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ICH Prepares for Future Topics

The ICH (International Council for Harmonisation) met in Kobe, Japan, from June 2 – 7, 2018. The corresponding press release provides insight on the topics discussed.


Two announcements have to be highlighted for the area of GMP. The Assembly agreed to begin work on two harmonising guidelines Q13 and Q14 to

  • Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14), and on
  • Continuous manufacturing (Q13)

Work will start with developing formal concept papers and work plans.

The  Assembly  also  discussed  future  strategic  areas  for  harmonisation by endorsing a  strategic reflection  paper  entitled  Advancing  Biopharmaceutical  Quality  Standards  to  Support  Continual Improvement and Innovation in Manufacturing Technologies and Approaches.

Also the number of Council members is constantly increasing. There are now 16 ICH Members and 27 observers on board:

•             CFDA, China, HSA, Singapore and MFDS, South Korea join the current standing members

•             BIO and IGBA join the current industry members

•             TFDA (Chinese Taipei) becomes a new regulatory member.

•             Moldavia (MMD), Malaysia (NPRA), Armenia and TITCK (Turkey) are new observers


The next ICH meeting takes place on 10-15 November 2018 in Charlotte, NC, USA.
Can you brief about Q14-Continuous Manufacturing. What are the topics will get covered under said guidance and how it will help the industry.
Sandip Pawar 2018-08-29
Thank you very much for your interest in our news/newsletter and your question regarding details for the upcoming new ICH Guidelines ICH Q13 (Continous Manufacturing) and Q14 (Analytical Procedure Development/Validation). Unfortunately, ICH has not yet published any details on the planned guidelines. Therefore, the only information we have is stated in the press release dated June 2018: http://www.ich.org/fileadmin/Public_Web_Site/News_room/B-Press_Releases/ICH_Press_Releases/ICH36Kobe_PressRelease_Final_2018_0621.pdf If we have any news on this we will publish the information on our website and in our newsletter LOGFILE.
Editorial Office GMP Publishing 2018-08-30
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