Why Equipment Qualification Matters Before Production
A machine can power on, pass a dry run, and still fail when real product hits the line. Within the pharmaceutical industry and the broader life sciences sector, equipment qualification serves as the documented proof that systems are installed correctly, operate within defined limits, and remain reliable over time. This process is vital for medical […]
Novo Nordisk and Hims & Hers Partner to Expand Access to GLP-1 Treatments
Novo Nordisk and Hims & Hers are partnering to widen access to branded GLP-1 treatments, shifting demand away from compounded products. What it means for compounders and clinical sponsors.
FDA Inspection Trends Highlight Ongoing Quality System Weaknesses
Recent comments from an FDA investigator point to the same recurring Form 483 themes: quality unit oversight, procedures not followed, and investigations that do not close the loop.
Preparing for an FDA Audit
In FDA-regulated industries, the stakes are high when it comes to complying with Good Manufacturing Practices (GMP). For pharmaceutical manufacturers and 503B outsourcing facilities, navigating an FDA inspection can make or break your business. Amicus understands this better than anyone. A successful FDA inspection keeps your facilities running efficiently, improves patient safety, and boosts your […]