Healthcare & Pharma Industry
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
Don Carter
October 2, 2026
INSIGHTS
GMP, Quality & Compliance Insights
Practical reads on inspections, quality systems and what FDA is looking for, written by the people who lead the work.
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From the Amicus principals
What we are seeing in inspections, audits and remediation work, and what it means for your quality system.
Healthcare & Pharma Industry
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
Becca Mitchell
March 12, 2026
Healthcare & Pharma Industry
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
Becca Mitchell
March 12, 2026
Healthcare & Pharma Industry
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
Jamie Duncan
October 3, 2024
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