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Strictly control the quality standards of pharmaceutical ingredients

On June 3, the Drug Administration of Vietnam (Ministry of Health) sent an official dispatch to the health departments of provinces and cities and drug manufacturing facilities regarding strengthening compliance with "Good Manufacturing Practices" (GMP) standards and inspecting and supervising production activities at drug manufacturing facilities.

Báo Sài Gòn Giải phóngBáo Sài Gòn Giải phóng03/06/2025

Accordingly, the Drug Administration of Vietnam stated that for drug manufacturing facilities, the requirement for drug ingredients must ensure that they meet and strictly comply with GMP principles and standards in accordance with the regulations of the Ministry of Health throughout the process of manufacturing drugs and health protection foods (if permitted to be produced on the same drug production line). In particular, drug ingredients must be quality tested and meet quality standards according to standards approved by the Ministry of Health in the drug circulation registration dossier before being put into drug production.

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The Ministry of Health requires drug manufacturing facilities to strictly control the quality of raw materials. Illustrative photo

At the same time, facilities must review the production process, production records, testing records, ensure compliance with the production process, quality control process according to the approved and assessed drug registration records, as well as fully implement the regulations on drug registration; strengthen self-inspection, review compliance with standards 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 protection food products.

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Drug manufacturing facilities must ensure GMP standards. Illustrative photo

For the health departments of provinces and cities, it is necessary 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 grasp information and check compliance with regulations on the use of raw materials, labeling, advertising and the maintenance of GMP principles in production and preservation activities; strictly handle violations.

Source: https://www.sggp.org.vn/kiem-soat-chat-che-tieu-chuan-chat-luong-nguyen-lieu-lam-thuoc-post797955.html


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