Articles tagged with “change-control”

Pharma Quality Agreements: What to Include (Sponsor vs CDMO)

Learn what must be included in a pharma quality agreement. This guide covers key clauses, sponsor vs. CDMO responsibilities, and GMP regulatory requirements fro

60 min read

1/8/2026

quality agreement cdmo gmp pharmaceutical manufacturing fda guidance sponsor vs cdmo change control quality management system contract manufacturing

Deviations, CAPA, and Change Control: A Workflow Guide

Learn the integrated workflow for manufacturing deviations, CAPA, and change control in GMP. This guide covers regulatory requirements and common inspection pit

40 min read

1/6/2026

capa change control manufacturing deviation quality management system gmp root cause analysis regulatory compliance iso 13485