research on heteroisomeric impurities in synthetic polypeptide 2008.11.20 29 research on non patent drug impurities - 3: management perspective of non patent drug application (anda) - 2008.08.04 30 research on non patent drug impurities - 4: management perspective of non patent drug application (anda) - 2008.08.04 31 Research on non patent drug impurities-1 July 16th, 2008 32 research on non patent drug impurities-2 July 16th, 2008 33 discussion on risk control in impurity research Significance and problems of destructive test in the establishment of impurity inspection and analysis method Analysis of problems in 2007.11.20 41 guiding principle for impurity research of chemical drugs 2007.08.23 42 EMEA guiding principle for impurity limit of genotoxicity The basic idea of research on the source of impurities in new drug products (revision 2) 2006.08.4 48 chemical compound preparations 2006.07.04 49 impurities in new drug products 2006.06.02 50 Limits of genotoxic impurities 2006.06.51 control of inorganic impurities in the quality research of APIs 2006.04.18 52 FDA's guidelines on the application of generic drugs for the study of impurities in raw materials (discussion draft) introduced the characteristics and basic ideas of impurity research in the compound preparation of chemical drugs 2006.02.28 53 Understanding of common problems in the technical guidelines for impurity research Discussion on the review of the existing research materials of the national standard chemical drug impurity inspection methodology Impur ities in new drug products (Revision) 2003.02 63 impurities in new medical products (ICH Q3B (R2)) (ICH Q3B (R2))) 2003.02 64 maintenance of note for guidance on impurities: permanent solutions (notes on guiding principles of impurity research: solvent residues) 2002.11 65 ICH Q3C maintenance procedures for the gui dance for industry Q3C impacts: stationary solutions 2002.02.11 66 impacts testing: impacts in new drug substances (ICH Q3A R2))) 2002.02 67 impacts testing: impacts in new drug substances Impurities in API) 2002.02 68 NDAs: impurities in drug substances 2000.02.1 69 Q3C impurities: residuals solutions [2011.12.24 70 impurities: residuals solutions (ICH Q3C (R4)) (impurities: residual solvents (ICH Q3C (R4))) 1997.09 71 position statement on DNA and host cell protein improvements, Routine testing versus validation studies 1997.06 72 experiments: residual solutions 1995.09 note: the intellectual property rights of the above articles are owned by If you need to reprint, please indicate the source and the link of this article.