03.08.25 -- Pharmaceutical Online Best Of February

This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.

Addressing systemic cGMP issues requires more than technical fixes. Thoughtfully applied, AI can empower professionals to become "special agents" of quality, equipped with a "license to care."

Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.

It is important to develop robust, reliable processes to safeguard APIs. Explore the best practices to provide patients with the highest quality treatment that meets their therapeutic requirements.

The life sciences industry faces big changes in 2025. Companies must adapt to new regulations, AI, and shifting manufacturing landscapes to stay competitive and drive innovation.