Pharmaceutical and pharmaceutical ingredient manufacturing facilities must comply with GMP.
Strict control from input materials
According to Mr. Ta Manh Hung, Deputy Director of the Department of Drug Administration, Ministry of Health , recently, drug management and quality control 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.
Therefore, strict quality control from input materials, production process to storage, transportation and distribution as well as preventing the risk of confusion in the production of pharmaceutical products and health protection food products (TPBVSK) is very important.
A representative of the Drug Administration Department said that for drug and pharmaceutical ingredient manufacturing facilities, they must ensure that they maintain compliance with and strictly comply with GMP principles and standards in accordance with the regulations of the Ministry of Health throughout the drug manufacturing process as well as the health food manufacturing process (if production is carried out on the same permitted drug production line).
At the same time, strictly control the origin, quality and use of pharmaceutical ingredients, ensure that 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 raw material production and distribution facilities that have been fully assessed as suppliers.
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.
Drug manufacturing facilities must also review their production processes, production records, and testing records, ensuring compliance with production processes and quality control processes in accordance with approved and assessed drug registration records, as well as fully comply with 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 according to regulations.
Building a comprehensive quality management system
The Drug Administration also requires drug manufacturing facilities to build a comprehensive quality management system, control activities in accordance with 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 health food products. 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.
The Department of Health of provinces and centrally run cities is responsible for proactively strengthening inspection and examination of drug manufacturing establishments in the area, especially those that simultaneously produce health protection foods and cosmetics. The inspection content includes compliance with regulations in production, use of raw materials, labeling, advertising and maintenance of GMP and GSP standards in production and storage activities.
Strengthening supervision and raising GMP compliance requirements to regulate drug production activities also contributes to protecting public health, avoiding the risk of using poor quality drugs and health protection foods.
Hien Minh
Source: https://baochinhphu.vn/siet-chat-giam-sat-viec-san-xuat-thuoc-thong-qua-nguyen-tac-gmp-102250603174015884.htm
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