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    Home > Active Ingredient News > Drugs Articles > Notice on holding the workshop of "key point control and quality research practice of chemical API preparation process development"

    Notice on holding the workshop of "key point control and quality research practice of chemical API preparation process development"

    • Last Update: 2018-09-12
    • Source: Internet
    • Author: User
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    The research of API preparation technology is the starting point of drug development, and also runs through the whole process of drug development In the research of API preparation process, the importance of the whole process control, data accumulation, impurity analysis and the control of starting materials and reagents is emphasized The purpose is to determine a feasible, controllable and stable production process, and to provide basis for quality research The level of API preparation technology reflects the technical strength and scientific research level of an enterprise or research unit, and it is also a symbol of its comprehensive strength The quality of APIs has a direct impact on the quality of the finished product, and the quality comes from the concept of design (QBD), which has penetrated into all aspects of the pharmaceutical field (including the production of APIs and their products) Since January 2013, the FDA of the United States has always required that the development and production of generic drugs must adopt the concept of QBD In order to help pharmaceutical enterprises to improve the level of API preparation process, explore and improve the problems existing in the actual work, so as to further ensure the reliability of the process and improve the core competitiveness of enterprises After research, our company will hold a seminar on "key point control and quality research practice of chemical API preparation process development" in Shanghai on October 19-21, 2018 Please actively select personnel to participate We hereby inform you of the following matters: support unit: Qingdao science and technology innovation compatibility research center (polymer material expert workstation) I time and place of the meeting: time: October 19-21, 2018 (full day registration on October 19) place: Shanghai (place to determine the direct informed applicants) II Main topics of the meeting For details, please refer to Appendix I (schedule) III introduction of Lecturer: Dr an, master of pharmaceutical analysis, Shanghai Institute of Pharmaceutical Sciences, has been engaged in the research and development of new APIs under the GMP standard in GlaxoSmithKline, USA for a long time, The quality research in pilot test and production involves the analysis of process development, quality control and material declaration of all kinds of APIs from pre clinical to listing It has advanced concepts and rich experience The leading domestic API enterprises are senior executives Special lecturer of the association Dr Sun, postdoctoral engineer of Hong Kong University of science and technology, researcher of leading enterprises in China, executive vice president of Pharmaceutical Research Institute, expert of "hundred talents plan", has long been engaged in the research on the improvement and optimization of green process and crystal form of API Special lecturer of the association Mr Ding is a senior expert who has worked in famous domestic pharmaceutical enterprises and executives of foreign-funded enterprises In recent 20 years, he has rich practical experience in drug research and development, drug process development, drug analysis and production management, and participated in the translation of the third edition of the book "pharmaceutical process amplification" He is a specially appointed lecturer of the association IV participants: R & D, technical and management personnel of pharmaceutical enterprises engaged in API development, production process research, quality assurance, etc.; units providing process optimization design and technical services for pharmaceutical enterprises; relevant professionals of colleges and universities, scientific research institutes, medical institutions, etc.; relevant product and equipment and instrument manufacturing enterprises, etc V conference fee: 2500 yuan / person, including expert fee, conference fee, information fee, etc.; accommodation and food are arranged in a unified way, and the expenses shall be borne by oneself 6 Explanation of meeting form 1 Theoretical explanation, case analysis, special lecture and interactive Q & A 2 All the speakers are experts of GMP workshop of the association Welcome to call for consultation 3 The training certificate will be issued by the association if all the training courses are completed 4 The enterprise needs GMP internal training and guidance Please contact the meeting affairs group 7 Contact information (please see the relevant information below for download) attachment 1: schedule attachment 2: receipt form (please see the relevant information below for download) attachment 1: schedule days of pharmaceutical and chemical professional committee of China Chemical Enterprise Management Association September 2018 09:00-12:00 13:30-17:30 I key process control points of API R & D 1 Research and development ideas of QBD 2 Manufacturing process development and process control 3 Screening of starting materials and raw materials 4 Control strategy 5 Compliance points of pilot study 6 Comprehensive analysis and evaluation of process 7 CTD related information 8 Life cycle management 9 Case analysis 2 Evaluation points of API synthesis process 1 Selection of process line 2 Selection and control of starting materials, reagents and organic solvents 3 Intermediate physical control requirements 4 Accumulation and analysis of process data 5 Key control points after refining 6 Application requirements of CTD related writing materials 2 Process amplification of chemical API: 1 Preparation of process amplification scheme 2 Operation points of process amplification unit * large consideration of feeding quantity * consideration of temperature influence factor * consideration of mixing speed factor * consideration of extraction process enlargement * consideration of concentration / distillation process enlargement * consideration of filtration process enlargement * consideration of centrifugal process enlargement * consideration of drying process enlargement 3 Role of process enlargement data in registration declaration 4 Key transformation in process amplification 3 Process validation and analysis of relevant practical problems (case analysis) 1 Composition and scheme formulation of process validation team 2 Time node of process validation 3 Whether products of process validation can be sold 4 Relationship between process validation and cleaning validation 5 How to determine the key process steps and key process parameters 6 Deviation treatment in process validation, etc the next day, 09:00-12:00, 13:30-17:00, research strategy for the crystal form of API 1 Consistency with the original research preparation 2 How to carry out the screening of crystal form 3 The study of crystal form generality 4 The stability of crystal form 5 The study of polymorph * the influence of polymorph on drug quality * the phenomenon of drug polymorph and related issues * the consideration of drug research and development in the aspect of polymorph 6 Research on particle size of API how to introduce the concept of QBD into research and development quality of API process - practice and application 1 Guide the research of API process journal based on the concept of QBD 1 Basic concept of QBD 2 Research on impurity spectrum based on the concept of QBD (how to determine the impurity spectrum of API) 3 Ich-q9: quality risk management 4 Brief introduction of CTD based on QBD 2 How to consider the influence of preparation process and process control on related substances 3 Development practice of analytical methods based on QBD concept 1 Overview of analytical objectives 2 Evaluation of physicochemical properties of chemical synthesis 3 Technical selection of methods 4 Principle of screening parameters 5 Parameter screening and optimization 6 Risk assessment 7 Control strategy 8 Continuous improvement 9 FDA's Guide to the description of analytical methods 4 Evaluation and control of DNA reactive (mutagenic) impurities in drugs to limit potential carcinogenic risks 1 Ich-q regulatory background 2 Summary of key points of ich-m7 regulation 3 Scope of application 4 Risk assessment and case analysis of genotoxicity 6 Control strategy and case analysis 7 Summary and discussion 5 Development of analytical method for determination of trace mutagenic impurities Annex 2: "Key point control and quality research practice of chemical API preparation process development" workshop receipt form due to the limited number of participants, please register as soon as possible the name of the contact person Address, postal code, surname, gender and position Telephone, fax / E-mail
    Single room required for accommodation: Yes ○ no ○ check in time: day To date remittance account No.: remarks API process development account name: Beijing Huaxia Kaisheng Pharmaceutical Technology Center Bank of deposit: Industrial and Commercial Bank of China Limited Beijing Yuquan Road sub branch account No.: 020 006 300 920 0091778 Contact: Q Q: Mobile: Email: what are the problems encountered in combination with the actual work for this training? So that we can give feedback to the teachers and go to the meeting to discuss and answer questions Question 1
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