What are requirements on quality system regarding Good Storage Practices for medicinal products and materials in Vietnam?

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

Pursuant to Section 4, 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 quality system regarding Good Storage Practices for medicinal products and materials in Vietnam are as follows:

4.1. There shall be a documented quality policy describing the overall intentions and requirements of the storage facility regarding quality. This policy shall be authorized by management, communicated and understood by all personnel.

4.2. The quality system should include an appropriate organizational structure, procedure, processes and resources and systematic actions necessary to ensure adequate confidence that a product or service and its documentation will satisfy given requirements for quality.

4.3. The quality system should include provisions to ensure that the storage facility, manufacturer, importer, medicine/pharmacy authorities, as well as other relevant competent authorities, would be informed immediately in a case of confirmed or suspected counterfeiting of a medicinal product or medicinal material. Such products should be stored in a secure, segregated area and clearly identified to prevent further distribution or sale.

4.4. Where electronic commerce (e-commerce) is used in one, some or all of operations involving receipt, storage, release, inspection and monitoring of quality, defined procedures and adequate systems should be in place to ensure traceability and confidence in the quality of the medicinal products concerned.

4.5. Storage facilities should adopt regulations and assess suppliers and distributors to ensure that appropriate medicinal products and materials are sourced only from approved suppliers and distributed by approved entities.

4.6. Storage facilities should from time to time conduct risk assessments to assess potential risks to the quality and integrity of medicinal products and materials. The quality system should be developed and implemented to address any potential risks identified. The quality system should be reviewed and revised periodically to address new risks identified during a risk assessment.

Traceability of medicinal products and materials

4.7. There should be regulations in place to ensure document traceability of products received, stored, quarantined, released and returned, to facilitate product recall or other necessary operations.

4.8. There should be records in place to specify information about all facilities involved in the supply, distribution, storage, use and transport of medicinal products and materials, stating at least names and address of such facilities.

4.9. Regulations and measures shall be in place to ensure that each batch has documentation that can be used to permit traceability of the products or define the next route of products.

Above are requirements on quality system 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!