Read, Learn, Innovate: Summer Reading List of Pharmaceutical Engineering® Articles
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are some favorites for your summer reading pleasure on a topic that is always important: supply chain issues.
Drug Shortages: a 30,000 Ft View: Business Continuity Planning for Preventing 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.
Operational Risk Management in Global Supply Scenarios
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.
Pharma Supply Chains: Dramatic Changes Ahead
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.
