Requested by the EMA (European Medicines Agency) in 2013, the plan focuses on six “dimensions,” including the development of a corporate quality culture, robust quality systems management, metrics, business continuity planning, communication with authorities and building capability.
“The root causes of drug shortages are many and often involve a trigger in production factors or technical processes that can set into motion a cause-and-effect chain that can lead to a shortage,” the ISPE says.
Creating a robust quality system must involve managing key tools such as corrective and preventive action (CAPA) plans endorsed by senior management, according to the plan.
As equipment failures often lead to product interruptions, ISPE recommends preventive maintenance plans for facilities and equipment used in pharma manufacturing. “All this should be embedded in a Pharmaceutical Product Life Cycle management in the sense of continual improvement as outlined in ICH Q10, ‘The Pharmaceutical Quality System,’ for all marketed products including legacy products,” ISPE says.
ICH is mentioned multiple times throughout preview of the plan, especially ICH Q10 , which deals with quality systems.
In addition, the plan leverages a 2013 ISPE survey of manufacturers that revealed metrics used to track shortages should be well-defined and help mitigate them. Metrics should also identify and allow mitigation, monitor the supply chain, be able to predict actual shortages in terms of scope, duration and patient impact, and demonstrate corrective action. The plan was developed by the ISPE Drug Shortages Task Team which built upon the results of ISPE’s study on drug shortages and engaged with leaders from more than 30 major pharmaceutical companies.
Quality system issues contributed to about one quarter of all drug shortages, according to the survey of more than 200 respondents. Manufacturing issues are responsible for 75% of all shortages, the US FDA told us.
Case studies in the plan will also offer an inside look at how companies were able to mitigate shortages. One such study centers on a major excipient supplier that when consolidating its manufacturing and supply sites realized that one of its sites was supplying one-fifth of the market. Other studies deal with what companies do when they face problems with their CMOs (contract manufacturing organizations), as well as when contamination issues arise.
“Our goal is that the pharmaceutical industry will use the Plan to not only help them look holistically across the supply chain, but also as a roadmap to use in challenging their current processes, systems and practices and to identify potential gaps and risks,” said ISPE CEO and President, Nancy Berg.