When Guidelines Need Guidance: ICH Releases “Points to Consider”

Over the past several years, the ICH Quality Implementation Working Group has helped to develop and spearhead the adoption of ICH Q8, Q9, and Q10, guidelines which spell out the Quality by Design principles that (slowly but surely) drug manufacturers worldwide are taking to heart.

But the ICH guidelines have certainly led to confusion, and the Q-IWG has received plenty of questioning during its series of regular training workshops. As such, the group has already published FAQ documents clarifying many of the industry’s questions about Q8, Q9, and Q10, as well as workshop training materials. Various groups have worked to produce related, helpful case studies.

For further clarification, however, the working group will now publish “Points to Consider” documents, which as their subtitle ("Guide for ICH Q8/Q9/Q10 Guidelines") suggests, are intended to be, well, guidelines (or at least guidance) to the original guidelines.

Key working group member Moheb Nasr (of FDA’s CDER) recently explained some of the challenges manufacturers have had with Q8, Q9, and Q10, and why the PtC documents are needed. They “are not intended to be new guidelines,” Nasr said. Rather, they are intended to provide further clarity and facilitate regulation in regards to Q8, Q9, and Q10.

The first three Points to Consider papers are now available in one PDF:

  • Criticality of Quality Attributes and Process Parameters
  • Level of Documentation in Enhanced (QbD) Submissions
  • Control Strategy

“Points to Consider” papers to be completed by end of 2011:

  • Process Validation
  • Design Space
  • Role of Modeling in QbD

No word yet on whether the Points to Consider documents will need their own FAQs and guidelines.

--Paul Thomas

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