Divergent Global Change Filing Requirements Present Continuous Improvement Roadblocks, Experts Stress at ICH Q10 Conference

The power of the advancing pharmaceutical quality systems to manage change and drive continuous improvement is being hampered by the disharmony and inflexibility of the CMC filing requirements across the globe, prominent industry and regulatory experts reemphasized at a quality systems/ICH Q10 conference in Arlington, Virginia in early October.

The constraints caused by the divergent national and regional CMC change filing requirements on realizing a continuous improvement-oriented regulatory paradigm has been a recurrent theme at public meetings focused on ICH Q8-10 implementation and again drew attention at the recent quality systems forum.

At the conference, senior industry quality management met with key US and European regulators to do three days of benchmarking and brainstorming on the implementation of quality systems – how the concepts have evolved and impacted industry and regulatory processes, what the emerging goals are, and where the obstacles to further progress lie.

The conference was cosponsored by the associations PDA and ISPE in conjunction with FDA and EMA. A companion European meeting with a similar lineup of topics and speakers will be held in Brussels, Belgium on November 14-16.

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Also see the following related IPQ coverage:

ICH “Points to Consider” on Implementing Q8-10 Addresses Control Strategy Development and Filing

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

ICH Position Papers Will Address Pressing Issues in Q8-10 Implementation; EU Experience Helps Shed Light

IPQ Special Report — May 2010