ICH’s Lifecycle Management Initiative Q12 is Targeting the Tough Regulatory Issues, With Patient Supply a Driving Concern; Analytical QbD Also on Expanded ICH Agenda

The ICH Q12 effort to create a more improvement-friendly and harmonized regulatory approach to pharmaceutical product lifecycle management is being driven by concern about the availability and reliability of  supply as well as product quality and will address the “tough” regulatory issues involved, GSK CMC Regulatory Strategy VP Moheb Nasr stressed in an update on the ICH initiative in December. Nasr has been appointed to serve as Q12 rapporteur.

At a workshop on analytical method lifecycles cosponsored by USP, the American Association of Pharmaceutical Scientists (AAPS), and the IQ Consortium, held at USP’s Rockville, MD headquarters, the former director of FDA’s Office of New Drug Quality Assessment (ONDQA) provided insights into the drivers and goals of the Q12 project, in which he is playing a key role, and how they apply in the analytical context.

Nasr’s comments on the forces driving ICH’s Q12 effort internationally make clear how closely aligned it is with the transformation underway in FDA’s quality regulatory processes – an alignment that agency leadership, including Commissioner Margaret Hamburg and CDER Director Janet Woodcock, and Nasr while at FDA, has stressed is critical (IPQ October 26, 2014).

Nasr highlighted the increased emphasis being placed in developing Q12 on assuring that “we have high quality product available to the patient.” Underpinning the ICH effort is the belief that “harmonization and efficiency of lifecycle management will lead to better availability and reliability of supply.”

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