GUEST COLUMNISTS

• All The Ways Global Biopharma Still Grapples With Annex 1

  Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.

• Clearing The Fog On New First Air Visualization Expectations

  Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.

• FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address

  For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework. The public comment period ends May 8.

• Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables

  A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

• Where Contamination Control Really Breaks Down In Practice

  Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

• Trends In FDA FY 2025 Warning Letters

  The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends.

• SUS Interchangeability Assessment And Qualification Best Practices

  Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.