Storage Conditions for Drugs and Active Pharmaceutical Ingredients in Non-Commercial Establishments in Vietnam
What are storage conditions for drugs and active pharmaceutical ingredients in non-commercial establishments in Vietnam? Thank you!
Minh Thanh - Ben Tre
Storage Conditions for Drugs and Active Pharmaceutical Ingredients in Non-Commercial Establishments in Vietnam - Image from Internet
Section 3 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 storage conditions for drugs and active pharmaceutical ingredients in non-commercial establishments in Vietnam:
3.13. Storage conditions for drugs and active pharmaceutical ingredients must comply with the information on the approved or published label.
Unless there are other special requirements (for example, maintaining continuous cold storage), only storage outside of the above regulations is accepted for short periods of time, for example, when transporting locally in the warehouse.
3.14. Guidelines for storage conditions:
a) Normal storage conditions:
Store in a dry environment (humidity 75%), at a temperature of 15-30°C. In extreme weather conditions, at certain times of the day, the temperature may be above 30°C but not exceeding 32°C and the humidity not exceeding 80%.
Must be well-ventilated, avoid the effects of odors, contaminants, and strong light.
If the label does not specify storage conditions, store under normal conditions.
b) Special storage conditions: Includes cases with storage requirements other than normal storage.
c) Guidelines for specific storage conditions:
|
Information on the Label |
Storage conditions |
|
Do not store above 30 °C |
From +2 °C to +30 °C |
|
Do not store above 25 °C |
From +2 °C to +25 °C |
|
Do not store above 15 °C |
From +2 °C to +15 °C |
|
Do not store above 8 °C |
From +2 °C to +8 °C |
|
Do not store under 8 °C |
From +8 °C to +25 °C |
|
Store in a refrigerator |
From +2 °C to +8 °C |
|
Store in a cool place |
From +8 °C to +15 °C |
|
Dry |
Not more than 75% relative humidity in normal storage conditions; or if packaged in a waterproof container until reaching the patient. |
|
Keep out of direct sunlight |
Store in light-resistant packaging until reaching the patient. |
3.15. Storage conditions are checked at appropriate predetermined times (at least 2 times/day). The results of the inspection must be recorded and archived. Records of the data tracking of storage conditions must be available for reference.
3.16. Storage monitoring devices during storage and during transportation must be placed in areas/locations with the greatest potential for fluctuation, as determined based on the results of the temperature uniformity assessment in the warehouse.
Each warehouse or warehouse area (in the event that the warehouse areas have a physical separation and have a separate air conditioning system) must be equipped with at least 1 temperature monitoring device capable of automatically recording the temperature data monitored with a suitable recording frequency (at least 30 minutes/time). The automatic recording device must be placed in the position with the highest risk based on the results of the temperature uniformity assessment.
For drugs and drug ingredients with special storage requirements (e.g., vaccines, biological products), special condition monitoring devices (e.g., temperature) must be used continuously during storage and transportation. The use of the monitoring device and the data recorded must be retained.
3.17. The assessment of temperature uniformity in the warehouse must be carried out according to the principles set out in the World Health Organization's Guidelines for Assessing Temperature Uniformity of Storage Areas (Temperature mapping of storage areas). The results of the temperature uniformity assessment must show uniformity in temperature throughout the entire storage warehouse.
Above are storage conditions for drugs and active pharmaceutical ingredients in non-commercial establishments in Vietnam. Please refer to the Circular 36/2018/TT-BYT for further information.
Best regards!
