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The International Society for Pharmaceutical Engineering (ISPE) released its Drug Shortages Prevention Plan as part of an initiative to address drug shortage prevention due to manufacturing and quality issues.
In response to the growing problem of drug shortages, the International Society for Pharmaceutical Engineering (ISPE) has released its Drug Shortages Prevention Plan. The plan, based on ISPE’s 2013 ISPE Drug Shortages Survey, presents industry with a plan to prevent drug shortages. The plan was created in a collective effort by industry experts and regulatory agencies in the US and Europe.
In the plan, ISPE suggests that companies investigate root causes for drug shortages and create a quality culture to ensure a reliable supply of drugs. The plan lays out a holistic approach for identifying root causes of drug shortages on technical, quality systems, and management levels. An emphasis on quality is expressed in chapters on cross-function and cross-level cooperation, third-party quality oversight, and process- and production-related root causes.
A discussion on quality metrics is also provided including sections on supply-chain practices. The plan also details the role regulatory agencies play in preventing drug shortages and how industry can work with regulators to ensure a robust supply of medicines.