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PDA will publish a technical report on quality risk management aspects of drug shortages in early 2015.
The Parenteral Drug Association (PDA) has announced plans to publish a technical report on the prevention and management of drug shortages in early 2015.
The organization reports it has assembled volunteers representing large and small bio/pharmaceutical manufacturers to develop the industry guidance. The report will cover 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; and a 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 US and EU," said PDA President Richard Johnson. "PDA's activities in quality risk management started in 2009, and the Association has published four Technical Reports on the topic since then."
The 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 reports.
PDA also announced that a revised PDA Points to Consider on Pharmaceutical Quality Metrics will be published in the PDA Journal of Pharmaceutical Science and Technology in September. 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.