What are requirements on receipt of incoming medicinal products and materials regarding Good Storage Practices for medicinal products and materials in Vietnam?

What are requirements on receipt of incoming medicinal products and materials regarding Good Storage Practices for medicinal products and materials in Vietnam? - image from internet

Pursuant to Section 7, Appendix I 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 receipt of incoming medicinal products and materials regarding Good Storage Practices for medicinal products and materials in Vietnam are as follows:

7.1. On receipt, each incoming delivery should be checked against the relevant purchase order and each container physically verified, e.g. by the label description, batch number, type of medicinal product or material and quantity.

7.2. The consignment should be examined for uniformity of the containers and, if necessary, should be subdivided according to the supplier’s batch number.

7.3. Each container should be carefully inspected for possible contamination, tampering and damage, and any suspect containers or, if necessary, the entire delivery should be quarantined for further investigation. Where possible, this should be brought to the attention of the person responsible for quality control. Any action taken should be documented.

All containers of medicinal products and materials that are damaged, have lost their seals or are suspected of contamination should not be received. If not destroyed immediately, they should be stored in quarantine areas and should not be sold or mixed up with other medicinal products and materials.

7.4. When required, samples should be taken only by appropriately trained and qualified personnel in accordance with the Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Ministry of Health and in strict accordance with written sampling instructions. Containers from which samples have been taken should be labeled accordingly.

7.5. Following sampling, the goods should be subject to quarantine. Batch segregation should be maintained during quarantine and all subsequent storage.

7.6. Medicinal products and materials should remain in quarantine until an authorized release or rejection is obtained.

7.7. Measures should be taken to ensure that rejected medicinal products and materials cannot be used. They should be stored separately from other medicinal products and materials while awaiting destruction or return to the supplier.

Above are requirements on receipt of incoming medicinal products and materials 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!