Disphar’s Quality Assurance Department (QA) is responsible for securing total compliance with all quality requirements regarding the development, manufacturing, analysis and supply of Disphar products. QA qualifies and supervises contract manufacturers and API sources, co-ordinates the technical aspects of products, manages the handling of deviations and complaints and co-ordinates the closure of Technical Agreements between manufacturers and MA-holders of Disphar products.
The Department performs audits of manufacturers and API suppliers, on behalf of Disphar and, if applicable, together with Disphar licensees.
The special Pharmaco-Vigilance Unit within the QA Department is responsible for the management of Adverse Events occurring during clinical trials or after launch of a product. The PV Unit monitors and evaluates the risk profile of Disphar products and compiles PSURs (Periodic Safety Update Reports). Upon request, Disphar licensees can be supported with special PV Services in the areas of Adverse Events management and PSURs.
