Quality Control Department 1

The Quality Control Department is responsible for organizing and implementing all activities related to testing and quality control during vaccine and biological production and distribution, including:

Planning and Coordination of Testing: develop annual testing plans; approve and monitor the execution of testing items per protocols.

Validation and Quality Management: evaluate trial results, provide written reports to departments, and establish shelf life and storage conditions for products like Polio and Rotavin.

SOP and Technical Dossier Management: draft, review, and update SOPs for testing, validation, calibration, and other technical docs.

Technical Specification Management: develop specs and CoA for raw materials, semi-finished products, and final products.

Analysis and Process Control: monitor testing trends, control process stability, handle deviations, and maintain seed systems (cells, bacteria, Mycoplasma, serum...).

Supplier Qualification: coordinate with relevant departments to approve raw material suppliers.

Equipment and Materials Control: catalog, inspect, and manage equipment under the department's jurisdiction.

GMP Compliance: monitor GMP compliance in all testing activities and ensure proper record storage.

Training and Professional Development: develop training programs, guide and test staff skills/protocols, and organize continuous GMP training.

GMP Council Participation & Issue Handling: resolve arising GMP issues, evaluate product complaints, or handle recall risks.

Activity Reporting: summarize and report periodic quality control results to the Board of Directors.

R&D Participation: participated in epidemiological surveillance, isolation, and production of Rota vaccine since 1998. Rotavin was licensed by the Ministry of Health in 2012 and marketed since then.

Participation in Projects and Other Tasks: execute research projects as assigned by the Director and Center Leadership.