Curious Quill·Sep 15Hot Melt Extruder Performance in Solid Dispersion Development: A Lab-Scale PerspectiveOral bioavailability is one of the most persistent challenges in small-molecule drug development. When an active pharmaceutical ingredient…
Mahtab Shardi·Aug 24Can the FDA Inspect a Pharma Site in Toulouse? Here’s How GMP Really WorksWhat happens when a pharmaceutical site in Toulouse manufactures for both Europe and the United States? Which GMP rules actually matter and…A response icon2A response icon2
Mahtab Shardi·Aug 10Pharma Regulation Is Changing Fast in 2026, 7 Shifts Quality Teams Can’t IgnorePharmaceutical regulation in 2026 is changing faster than many quality systems can adapt.A response icon1A response icon1
Mahtab Shardi·Jul 27Most Companies Misunderstand EU GMP Annex 11, Here’s What Inspectors Actually Look ForEU GMP Annex 11 governs computerized systems that support GMP-regulated pharmaceutical work. It covers software and hardware used in…
Mahtab Shardi·Jun 29Reading EU GMP Annex 1 Isn’t Enough, Here’s What Experienced GMP Teams Read Next“I’ve read Annex 1 three times, but I still don’t know how to build a Contamination Control Strategy.”
Mahtab Shardi·Jun 22Why GMP Compliance in 2026 Is No Longer Just a Documentation ProblemIn modern pharmaceutical operations, GMP compliance is often misunderstood as a documentation discipline. In reality, regulators today…A response icon1A response icon1
Mahtab Shardi·Jun 15How QaaS Is Rebuilding GMP Quality Governance in PharmaWhy QaaS Is Quietly Taking Over Quality Ownership in Regulated Pharma SystemsA response icon1A response icon1
Larisa Albanians·Feb 6Why Pharma Plants Struggle to Retain Operational KnowledgeIn pharmaceutical manufacturing, knowledge is not just power — it is compliance, quality, and continuity. Yet across pharma plants…
Larisa Albanians·Feb 4Why Audit Observations Often Repeat in Pharma ManufacturingEvery pharma manufacturing leader has faced this moment: an audit closes; observations are addressed, CAPAs are documented—and yet, during…
