[CMC Research] [Live streaming seminar] Important points for impurity control in pharmaceutical manufacturing and response to authorities ~ Handling of elemental impurities and genotoxic impurities and generic issues ~ Held on October 25th (Friday) Sponsored by: Co., Ltd. ) CMC Research
CMC Research Press release: September 27, 2024 [Live streaming seminar] Important points for impurity control in pharmaceutical manufacturing and response to authorities ~ Handling of elemental impurities and genotoxic impurities and generic issues ~ Held on Friday, October 25th Sponsored by: CMC Research Co., Ltd. ★Easy-to-understand explanation of various knowledge about impurity control in pharmaceutical manufacturing, how to deal with authorities, and how to establish a system!
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publication of “Important points for impurity control in
pharmaceutical manufacturing and response to authorities – Elemental impurities and genotoxic impurities”. Mr. Mitsunori Hashimoto (Pharmaceutical R&D Consulting) gave a seminar titled “Handling of Generics and Generic Issues”. The event will be held via live streaming using ZOOM from 10:30 on Friday, October 25, 2024 (with missed streaming). Tuition fees are: General: 55,000 yen (tax included), Our e-mail newsletter members: 49,500 yen (tax included), Academic price: 26,400 yen (tax included) (with materials). There will also be time for a question and answer session, so please come and join us. View details [Knowledge gained at the seminar] Knowledge about GMP, ICH, PIC/S Handling of impurities in pharmaceutical manufacturing Knowledge about elemental impurities, genotoxic impurities, and residual solvents Contents of change management and standard value setting, quality equivalence evaluation, ICH Q11, ICH M7 Trends in the pharmaceutical industry [Seminar target audience] Pharmaceutical related workers in general 1) Seminar theme and date and time Theme: Important points for impurity control in pharmaceutical manufacturing and response to authorities ~ Handling of elemental impurities and genotoxic impurities and generic issues ~ Date and time: October 25, 2024 (Friday) 10:30-16:30 Participation fee: 55,000 yen (tax included) *Includes materials and missed broadcast ＊ E-mail newsletter subscribers: 49,500 yen (tax included) * Academic price is 26,400 yen (tax included) Lecturer: Mr. Mitsunori Hashimoto Representative Director, Pharmaceutical Research and Development Consulting In recent years, there have been many quality problems with pharmaceuticals. In particular, there are many problems regarding generic drugs. Since pharmaceuticals are directly
administered to the human body, special attention must be paid to their quality. Regarding quality, impurities are particularly noteworthy. If impurities are not properly handled, unexpected situations may develop and affect the survival of the company. As recently revealed with the valsartan issue, nitrosamine contamination has become a major problem and has come under stricter scrutiny since it has been detected in other products. The handling of genotoxic impurities is now clearly specified in ICH Q11, and it is now essential to take into account the handling of ICH M7. Understanding and working on ICH and PIC/S GMP guidelines is the key to solving problems, such as developing production processes that do not cause quality problems, solving problems by handling impurities, and responding to regulatory authorities. We will explain in an
easy-to-understand manner how to deepen your understanding of impurities and establish a system that can produce products without causing problems. [From the instructor] When it comes to the quality of pharmaceuticals, a company’s ability can be determined by how it handles impurities. Recently, the handling of genotoxic impurities has come under strict scrutiny, and there are cases where it can lead to great losses if not handled with knowledge. Let me explain these points in an easy-to-understand manner. *This seminar will be a live-streaming seminar using the video conferencing tool “Zoom” on the day. Please refer to the tool for recommended environment. We will contact you via email with the viewing URL at a later date. ★Recording or filming during the course is strictly prohibited. [★With missed delivery] – If you apply for the webinar, we will also provide you with a “missed broadcast” service using ZOOM. ・ With missed
broadcasts, you can watch the recorded video of the webinar for a certain period of time. ・If you want to review the webinar or have difficulty attending it on the day, you can watch the video as many times as you like during the period. 2) How to apply Please apply from the CMC Research seminar site. We will contact you via separate email with the viewing URL. Please see the URL for details. View details 3) Introduction of seminar program 1.
