Vietnam: Contents of records of each processing batch of herbal ingredient

According to Article 20 of the Circular No. 03/2016/TT-BYT of the Ministry of Health of Vietnam, the records of each processing batch must specify:

- Name and quantity of products;

- Processing date, batch number;

- Full formula of the batch;

- Standard operating procedures (SOPs) of each stage;

- Standard operating procedure for operating and cleaning primary equipment;

- All samples and inspection results obtained during the processing, result of environmental condition inspection and equipment inspection before and during the processing, packaging, and labeling on the final packages.

It is required to have records on every raw materials and additives used, SOPs, each batch and shipment; equipment including operation, cleaning, maintenance, and inspection; records on cleaning works, maintenance, and environment control of the processing area.

Notably, every record must have a date, bear the signature of the responsible person, and be retained at the facility until the expiration date of products.

Moreover, finished products (processed herbal ingredients) must be preserved in the finished product warehouse which satisfies all conditions specified in Clause 2 and Clause 3 Article 9 of Circular No. 03/2016/TT-BYT. The minimum area of the finished product warehouse is 200m2, minimum volume 600 m3.

Concurrently, the processing facility must apply facility hygiene and personal hygiene principle throughout the processing of herbal ingredients, including hygiene of the building, personal hygiene, hygiene of machinery, equipment and packages. Hygienic requirements and hygiene conditions specified in Article 6 of Circular No. 16/2011/TT-BYT dated April 19, 2011 of the Minister of Health on rules for manufacturing of herbal medicines and roadmap for applying GMP to manufacturers of herbal medicines.

View more details at the Circular No. 03/2016/TT-BYT of the Ministry of Health of Vietnam, issued on January 21, 2016.

Le Vy

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