ICH’s newly-released “Points to Consider” (PTC) on implementing Q8-10 underscores the need for QbD-based marketing applications to provide a scientific justification for the proposed control strategy, including enough information, clearly enough organized, for regulators to understand how the firm developed it.
Along with the control strategy justification, ICH is looking for applicants to provide: ● the scientific rationale for the studies conducted ● a concise description of the methods used to conduct the studies and analyze the generated data, and ● a summary of the results and conclusions drawn from the studies.
What to submit in a QbD application – and regarding the control strategy in particular – was a key area of questioning during the 2010 ICH Q8-10 “training workshops” held in the three ICH regions. The workshops, sponsored by the Q8-10 Implementation Working Group (IWG), provided industry and regulators the opportunity to raise issues that were felt to need further clarification in shifting to a more QbD-oriented regulatory paradigm.
As a result of the workshops, the IWG made the decision to develop the Points to Consider as a means of providing more assistance on the issues and questions raised (IPQ “In the News,” May 1).
[Further review of the new PTC and a summary of the US ICH training workshop discussions on the control strategy, presented at its conclusion by Pfizer’s Robert Baum, is available for subscribers here. Nonsubscribers can purchase the story for $95 by contacting Jonathan Trethowan (Jonathan@ipq.org).]
Also see the following recent related stories:
Control Strategy is Nexus for QbD Regulatory Paradigm, US and EU Regulators Affirm
QbD Imperatives Reaffirmed by Industry Expert Berridge at ISPE Conference
ISPE and PDA Initiatives on ICH Q8-10 Implementation Begin Bearing Fruit
