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ICH Advances Three Guidance Documents

Posted 02 December 2016 | By Zachary Brennan 

ICH Advances Three Guidance Documents

The International Council for Harmonisation (ICH) earlier this week announced the advancement of two guidelines to Step 4, or the implementation period of its process, and one question and answer document on the development and manufacture of drug substances to Step 2b of its process, meaning it enters a consultation phase.

On the Step 4 front, the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (GCP) advanced.

“The current amendment (ICH E6(R2)) aims to encourage sponsors to implement improved oversight and management of clinical trials, while continuing to ensure protection of human subjects participating in trials and clinical trial data integrity,” ICH said.

In addition, the ICH Q3C(R6) Guideline also advanced, and it revises the permissible daily exposure (PDE) for methyl isobutyl ketone (MIBK), and adds triethylamine (TEA) as a new solvent.

As far as the 19-page ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), focusing on the selection and justification of starting materials, ICH says it is “intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials and on the information that should be provided in marketing authorisation applications and/or Master Files.”

The Q&A includes questions like:

  • "What information should be included in the application about a starting material that is a commercially available chemical?"
  • "How should an applicant determine which manufacturing steps impact the profile of mutagenic impurities in the drug substance as part of the selection and justification of starting materials?"
  • "What is meant by impurities that 'persist' in ICH Q11 Example 4?"

Back in 2012, the US Food and Drug Administration (FDA) adopted Q11.

Stakeholders from ICH regions may provide comments on the draft Q11 Q&A document by emailing the ICH Secretariat. More details are on ICH’s Open Consultation page.

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