Documentation and Testing Templates for Quality Assessment of Vaccines

According to Circular 11, vaccines and biologics that are serums containing antibodies, blood derivatives, and human plasma produced domestically, the production facility must send production dossiers and samples of the product batch (finished products, semi-finished products) to the National Institute for Control of Vaccines and Biologicals.

The dossier includes:

- Sample submission form for testing;- Vaccine and biological samples for testing (the quantity of samples for each type of vaccine and biological as stipulated in the Guidance on factory release testing of vaccines and biologics that are serums containing antibodies, blood derivatives, and human plasma);- Summary dossier of production and quality control of vaccine and biological batches (copy with the facility’s certification seal);- Batch testing report from the production facility.

For vaccines and biologics that are serums containing antibodies, blood derivatives, and human plasma imported, the importing entity must send production dossiers and samples of the product batch to the National Institute for Control of Vaccines and Biologicals.

The dossier includes:

- Sample submission form for testing;- Vaccine and biological samples for testing (the quantity of samples for each type of vaccine and biological as stipulated in the Guidance on factory release testing of vaccines and biologics that are serums containing antibodies, blood derivatives, and human plasma);- Summary dossier of production and quality control of imported vaccine and biological batches (copy with the facility’s certification seal of the production facility or the importing facility);- Quality certificate from the competent authority of the exporting country for each batch of imported vaccines and biologics (copy with the importing facility’s certification seal);- Data log on storage conditions (cold chain) during the transportation of the imported batch (certified by the importing facility) from temperature recording devices, and freeze indicators (if any).

Particularly, the production facility and the importing facility must be responsible for the legality of the documents provided by the facility.

See details in Circular 11/2018/TT-BYT effective from June 20, 2018.

-Thao Uyen-

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