Quality Management Roles and Responsibilities

Quality management has a close relationship with all production, control, technical, procurement, sales, distribution and warehousing activities and is responsible for the quality attitude during the entire operation and uses various tools to achieve this. Quality management includes the following departments and unit:

1.  Regulatory unit

2. Quality Assurance department

3. Quality Control department

The main duties of the integrated regulatory unit include the following:

0. Quality risk assessment in cooperation with the inspection unit
1. Participation in handling complaints and recalls with the inspection unit
2. Follow up of clinical trials
3. Pharmacovigilance (collection, tracking, evaluation and monitoring of side effects of medicinal products)
4. Planning, preparation and submission of PSUR (Periodic Safety Update Report)
5. Participation in inspection, based on GXP principles
6. Update information, according to the latest changes in guidelines and national and international laws
7. Coordination and follow-up of matters related to the registration of biological drugs
8. Tasks assigned by the Authorized person and quality manager