Recently, drug quality control and management agencies have inspected and detected a number of violations in drug production and circulation, compliance with drug registration documents and legal regulations in drug production and trading activities.
In order to ensure product safety and quality, strict quality control from input materials, production process to storage, transportation and distribution as well as to prevent the risk of confusion and cross-contamination in the production of pharmaceutical products as well as health protection food products (TPBVSK) produced on licensed pharmaceutical production lines, the Drug Administration of Vietnam requires drug and pharmaceutical ingredient manufacturing facilities to ensure that they maintain compliance 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 production process as well as the TPBVSK production process (if production is carried out on the same licensed drug production line).
The Ministry of Health requires strict control of the origin, quality and raw materials for medicine (illustrative photo)
Pharmaceutical and raw material manufacturing facilities must strictly control the origin, quality and use of pharmaceutical raw materials, ensuring that raw materials put into production are for the right purpose, have the right origin, and are manufactured according to the drug registration dossier and are supplied from raw material manufacturing and distribution facilities that have been fully assessed as suppliers; Pharmaceutical raw materials must be quality tested and meet quality standards according to standards approved by the Ministry of Health in the drug registration dossier before being put into drug production.
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.
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.
Build a comprehensive quality management system, control activities according to GMP, GLP, GSP standards; fully comply with legal regulations in the production and trading of drugs and functional foods (if any).
Strengthen self-inspection and review of compliance with GMP, GLP, GSP and legal regulations during production and business, 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 functional foods. Timely report to the Ministry of Health and local Department of Health when detecting issues related to the quality and safety of products manufactured by the facility.
For the Department of Health of provinces and centrally-run cities, the Drug Administration requires strengthening inspection and supervision of drug manufacturing facilities in the area, especially drug manufacturing facilities that produce health protection foods and cosmetics; Proactively grasp information and inspect compliance with regulations on production, use of raw materials, labeling, advertising... and maintenance of GMP and GSP principles in production and preservation activities. Strictly handle violations according to the provisions of law. If violations are detected, report to the Ministry of Health for timely handling.
According to VOV
Source: https://baothanhhoa.vn/bo-y-te-yeu-cau-kiem-soat-chat-che-nguon-goc-chat-luong-va-nguyen-lieu-lam-thuoc-250873.htm
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