Quality

Sirio operates a comprehensive quality management system that provides structured oversight and control at every stage of product development and manufacturing. Our processes are designed to support product safety, consistency, and traceability throughout the supply chain. Sirio’s quality framework is rooted in its pharmaceutical background and applies standardized procedures across its global operations. All quality-related activities are documented, monitored, and continuously reviewed in line with internal standards and applicable regulations. As of September 30, 2025, Sirio had 223 personnel working in its global quality control team. Quality laboratories across the group are equipped to conduct chemical, physical, and microbiological testing to support quality assurance and quality control activities.

Quality Assurance (QA)

Sirio’s Quality Assurance function focuses on maintaining controlled and documented processes across operations, including:

• Supplier qualification, auditing, and evaluation

• Change control and deviation management

• Process and cleaning validation

• Documentation management

• GMP training

• Self-inspections

• Product Quality Review (PQR)

• Preparation and support for certification and regulatory audits

Quality Control (QC)

Sirio’s Quality Control activities support monitoring and verification throughout the production process to help ensure compliance with defined quality standards, including:

• Raw material testing and release

• Testing and release of finished products

• Microbiological monitoring of production environments and products

• Stability testing

• Monitoring of manufacturing quality processes

• Development and validation of analytical testing methods