Mitigate Drug Shortage Risk With Improved Internal And External Collaboration

In recent decades, pharmaceutical manufacturing has grown increasingly complex with global supply chains becoming more fragmented. Traditional data management practices have siloed quality, regulatory, and manufacturing, impeding a more agile approach to manufacturing change control and batch release. This obstruction hampers efficient data exchange and communication between sponsors and contract partners. Consequently, drug shortages have increased in frequency, reaching unprecedented highs globally.

Regulators and industry organizations have proposed risk-based measures and incentives to ensure adequate drug supplies in response to intensified shortages over the last decade. Initiatives such as IDMP, PQ/CMC, and ICH Q12 address the need for standardized data and improved communication between stakeholders to accelerate decision-making and ultimately improve drug availability. Legacy software has created disconnected information silos, requiring manual efforts and communication from quality, regulatory, and manufacturing teams, creating unnecessary risks and hindering operational efficiency. Learn how to overcome these hurdles, and discover the key to reducing drug shortage risks.