Pharmaceuticals and GMP a) About GMP b) Purpose of GMP c) GMP and responsibility d) About ICH; Q7,Q9,Q10,Q11,Q13 2. Movement of PIC/S a) Recent trends in PIC/S b) Future movements of PIC/S 3. Generation of impurities in pharmaceutical manufacturing a) Generation of impurities in drug substance manufacturing; Selection of starting materials b) Generation of impurities during drug manufacturing c) Stability and impurities; considerations for scale-up 4. What is an impurity? a) Impurity guidelines b) Types of impurities c) Standard setting for organic impurities d) What is impurity profile e) Narrowing down of impurity candidates f) Impurity profile establishment procedure g) What is the same impurity profile 5. About the threshold a) What is a threshold? b) How to handle the amount of impurities 6. Genotoxic (mutagenic) impurities; mainly ICH Q11 and ICH M7 a) Scope of application of ICH M7 guidelines and application to the field b) Regulation against genotoxic (mutagenic) impurities c) Classification and control of genotoxic (mutagenic) impurities d) Example of alert structure e) Management of impurities derived from the manufacturing process f) Nitrosamine issue and response to regulatory authorities; Valsartan issue 7. Management of elemental impurities a) ICH Q3D and the 18th revised Pharmaceutical Affairs Law b) Safety assessment of elemental impurities c) Classification of elements d) Risk assessment and management of elemental impurities 8. Residual solvent a) Class 1, 2, 3 types b) PDE value 9. Quality and side effects a) Tryptophan incident b) Thalidomide incident c) Lessons from drug damage and pharmaceutical regulations 10. How to handle impurities in quality equivalence evaluation a) Points of quality equivalence b) Quality equivalence evaluation and impurities c) Change management: Purpose, target, and content of change management Examples of major change management d) Change application classification in Japan, US and EU e) Assembling change management 11. Preparation of documents such as application materials a) About CTD b) Starting materials and impurities in the manufacturing process c) How to handle raw data d) Differences among the three poles e) Points pointed out by the authorities 12. Trends in the generic drug industry a) Trends in the generic drug industry b) Generic problem 13. Trends in the
pharmaceutical industry a) New drug development status b) Large-scale M&A 14. Summary 4) Instructor introduction [Lecturer career] March 1966 Completed master’s program, Faculty of Pharmacy, Kyushu University April 1966 Joined Sankyo Co., Ltd. Production Technology Research Institute April 1970-March 1973 Study abroad at Tokyo Institute of Technology with Professor Mitsuaki Mukaiyama, obtained Doctor of Science degree September 1976 – August 1977 Study abroad at M.I.T. Prof.Hecht Laboratory September 1977 – August 1978 Study abroad at U.C.I.Prof.Overman Laboratory August 1989 Worked at International Development Department March 1992 – December 1997 Worked as head of research and development at Sankyo Pharma GmbH (Munich, Germany) June 2002 Managing Director of Research and Development, Sankyo Kasei Kogyo Co., Ltd. October 2006 Established Pharmaceutical Research and Development Consulting December 2010 Drug Discovery Partners was launched with 8 people To the present [Activities] Corporate consultation, lectures, writing, Auditor of the Japan Society of Process Chemistry View details 5) Information about upcoming webinars (online distribution seminars) 〇 Key points of distillation technology and applied research using AI Date and time: September 30, 2024 (Monday) 10:30-16:30
https://cmcre.com/archives/125881/ 〇Causes of scale-up troubles during production of chemicals and pharmaceutical ingredients and how to solve them Date and time: October 1, 2024 (Tuesday) 10:30-16:30 https://cmcre.com/archives/125215/ *Includes missed delivery 〇Silane coupling agent: reaction mechanism and usage Date and time: October 2, 2024 (Wednesday) 13:30-16:30 https://cmcre.com/archives/125905/ 〇Microwave decomposition and recycling of PET bottles Date and time: October 3, 2024 (Thursday) 13:30-16:30
https://cmcre.com/archives/127114/ 〇Trends in materials and
technologies for new displays for IT/vehicles, AR/VR/MR etc. Date and time: October 4, 2024 (Friday) 13:30-16:30
https://cmcre.com/archives/124866/ ○ Concept of impedance measurement of lithium-ion batteries for battery management Date and time: October 8, 2024 (Tuesday) 10:30-16:30 https://cmcre.com/archives/122185/ ○Recycling of plastics in the zero carbon era Date and time: October 8, 2024 (Tuesday) 13:30-16:30 https://cmcre.com/archives/125994/ *Includes missed delivery ○ Fundamentals and key points of procedures and methods for sensory evaluation of food Date and time: October 9, 2024 (Wednesday) 10:30-16:30 https://cmcre.com/archives/125425/ *Includes missed delivery ○Able to play an active role and grow in the global AM (Additive Manufacturing) market Victory steps to become a powerful player, pursuit of unexplored possibilities Date and time: October 9, 2024 (Wednesday) 13:30-16:30
https://cmcre.com/archives/125476/ ○Regulations and SDGs regarding the supply and recycling of EVs and EV batteries ~ EU battery regulation, battery passport, carbon footprint ~ Date and time: October 10, 2024 (Thursday) 13:30-16:30 https://cmcre.com/archives/125969/ ○Basics of wet coating, single layer and multilayer coating methods, die film thickness distribution, patents, and coating failure Date and time: October 11, 2024 (Friday) 13:30-16:30
https://cmcre.com/archives/114204/ ☆Click here for a list of upcoming webinars! ↓ https://cmcre.com/archives/category/cmc_all/ 6)
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