Abstract

QUALITY SYSTEM REVIEW, IMPLEMENTATION, AND MONITORING OF COMPLIANCE WITH EU REGULATIONS

*Ms. Sanjeevani Rupwate, Dr. Rahul Khaire

ABSTRACT

Quality Management Systems (QMS) are central to ensuring regulatory compliance in industries governed by European Union (EU) legislation, particularly pharmaceuticals and medical devices. The EU regulatory framework—comprising EU-GMP, EU-GDP, and the Medical Device Regulation (EU 2017/745)—requires organizations to implement structured systems ensuring product quality, safety, traceability, and continuous improvement. This examines the design, implementation, review, and monitoring of QMS in alignment with EU regulatory expectations. It emphasizes risk-based thinking (ICH Q9), quality by design principles, documentation control, deviation management, and corrective and preventive actions (CAPA). The study also evaluates audit systems, data integrity principles (ALCOA+), and performance monitoring tools such as KPIs and quality metrics. Findings indicate that organizations with mature QMS frameworks demonstrate improved regulatory inspection outcomes, reduced deviations, and enhanced operational efficiency. However, challenges such as regulatory complexity, documentation burden, and digital transformation gaps persist.

Keywords: EU-GMP, MDR, Quality Management System, CAPA, Compliance, ISO 13485, Risk Management.