Deputy Health Minister Do Xuan Tuyen has just signed Decision 3155/QD-BYT promulgating a plan to inspect the health sector in 2023 to assess the implementation of legal provisions in the health sector to promptly detect preventable diseases. prevent and handle violations. For the field of manufacturing pharmaceuticals, cosmetics, and medical equipment: Health sector inspection includes the implementation of legal provisions on drug quality management, drug management subject to special control and bidding, procurement of drugs, equipment, and medical supplies; trading in pharmaceutical materials; …
In Vietnam, pharmaceutical manufacturing enterprises must comply with GMP WHO standards according to the guidance from the Decision No. 3888/QD-BYT of the Minister of Health issued on November 31, 2004, on the application. principles and standards of “good manufacturing practice” as the World Health Organization recommended.
GMP standards or good manufacturing practices (GMP) in pharmaceutical manufacturing require manufacturers to ensure:
About personnel: arrange the standard of working positions to match the capacity and qualifications of the personnel. At the same time, it is necessary to develop strict regulations on health checks, including items such as intelligence, physical strength, and illness of all personnel, straightforward production workers.
Regarding the design, construction, and installation of houses, workshops, and processing machinery and equipment: there are clear regulations on the location of factory construction and installation of processing equipment.
Regarding the requirements for control of factory hygiene and environment: focus on input water, treatment of output wastewater, and treatment of by-products and waste to ensure environmental and factory hygiene.
Regarding processing control requirements: strictly implementing regulations on processing methods, procedures, specific work instructions, ensuring standards of ingredients and recipes, and products. In addition, it is also necessary to have measures to monitor and control the drug production process.
Regarding the requirements on the control of the product preservation and distribution process: preserving and transporting finished products without contamination, being affected by chemical, physical, and microbiological agents, without changing the quality, …
Pharmaceutical products need to be produced in a clean room to meet the above requirements. Cleanroom is built with perfect control of temperature, humidity, and pressure, in a clean room environment, all factors affecting the production process are strictly controlled. In pharmaceutical manufacturing plants, it is necessary to equip HEPA filters and moisture treatment systems to ensure the environment is free of moisture and contamination.
VAF™️ - VIET AIR FILTER, a Vietnamese enterprise specializing in the production of HEPA filters, clean room equipment, design consulting, and clean room construction with a journey of 15 years of experience, we continuously develop in scale, technology technology, production process to meet all requirements from domestic and international customers.
If you have any need for a survey, clean room consulting, or need advice on good manufacturing practice (GMP) clean room construction, please contact us at hotline: 1900 8949
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