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The ISPE Drug Shortages Team continues to work to assure the reliable supply of medicines to patients by developing actionable plans for the prevention of shortages resulting from manufacturing issues.

ISPE Developing Gap Analysis Tool to Help Ensure an Uninterrupted Supply of Medicines

International Society for Pharmaceutical Engineering (ISPE) announced at its Annual European Conference in Frankfurt, Germany, the development of a tool to aid manufacturers in locating gaps in production and quality systems – an important element in solving of shortages in the international supply of medicines.

The Drug Shortage Prevention Gap Analysis Tool, being developed by global industry experts known as the ISPE Drug Shortages Task Team, will help prevent today’s global supply chain quality problems that, in recent years, have led to serious shortages of medicines and a negative impact upon patients. An early draft of the tool will be unveiled on 6 May 2015 in Frankfurt. Feedback gathered at the Conference will be used to refine the tool so that it is an effective and applicable system for ensuring the reliable supply of medicines.

ISPE Drug Shortages Prevention Plan for the Pharmaceutical Industry

The Plan – a first for the industry – was developed by ISPE and its expert pharmaceutical and biopharmaceutical industry members and describes how industry can best prevent drug shortages from occurring by discovering root causes and through creating and sustaining organizational cultures supported by leadership, business processes and quality systems.

European Drug Shortages Prevention Task Force

At the request of the EMA, ISPE is coordinating a multi-association task force charged by EMA with delivering a single, collaborative action plan for the prevention of drug shortages resulting from manufacturing quality issues.

The inter-association Task Force is comprised of members from

  • ISPE
  • Parenteral Drug Association (PDA)
  • European Federation of Pharmaceutical Industries and Associations (EFPIA)
  • the European Generic medicines Association (EGA)
  • Plasma Protein Therapeutics Association (PPTA).

And has the support and participation of

  • European Medicines Agency (EMA)
  • Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
  • Irish Medicines Board (IMB)
  • French National Agency of Medicine and Health Products Safety (ANSM)
  • Medicines and Healthcare Products Regulatory Agency (MHRA/DoH)

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