Role of Quality Assurance Within EU and US Pharmaceutical Regulations

EU regulations do not mandate a separate Quality Assurance (QA) department for medicinal product manufacturing, though most companies maintain one. Unlike production, QC or the Qualified Person, the EU GMP guidelines give the QA head no defined responsibilities, mentioning the role only once in Part 1, Chapter 2.9 as sharing duties related to the quality management system.

For active pharmaceutical ingredients, EU GMP Part 2 requires an independent Quality Unit that covers both QA and QC. This reflects industry practice, where QA helps establish and maintain a pharmaceutical quality system ensuring products are safe, effective and compliant with authorisations.

The U.S. FDA distinguishes QC as focusing on material testing and batch release, while QA oversees procedures, records and audits. Together, they form the Quality Unit with authority over the quality system.

ICH Q10 further outlines key system elements such as process monitoring, CAPA, change management and management review. QA supports these functions to ensure continuous GMP compliance.

17-11-2025