QRM Process

PDA Prepares New Drug Shortage Prevention Guidance

Sep 11, 2014

Pharmamanufacturing staff

In his plenary delivered to Parenteral Drug Association’s (PDA) members attending the 2014 PDA/FDA Joint Regulatory Conference (September 8-10, Washington, D.C.), Amgen’s executive vice president of operations Madhu Balachandran presented his company’s Defense-in-Depth strategy in the fight against manufacturing quality-related drug shortages. His presence and talk to attendees served as a perfect example of how PDA is connecting people, science and regulation to manage such a complex issue while supporting its members and the industry in their efforts to address supply integrity and its relation to drug quality at the operational level.

It’s within this setting that PDA announced its plans to publish a new Technical Report (TR) on the prevention and management of drug shortages. Planned for publication in early 2015, the document 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. 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 U.S. and EU,” said PDA President Richard Johnson, explaining in remarks to the press that “in this regard, PDA’s mission … is focused, on helping to define a way to proactively manage product quality and patient safety throughout manufacturing operations and quality processes … moving from corrective to proactive action.”

In provided talking points, PDA noted that in 2012, given the growing global issue on drug shortages, the Association decided it needed to add another annex covering drug shortages to the TR 54 series; the first draft of this TR said PDA was set to be finalized at a Drug Shortages Workshop the Association held just after the PDA/FDA Joint Conference.

PDA’s activities in quality risk management started in 2009 said Johnson, resulting in TR 54 and its annexes and a foundation. According to PDA in November 2013, under EMA’s request, and inter-association task force was formed with PDA, ISPE, EFPIA and EGA to develop solutions for the root cause analysis, communication and prevention of drug shortages caused by manufacturing quality issues. “Each of the four associations,” said PDA, “are addressing aspects of this topic in a manner that brings the unique and complimentary perspectives from each association for the development of solutions for drug shortages.”