Quality Assurance Department
General Introduction
The Quality Assurance (QA) Department was established in 2002, responsible for controlling and monitoring all product quality management activities to ensure compliance with current GMP regulations.
Since its inception, the department has proactively built and perfected the Center's GMP documentation system, coordinating with functional departments to uniformly implement compliance, risk control, and quality improvement requirements throughout vaccine and biological production.
Functions and Tasks
Function:
The Quality Assurance Department is a specialized unit under the Center for Research and Production of Vaccines and Biologicals, functioning to monitor and ensure the quality of products manufactured at the Center according to GMP standards.
Tasks:
Monitoring the 8 core functions of the QA system, including:
- Document management
- Release management
- Registration – Licensing
- Validation
- Internal inspection
- Deviation management
- Training
- Change management
Monitoring GMP compliance across all production areas (POLYVAC); approving raw material suppliers for production.
Serving as the primary focal point for NRA-related activities (National Regulatory Authority).
Collecting and processing information on product quality in the market.
Managing and monitoring personnel signatures, ensuring approval processes, recording, and record adjustments comply with GMP regulations.
Managing professional records and the PQS documentation system.
Developing, reviewing, and approving procedures (SOP, SD) and related quality records.
Periodic reporting of quality assurance activity results.
Participating in the GMP Council: coordinating to resolve issues, handle product complaints, and prevent product recall risks.
Perform other tasks as assigned by the Director and Center Leadership.
Coordinating with relevant departments to ensure progress and effectiveness in task fulfillment.
