The Ministry of Health requires strengthening compliance with GMP and inspection and supervision of drug production activities.

The Drug Administration of Vietnam ( Ministry of Health ) has issued specific requirements to ensure product safety and quality, strict quality control from input materials, production process to storage, transportation and distribution as well as prevention of the risk of confusion and cross-contamination in production for pharmaceutical products as well as health food products produced on licensed pharmaceutical production lines.

For drug and pharmaceutical ingredient manufacturing facilities, it is necessary to ensure that they maintain compliance with and strictly comply with the principles and standards of "Good Manufacturing Practice" (GMP) in accordance with the regulations of the Ministry of Health throughout the drug manufacturing process as well as the health food manufacturing process (if manufacturing is carried out on the same licensed drug production line); strictly control the origin, quality and use of drug ingredients, ensure that the ingredients put into production are for the right purpose, have the right origin, and are manufactured according to the drug circulation registration dossier and are supplied from the raw material manufacturing and distribution facilities whose suppliers have been fully assessed.

Pharmaceutical ingredients must be quality tested and meet quality standards according to standards approved by the Ministry of Health in the Drug Circulation Registration File before being put into drug production.

Units review production processes, production records, testing records, ensure compliance with production processes, quality control processes according to approved and assessed drug registration records, as well as fully implement regulations on drug registration.

In case of changes in the production process, quality standards, and analysis process to ensure the feasibility, correctness, and accuracy of the method, the change procedures must be promptly carried out according to the regulations on drug registration, and can only be implemented after being reviewed and accepted by the Ministry of Health (Department of Drug Administration) according to regulations.

Production facilities must establish a comprehensive quality management system, control operations in accordance with GMP, GLP, GSP standards; fully comply with legal regulations in the production and trading of drugs and protective foods (if any).

At the same time, strengthen self-inspection and review of compliance with GMP, GLP, GSP and legal regulations in the production and business process, promptly detect and correct errors and be responsible before the law and management agencies for the quality and safety of products manufactured by the facility, including pharmaceutical products and health food products.

The Drug Administration also requested the Department of Health of provinces and cities to strengthen inspection and supervision of drug manufacturing facilities in the area, especially drug manufacturing facilities that produce health protection food products and cosmetics; proactively collect information and check compliance with regulations on production, use of raw materials, labeling, advertising, etc. and the maintenance of GMP and GSP principles in production and preservation activities.

Thanh Mai

Source: https://nhandan.vn/bo-y-te-yeu-cau-tang-cuong-tuan-thu-gmp-va-kiem-tra-giam-sat-hoat-dong-san-xuat-thuoc-post884285.html