What are requirements on design and construction of the warehouse regarding Good Storage Practices for medicinal products and materials in Vietnam?

What are requirements on design and construction of the warehouse regarding Good Storage Practices for medicinal products and materials in Vietnam? - image from internet

Pursuant to Section 3, Appendix II issued together with the Circular 36/2018/TT-BYT on Good Storage Practices for medicinal products and materials, which is promulgated by the Ministry of Health, the requirements on design and construction of the warehouse regarding Good Storage Practices for medicinal products and materials in Vietnam are as follows:

3.1. The warehouse should have a sufficient area which is suitable for the scope of business in order to allow the orderly storage of the various categories of products. A warehouse must be wide enough to create space for the following operations:

- Receipt, inspection of receipt and cleaning of containers;

- Inspection and control of quality of herbal medicinal materials and traditional ingredients;

- Sample collection, handling of sampling tools;

- Storage of herbal medicinal materials and traditional ingredients;

- Storage of toxic herbal medicinal materials and traditional ingredients;

- Quarantine of products awaiting handling (in case products are returned, recalled or suspected to be counterfeit or any doubt arises over their quality, etc.)

- Quarantine of rejected goods prior to their disposal;

- Shipment containers and container labeling;

- Release;

- Storage of packaging materials;

- Storage of equipment and tools serving loading, unloading and movement;

- Change of clothes, storage of protective garments and warehouse office.

3.2. The minimum area and minimum volume of an importer of herbal medicinal materials and traditional ingredients or provider of herbal medicinal material and traditional ingredient storage services should be at least 500 m2 and 1.500 m3 respectively.

3.3. The reception area, receipt inspection area, area for storage of herbal medicinal materials and area for storage of traditional ingredients should be isolated from other areas to avoid cross-contamination and dust.

Roads in areas should allow movement in only one direction in accordance with the diagram of location and design of the warehouse.

3.4. Sampling areas should be suitably designed and provided with equipment to ensure sampling.

3.5. Areas of the warehouse should have signs clearly indicating capacity of each area, have appropriate size and volume and provide enough space to allow categorization and arrangement of herbal medicinal materials and traditional ingredients.

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

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

3.8. The ground of a warehouse must be adequately elevated, flat, smooth and hard, and able to withstand the impact of underground water to ensure smooth operations carried out by employees working therein and easy movement of vehicles. There should be no cracks which are places for dust and insects'

Above are requirements on design and construction of the warehouse regarding Good Storage Practices for medicinal products and materials in Vietnam. Please refer to the Circular 36/2018/TT-BYT for further information.

Best regards!