News about GMP/cGMP

09.09.2016

ICH: Additional Training Modules to ICH Q3D

As previously announced, the International Council on Harmonization (ICH) has now published the additional two training modules to ICH Q3D Elemental Impurities on its website. The modules 8 (case studies) and 9 (FAQs) are part of a comprehensive training programme prepared by the ICH Implementation Working Group (our news of March 2016).

The Modules comprise:

  • Module 8-1a: Case Study 1A Solid Oral Drug Product (14 pages)
  • Module 8-1b: Case Study 1B Solid Oral Drug Product (9 pages)
  • Module 8-2: Case Study 2 for Parenteral Drug Product (14 pages)
  • Module 8-3: Case Study 3 for Parenteral Recombinant Protein Drug Product (17 pages)
  • Module 9: Consolidated FAQs  (4 pages)

The Q3D Training Modules 8-9 can now be found on the ICH website and are available in form of a zip file.


Soure:

ICH: Newsroom

 



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