GUEST COLUMNISTS

• Why Dilution Gets Tricky: The Role Of Measurement Variability

  Dilution's effects on downstream processes and final formulation is often understated. A statistical framework can quantify measurement uncertainty's impacts.

• Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative

  This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

• The Stepwise Path Lilly Mapped From Paper To Digital Logbooks

  Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

• Minimizing Regulatory Risk For Biologics Manufacturing Changes

  Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.

• Selecting The Right eQMS To Maximize Quality Maturity

  Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

• Do Changes Signal The End Of Biosimilar Regulatory Redundancy?

  First came excitement over the looming patent cliff. Then, FDA and EMA took big swings at what many have called redundant work. Combined, they make a more attractive environment for biosimilar developers.

• FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing

  The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.