We often make decisions about our purchases based on basic expectations of quality. When purchasing a laptop, smartphone, a medicine, etc., we take for granted that the manufacturer has factored in certain levels of quality control and quality assurance of the products during production. Planning for malfunctions or supply shortages is not common. However, the pursuit of quality is endless, as the quality standards for products are continually increasing.

As a way to address the increasing quality standards in Medicines Development and to foster a greater commitment to quality in pharmaceutical manufacturing, the FDA sponsored an initiative, “Drug Quality Management Maturity (QMM) Program”.  “QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes in place to achieve quality objectives and promote continual improvement. Such business processes reduce the likelihood of supply disruptions and shortages.”1

The initiative was spearheaded by Michael Kopcha, PhD, RPh. Meetings were held on May 24th and 25th, 2022 to begin work on this issue. The provided the opportunity for stakeholders to learn more about facilitation of a quality management program as well as engaging with the FDA. In attendance were pharmaceutical purchasers, distributors, wholesalers, manufacturers, international regulators, among other relevant parties. The goal is continued collaboration among stakeholders and to create future opportunities to share ideas and exchange feedback around Quality Management.

Read all the details of this initiative here.

References

  1. Office of the Commissioner. (2022, May 17). FDA Seeks to Engage Stakeholders on Key Considerations for a Drug Quality Management Maturity Program. U.S. Food and Drug Administration. https://www.fda.gov/news-events/fda-voices/fda-seeks-engage-stakeholders-key-considerations-drug-quality-management-maturity-program

Disclaimers

  • The material in these reviews is from various public open access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred