Quality Assurance Department

The Quality Assurance (QA) Department is the custodian of Nivix Pharmaceuticals Limited's quality management system. QA ensures that all activities from product development and procurement to manufacturing, testing, storage, and distribution are conducted in accordance with WHO-GMP guidelines, applicable regulations, and the company's own quality policies.

Key responsibilities include document control, batch record review and release, deviation and change control management, CAPA (Corrective and Preventive Action), internal audits, supplier qualification, and training programme oversight. QA maintains the master formula records, SOPs, and specifications that govern every aspect of our operations.

Before any finished product is released for sale, QA conducts a comprehensive review of manufacturing records, analytical results, environmental monitoring data, and packaging documentation. Only when full compliance is confirmed does QA grant batch release — a critical step that safeguards patient safety and regulatory standing.

QA also leads our commitment to continuous improvement. Through trend analysis, management review meetings, and regulatory intelligence, the department identifies opportunities to strengthen processes, reduce risk, and enhance overall quality culture across the organisation.

At Nivix, Quality Assurance is not a checkbox , it is a mindset embedded in every department. Our QA professionals are experienced, independent, and empowered to make decisions that prioritise quality above all else, ensuring that the Nivix name remains synonymous with trust and excellence.