Since 1976, the International GMP Conference has been co-sponsored by the University of Georgia College of Pharmacy and the U.S. Food & Drug Administration. However, this year, through no fault of the Agency, the FDA was unable to attend. This was unfortunate (to say the least), especially as this public-private collaboration amongst a number of different consortia for the sake of patient safety had been progressing very well until now. Unfortunately, due to the FDA’s absence, several critical themes and issues were discussed among opinion leaders across the international pharma community but without a regulator’s perspective.

The cross-industry representation was impressive with over 150 registrants from over sixty organizations. This included:

  • Nineteen speakers from fourteen organizations
  • Nineteen states
  • Four countries

Key themes discussed at the conference included Quality Risk Management (QRM), Artificial Intelligence (AI), and the whirlwind of changes occurring at the FDA. I gave a presentation that encompassed many of these themes; the basis for my presentation was application of the draft FDA guidance “Risk Management Plans to Mitigate the Potential for Drug Shortages” to the current drug shortage problem. This guidance was intended to be implemented as a mitigation plan from the previously published FDA report 2019 Drug Shortages Report, Updated February 21, 2020. A related body of work, including Building a Resilient and Secure Pharmaceutical Supply Chain: The Role of Geographic Diversification, by the Duke-Margolis ReVAMP Drug Supply Chain Consortium, which Lachman has contributed to as a founding member, was also cited and leveraged. Because this conference focused on international aspects of GMP, my presentation centered on the global supply chain, not just the U.S. market. For this reason, a global risk tool was used to exemplify how to assess a global supply chain. A follow-up for interested parties can be found in Assessment of the supply chain vulnerabilities for the first tranche of the Union list of critical medicines (June 2024), a technical report published by the European Commission.

The themes discussed at the conference essentially reiterated the goals of ICH Q10, which aspires to integrate the following three concepts: (1) Establish and maintain a state of control (section 1.5.2); (2) Facilitate continual improvement (section 1.5.3); and (3) Integrate knowledge management and Quality Risk Management (section 1.6). A key reminder for all of us is that these activities are needed regardless of any policy changes affecting the FDA as the industry’s goal is to help and protect patients, and this goal never wavers, regardless of political forces.

Please contact Lachman Consultants at LCS@LachmanConsultants.com if you are looking for more information on how to take these quality enablers and turn them into competitive advantages for your firm.