Requirements for Facilities and Equipment in Good Storage Practices for Drugs in Non-Commercial Establishments in Vietnam

Requirements for Facilities and Equipment in Good Storage Practices for Drugs in Non-Commercial Establishments in Vietnam - Image from Internet

Section 2 Appendix III of the Circular 36/2018/TT-BYT on Good Storage Practices for Pharmaceutical Products and Active Pharmaceutical Ingredients, issued by the Minister of Health, specifies the requirements for facilities and equipment in good storage practices for drugs in non-commercial establishments in Vietnam:

2.1. The warehouse must be built in a safe, dry place, and must have a drainage system to ensure that drugs and active pharmaceutical ingredients are not affected by groundwater, heavy rain, or flooding.

The warehouse must have a specific address and a wide enough public or internal transportation system to facilitate transportation, loading and unloading, security, and fire prevention and fighting.

2.2. The warehouse must be designed, built, equipped, repaired, and maintained in a systematic manner to protect drugs and active pharmaceutical ingredients from potential adverse effects, such as: changes in temperature and humidity, waste and odor, animals, insects, and rodents, and to ensure the quality of drugs and active pharmaceutical ingredients.

The roof, walls, and ceiling of the warehouse must be designed and built to ensure ventilation, air circulation, and resistance to weather conditions such as sun, rain, and storms.

The warehouse floor must be high enough, flat, smooth, strong, and treated to prevent groundwater, ensure the safety of employees working in the warehouse, and allow the movement of vehicles. There should be no cracks or gaps that can accumulate dust or serve as a haven for insects and rodents.

2.3 The storage warehouse must be large enough to accommodate areas for the following activities:

- Receiving, inspecting, and cleaning the packaging of drugs and active pharmaceutical ingredients;

- Quarantine (drugs and active pharmaceutical ingredients after receiving for inspection and quality control);

- Inspection and quality control of drugs and active pharmaceutical ingredients for entry into the warehouse;

- Sampling of raw materials and processing of sampling equipment;

- Storage of drugs and active pharmaceutical ingredients;

- Storage of drugs and active pharmaceutical ingredients requiring special storage conditions;

- Storage of drugs and active pharmaceutical ingredients that are subject to special control or must be stored separately;

- Quarantine of goods awaiting processing (returned goods, recalled goods, goods suspected of being counterfeit, goods of doubtful quality, etc.);

- Quarantine of drugs and active pharmaceutical ingredients that have been rejected before disposal;

- Storage of drugs and active pharmaceutical ingredients that have been released from the warehouse awaiting transportation;

- Packaging, transportation, and labeling of drug and active pharmaceutical ingredient shipping containers;

- Release from the warehouse;

- Storage of packaging materials;

- Storage of equipment and tools for loading, unloading, and moving;

- Changing clothes, storing personal protective equipment, and warehouse office;

2.4 The areas of the warehouse must be clearly marked with signs indicating the function of each area, must be of appropriate size and volume, and must have enough space to allow for the classification, arrangement of goods according to different types of drugs and raw materials; separate according to type and lot of drugs and active pharmaceutical ingredients, ensuring that air circulates evenly.

If necessary, the location and area between the areas of the warehouse can be adjusted to suit the storage activities at the warehouse, but must ensure the maintenance of the required storage conditions.

2.5 The storage areas must be designed or adjusted to ensure the required storage conditions and be easy to clean.

2.6 The raw material sampling area must be designed and equipped to meet the requirements for the raw material sampling area at Circular 35/2018/TT-BYT dated November 22, 2018 of the Ministry of Health on Good Manufacturing Practices for Drugs and Active Pharmaceutical Ingredients.

2.7 The warehouse for storing products with the risk of fire and explosion (such as flammable and combustible liquids and solids; compressed gases, etc.) must be designed, built for the storage of flammable products in accordance with the law, must be far from other warehouses and from residential areas. The warehouse must be well-ventilated and equipped with explosion-proof lights. The electrical switches must be placed outside the warehouse.

2.8 Appropriate equipment must be provided to ensure storage conditions (for example: fans, air conditioners, thermometers, forklifts, trucks, hygrometers, cold rooms, refrigerators, vaccine temperature indicators, electronic freezing indicators (Freeze Tag), etc.). The equipment must be inspected, maintained, and serviced regularly to ensure stable and accurate operation. Measuring instruments must be calibrated regularly in accordance with the law on inspection and calibration of measuring instruments.

2.9 There must be automatic detection and warning devices (such as bells, lights, and/or text messages) to promptly notify of accidents or deviations in storage conditions, especially for drugs with special storage requirements (temperature, humidity).

2.10 The warehouse must be sufficiently lit to allow all activities in the warehouse area to be carried out accurately and safely.

2.11. There must be sufficient equipment, shelves, and racks for storing goods. The distance between the shelves, racks, and the warehouse floor must be wide enough to allow for warehouse cleaning, inspection, comparison, and loading and unloading of goods.

The shelf and pallet systems must be kept clean, regularly maintained, and coded to be able to identify the location of goods in the warehouse.

2.12. There must be a computer with internet access and a computer software system for managing drug and active pharmaceutical ingredient storage activities. There must be a mechanism for connecting information from the activities of importing, exporting, and distributing drugs and active pharmaceutical ingredients to customers; information on the quality of drugs and active pharmaceutical ingredients from manufacturers and customers, as well as the transfer of information to relevant regulatory authorities when required.

2.13. There must be sufficient fire prevention and fighting equipment and necessary instructions for fire prevention and suppression, such as: an automatic fire extinguishing system, or fire extinguishers, sand buckets, a water system, and fire hoses.

2.14. The storage areas must be dry, clean, and free of accumulated garbage and insects; they must be protected from odors, contaminants, and strong light.

2.15. Handwashing areas and restrooms must be well-ventilated and properly located (isolated from the areas of drug reception, storage, and processing).

2.16. There must be a regulation governing access to the warehouse area, and there must be preventive measures to prevent unauthorized persons from entering.

2.17. Sufficient lighting must be provided for the storage areas to allow all activities to be carried out accurately and safely. Direct sunlight must not be allowed to shine on drugs and active pharmaceutical ingredients.

Above are requirements for facilities and equipment in good storage practices for drugs in non-commercial establishments in Vietnam. Please refer to the Circular 36/2018/TT-BYT for further information.

Best regards!