Regulators from the European Medicines, the US Food and Drug Administration and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), welcomed the Drug Shortages Prevention Plan, which was released by the International Society for Pharmaceutical Engineering (ISPE) at its 2014 annual meeting in Las Vega, USA, and spoke about the importance of the industry approach.
ISPE developed the Plan in response to global regulatory interest in preventing drug shortages due to manufacturing and quality issues. A world first, presenting a global and holistic response uniquely addressing shortages at both the product and process levels, the Plan lays out how industry can best prevent drug shortages from occurring by identifying the root causes of supply disruptions and creating a quality culture that will ensure a robust, resilient and reliable supply of medications – some life-saving – to patients worldwide.
Part of significant effort since 2011
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