Conditions for personnel and equipment of herbal ingredient processing facilities in Vietnam

Recently, the Ministry of Health of Vietnam has issued the Circular No. 03/2016/TT-BYT on herbal ingredient trading, effective from March 06, 2016.

Điều kiện nhân sự và trang thiết bị đối với cơ sở chế biến dược liệu, Thông tư 03/2016/TT-BYT

 

According to Article 13 of the Circular No. 03/2016/TT-BYT of the Ministry of Health of Vietnam, conditions for personnel of herbal ingredient processing facilities are as follows:

- The person in charge of the processing facility must have at least a bachelor's degree in pharmacy and a pharmaceutical practice certificate as prescribed by law.

- The persons participating in herbal ingredient processing must have at least pharmacist assistant qualifications and regularly receive training in herbal ingredient processing.

Moreover, according to Article 15 of the Circular No. 03/2016/TT-BYT of the Ministry of Health of Vietnam, conditions for equipment of herbal ingredient processing facilities are as follows:

- The processing facility must have adequate equipment serving herbal ingredient processing. Such equipment must be safe for operation, easy to clean and maintain, able to prevent cross-contamination, accumulation of dust and dirt, and negative impacts on product quality. The processing facility must establish and comply with instructions on operating and cleaning equipment.

- The quality inspection area must have devices and equipment suitable for sampling, analysis, calibration, and data processing. Analysis equipment must be suitable for the testing method and satisfy quality inspection requirements of the facility.

Note: Herbal ingredients used for processing must undergo quality inspection according to the standards of Vietnam's pharmacopeia specified in Circular No. 09/2010/TT-BYT dated April 28, 2010 of the Minister of Health on medicine quality management. The facility must keep a log of the quality of herbal ingredients purchased, sold, and unused.

View more details at the Circular No. 03/2016/TT-BYT of the Ministry of Health of Vietnam, issued on January 21, 2016.

Le Vy

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