ISPE Plan To Prevent Drug Shortages To Be Released October 14
TAMPA, Fla., Oct. 2, 2014 /PRNewswire-USNewswire/ -- ISPE, the International Society for Pharmaceutical Engineering, will release its Drug Shortages Prevention Plan on 14 October at its 2014 Annual Meeting in Las Vegas, Nevada.
The ISPE Drug Shortages Task Team developed the Plan as part of a multi-association initiative launched in response to a request from the European Medicines Agency (EMA) for a collaborative action plan aimed at 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.
The newly developed Drug Shortages Prevention Plan builds on the results of ISPE's 2013 Drug Shortages Survey that cited manufacturing quality issues as a major cause of drug shortages. This Plan is global in nature and represents a continuum of work done to date supporting the US Food and Drug Administration (FDA)'s Strategic Plan for Preventing and Mitigating Drug Shortages and ongoing communications with other health authorities, such as Health Canada and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
"ISPE's Drug Shortages Prevention Plan is part of a significant and continuing effort since 2011 to ensure a safe, quality and reliable drug supply," said ISPE President and CEO John Bournas. "We owe patients a sense of security by meeting their expectations for a reliable and continuous supply of the medications that are so important to them and their families. Accordingly, when members of the pharmaceutical industry discover and put to work the valuable insights included in the Plan, particularly those promising to strengthen the integrity of the supply chain and those describing how to place greater emphasis on end-to-end quality, a real difference can be made in the lives of patients."
In an effort to provide robust and reliable systems, the Plan employs a "six dimension" framework comprised of: Corporate Quality Culture; Robust Quality System; Metrics; Business Continuity Planning; Communication with Authorities; and Building Capability. Each chapter provides answers to questions posed within each of the six dimensions and offers "real world" case studies that illustrate successful strategies to avoid supply disruptions and shortages.
As a global effort at stopping drug shortages before they occur, the Plan represents a collective investigative and remedial effort by pharmaceutical and biopharmaceutical industry experts. It has been reviewed by regulators from the EMA and US FDA, and by national competent authorities including the Spanish Agency of Medicines and Medical Devices (AEMPS) and the Medicines and Healthcare Products Regulatory Agency (MHRA).
In creating the Plan, the Task Team engaged with leadership from more than 30 major pharmaceutical companies and included input from experts from several pharmaceutical associations, including the Association of the European Self-Medication Industry (AESGP), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic medicines Association (EGA), the Parenteral Drug Association (PDA), and the Plasma Protein Therapeutics Association (PPTA).
For more information on ISPE's Drug Shortages Initiative, http://www.ispe.org/drug-shortages-initiative or contact Ms. Carol Winfield, Director of Regulatory Operations, cwinfield@ispe.org, 813-960-2105 ext 215.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Brussels, Belgium, Singapore and Shanghai, China. Visit www.ISPE.org for more information.
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