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Balancing Manufacturing Quality Improvements and Drug Shortage

Pharmaceutical Quality

Day & Time:
June 18, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:

Room Number:



Balancing Manufacturing Quality Improvements and Drug Shortage

Jeannie C. David, MS
Senior Program Management Officer, CDER Drug Shortage Staff
FDA, United States

Drug shortages are a significant public health threat that can delay, and in some cases even deny, critical care for patients. Critical drug shortages that involve issues with drug manufacturing tend to be persistent. This session will discuss key considerations to promoting and sustaining high quality drug manufacturing while ensuring a reliable supply of critical medicines. Purchase of new equipment, renovation of facilities, or implementation of new manufacturing processes and technologies are effective long-term solutions to shortages. However, it remains critical to patients when no alternative medicines are available, for manufacturers to be able to implement these changes while avoiding disruptions in ongoing supply. How does one improve manufacturing and quality systems to ensure a reliable supply of critical medicines in the long term while maintaining supply in the short term? This session will focus on case studies of sterile injectables, a dosage form with challenging considerations and timelines, to learn what has contributed to successful implementation and the limitations to overcome. We will cover manufacturing changes, communications with the FDA, management of production and supply, and submitting changes to the FDA. The audience will gain an overview of industry efforts to improve manufacturing facilities and products while avoiding shortages and the FDA's role. The session will also describe publicly available drug shortage related information, and early notification as a critical tool to mitigate and prevent shortages.

Learning Objective(s):
Describe key considerations in high quality drug manufacturing; Recognize industry efforts to mitigate or prevent shortages and the FDA's role; Identify how to interpret drug shortage information.

Presentation(s) & Speaker(s):
Quality Aspects of Drug Shortages
Frances M. Zipp
Lachman Consultants, United States

Industry Perspective
Patrick Gondek
Director, US Commercial Quality
Hospira, United States

FDA Perspective
Jeannie C. David, MS
Senior Program Management Officer, CDER Drug Shortage Staff
FDA, United States