Read, Learn, Innovate: Pharmaceutical Engineering® on Drug Shortages

As noted in the ISPE Drug Shortages Prevention Plan, business continuity planning is a powerful, methodology, essential for enabling an uninterrupted supply of critical medicines for patients in challenging manufacturing circumstances. This “30,000-foot view” article shares an executive summary of principles and best practices of business continuity planning to ensure continued pharmaceutical supply.

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The current regulatory framework in the pharmaceutical industry places pressure on marketing authorization holders (MAHs) to demonstrate quality oversight, and a systematic risk management process is a prerequisite for avoiding compliance and productivity pitfalls. This article focuses on options to improve day-to-day operations and to ease decision-making by integrating operational risk management into a company’s quality system.

Biopharmaceutical supply chains are undergoing dramatic changes that will affect the design and operation of the facilities of the future. Predominant among these is the shift away from primary care to specialty products and personalized medicine, and from large-scale production of low-value small molecules to low-volume, high-value biologics.

Supply chain management. Three simple words, perhaps, but together they constitute an entire process, one that is critical to a contract development and manufacturing organization (CDMO) and its customers. In today’s market, increased regulation, cost pressures, intensifying competition, and globalization present complex challenges to proper management of the pharmaceutical supply chain and are forecast to increase. If drug manufacturers are to deal with these complex dynamics successfully, mastering the process of supply chain management is essential. They must also maintain flexibility, however, and be prepared to react to changes in demand, maintain a secure supply chain, and a produce a consistently high level of quality.