10.11.25 -- Pharmaceutical Online Best Of September

The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation.

Setting up a new facility requires a robust process for environmental monitoring, as well as properly qualified cleanrooms in classified areas. Here are critical considerations to keep in mind.

Learn how early contamination control decisions impact cost and efficiency, as well as expert strategies on facility design, disposables, training, isolators, and CDMO partner evaluation.

Examine the steps of cleaning validation for both low-volume and high-volume manufacturers and the important role these studies play.

Explore the critical role of inspection systems, specifically metal detectors, X-ray systems, and checkweighers, in pharmaceutical manufacturing.

Discover why biological indicators are the gold standard for sterilization validation in manufacturing, as well as how choosing the right one ensures safety, compliance, and product integrity.