What are the specific roles and responsibilities of the Quality Unit/Department in a pharmaceutical wholesale company?

The quality department is the “guardian” responsible for protecting medicine quality, independent of commercial operations such as sales and procurement. Its core responsibility is to ensure that all company activities strictly comply with GDP requirements and the internal Quality Management System. Specifically, the quality department’s responsibilities span the entire operation: it establishes and maintains QMS documentation (such as SOPs); leads or participates in all key quality-related activities, including deviation investigations, change control, CAPA management and internal and external audits; conducts supplier and customer qualification checks; provides GDP training to staff; reviews and approves all quality-related records; makes final decisions on returns, complaints and recalls; and releases finished products to the market. To fulfil these responsibilities, the quality department must be given sufficient authority and resources, and its decisions must not be influenced by commercial interests.