The Parenteral Drug Assn. (PDA) announced Sept.10 its plans to publish a Technical Report on the prevention and management of drug shortages. Short supplies and disrupted supply chains of critical, life-saving medicines are becoming an increasing problem for healthcare practitioners and patients in recent years.
Regulators in the U.S. and Europe have been reaching out to industry to find ways to mitigate the kinds of shortages driven by manufacturing disruptions resulting from quality problems and regulatory enforcement activities.
PDA has assembled a team of volunteers representing large and small pharmaceutical and biopharmaceutical manufacturers to develop an industry guidance on this critical topic. The Technical Report, planned for publication in early 2015, will introduce two unique foundational concepts:
1. Risk-based triage on how to establish end-to-end controls for drug shortage risks based on criticality of the product and the overall product risk evaluation;
2. Holistic framework and template for establishing a drug shortage prevention and response plan.
“PDA is pleased to be working on this important initiative in support of regulatory initiatives in the U.S. and EU,” said PDA President Richard Johnson at a press conference held at the Renaissance Hotel in Washington, DC, during the 2014 PDA/FDA Joint Regulatory Conference. “PDA’s activities in quality risk management started in 2009, and the association has published four Technical Reports on the topic since then.”
This series of PDA Technical Reports started with Technical Report No. 54: Quality Risk Management, published in 2012; three annexes to that report have published subsequently. The new drug shortage document will continue that series.
PDA also announced at the press conference that a revised PDA Points to Consider on Pharmaceutical Quality Metrics is ready for publication in the PDA Journal of Pharmaceutical Science and Technology later this month. The revised paper includes definitions of various quality metrics and is intended to prompt discussion at the second PDA workshop on quality metrics scheduled for December this year.
PDA is a global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide.