ISPE Addresses Sourcing, Manufacturing, and Quality Issues in Drug Shortages Prevention Plan

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-28-2014 19:03


The International Society for Pharmaceutical Engineering (ISPE) has issued preliminary information on its Drug Shortages Prevention Plan, which is aimed at guiding the pharmaceutical and biopharmaceutical industry in establishing reliable and robust supply chains to mitigate drug shortages. The plan was created from a cross-industry initiative in response to a 2013 request from the European Medicines Agency to address the prevention of drug shortages caused by manufacturing and quality issues. The complete ISPE Drug Shortage Prevention Plan will be published in October 2014.

In developing the Drug Shortages Prevention Plan, the ISPE Drug Shortage Task Team used the results of ISPE’s Drug Shortages Survey, conducted in 2013, as a starting point for developing strategies and practices to prevent shortages. The team gathered input regarding how drug shortages might be mitigated or prevented from 30 major pharmaceutical companies, global regulators, and industry professionals attending global ISPE conferences held in Frankfurt, Germany, in April 2014 and Baltimore, Maryland in June 2014 as well as other workshops.

The plan is organized around a six-dimension framework, each of which are interlinked: Corporate Quality Culture; Robust Quality System, Metrics; Business Continuity Planning; Communication with Authorities; and Building Capability. The plan addresses optimal organizational strategies, such as aligned governance and communication practices, effective manufacturing and quality systems, and appropriate measures of supply-chain robustness and quality.

ISPE’s Drug Shortage Initiative began in 2012, led by a task force of industry leaders, which began working on ways to better understand the root causes and possible mitigations for drug shortages. As a first step, the ISPE Drug Shortages Team developed an anonymous survey seeking the input of pharmaceutical industry professionals and companies. By design, the ISPE Drug Shortages Team has limited the scope of its work to the technical, scientific, manufacturing, quality and compliance issues associated with a company’s supply chain and related to its ability to source, manufacture, and distribute products that have resulted in drug shortages. Areas of concern include:

  • Insufficient manufacturing capacity, exacerbated by industry consolidation, leading to fewer firms making the product
  • Product quality issues that result in temporary or permanent halting of production
  • Lack of secure, consistent availability of active ingredients, components, containers, or closures of suitable quality, even reagents for quality control tests, which can be exacerbated by the increasing globalization of the supply chain for ingredients and manufacturing
  • Shifts in demand that arise from shortages of another drug – causing a chain reaction of shortages
  • Unexpected market outcomes from new approvals e.g. generic manufacturing capacity does not meet expectations, manufacturer of newly approved entity does not have sufficient capacity to meet market demands.

As a second phase of the Initiative, ISPE developed the Drug Shortages Prevention Plan.

Source: ISPE


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