ICH has released the second half of its “Points to Consider” (PTC) on implementing Q8-10 with advice on: ● the use of models ● development of design space as part of the control strategy, and ● the use of process validation and continuous verification strategies.
The December, 2011 document completes the Q8-10 Implementation Working Group (IWG) effort to address questions that arose during the 2010 ICH Q8-10 “training workshops” held in the three ICH regions and marks the end of the IWG’s tenure.
The first installment of the PTC – covering ● critical quality attributes and parameters ● the control strategy, and ● the level of documentation recommended to support a quality-by-design (QbD) application – was released in June, 2011 (IPQ “In the News” July 18, 2011) All six topics are now covered in one document.
In its introduction, the Points to Consider explains that it is intended “to provide clarity to both industry and regulators and to facilitate the preparation, assessment and inspection related to applications filed for marketing authorizations.”
The guide advises that the development approach needs to be adapted based on the complexity and specificity of the product and process, and encourages applicants to contact regulatory authorities regarding questions related to specific information to be included in their application.
It also emphasizes that using the QbD approach “does not change regional regulatory requirements, but can provide opportunities for more flexible approaches to meet them. In all cases, GMP compliance is expected.”
The new section covering models, design space and process validation comprises the last eight pages of the 16-page document.
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