Risk Management for Avoidance of Drug Shortages
Cover: Shortages of essential medicines around the world have been an ongoing concern for patients, caregivers, and regulators and have been exacerbated by the COVID-19 pandemic. Many regulators have instituted requirements for reporting potential or actual drug shortages. To further minimize drug shortages, regulators in the United States and France recently established requirements for risk management on drug shortages avoidance. Such requirements could spread beyond these two countries, especially because risk management for product availability is included in the revision of the ICH Q9(R1) guideline “Quality Risk Management.”
An Evaluation of Postapproval CMC Change Timelines
Feature: As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple countries simultaneously. As a result, Boards of Health (BoHs) are challenged with approving these applications in an accelerated timeframe and accommodating the submission of postapproval chemistry, manufacturing, and controls (CMC) changes that pharmaceutical manufacturers submit after implementing improvements or optimizations.
Air Speed Qualification: At Working Position or Working Level?
Feature: The new European Commission GMP Annex 1 “Manufacture of Sterile Medicinal Products” and the equivalent Annex 2 from the World Health Organization (WHO) triggered a discussion in ISPE’s Germany/Austria/ Switzerland D/A/CH Aseptic Processing Community of Practice (CoP) Steering Committee about where to qualify air speed: “at working position” versus “at working level.” This article provides background knowledge from literature and data from experiments to enhance the discussion.
2023 ISPE Aseptic Conference Regulatory Panel
Highlights: On 7 March 2023, ISPE concluded the 2023 ISPE Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to the FDA representatives. This article offers highlights from the discussion.
Industry Panel on Annex 1 Implementation Strategies
Highlights: Annex 1, the European Union’s revised GMP requirements for the manufacturing of sterile medicinal products, will take effect on 25 August 2023. In this panel, experts involved in industry’s commenting of the draft versions of Annex 1 offered background information on how the document was developed and answered questions on its implementation.