Vietnam’s Circular 03: "Good storage practice" (GSP) applied to herbal ingredients

According to Article 9 of the Circular No. 03/2016/TT-BYT of the Ministry of Health of Vietnam, "Good storage practice" (GSP) applied to herbal ingredients is as follows:

Personnel of the warehouse:

- The warehouse keeper must have an associate degree in pharmacy or above.

- There are adequate workers whose qualifications are suitable for their jobs, one of which has a pharmacist assistance's qualification or above.

- All workers are provided with regular training in professional knowledge and new regulations on preservation and management of herbal ingredients.

Location of the warehouse:

- The warehouse is built at a dry, airy and safe place, has a drainage system , and ensures that herbal ingredients are protected from underground water, heavy rain, and flood.

- The warehouse has a fixed address and its location is convenient for delivery of herbal ingredients.

Design and construction of the warehouse:

- The warehouse must have a sufficient area which is suitable for the scope of business in order to preserve various products orderly. The minimum area is 300 m2, the minimum volume is 1,000 m3. From January 01, 2016, the minimum area is 500 m2 and minimum volume 1,500 m3 (only applied during re-inspection if a GSP certificate is already obtained), including: reception area, area for storage of raw herbal ingredients, area for storage of processed herbal ingredients; intermediate storage area; and area for storage of toxic herbal ingredients.

- The intermediate storage area and the area for storage of raw herbal ingredients must be isolated from other areas in order to avoid cross-contamination and dust.

- Storage areas must be able to prevent insects, rodents, and other animals; prevent the development of molds and fungi, termites, and cross-contamination.

- The ceiling, walls, and roof of the warehouse must be sturdy, airy, and able to withstand weather impacts such as sunlight, rain, storm, flood.

- The ground of the warehouse must be adequately elevated, flat, smooth, and hard, and able to withstand the impact of underground water, ensure that vehicles can easily move, and not have cracks which are places for dust and insects.

Moreover, sanitary equipment shall comply with requirements specified in Section 2.3, Section 3 Part 2 of the Appendix enclosed with Decision No. 2701/2001/QD-BYT dated June 29, 2011 on application of GSP.

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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