Quality control of drugs during the preparation of therapeutic drugs

According to Circular 30/2021/TT-BYT , the control of drug quality during the preparation of drugs to treat patients at medical examination and treatment establishments is carried out as follows:

Quality control of drugs during the preparation of therapeutic drugs

Quality control of drugs during the preparation of therapeutic drugs (Illustration image)

* For the preparation of drugs from medicinal ingredients in case the drug does not have a free-sale registration number in Vietnam or the drug has a free-sale registration number but has not been supplied or has not been supplied in sufficient quantity for treatment:

- The starting materials used to prepare the drug must be of good quality (with an expiry date, attached with a test certificate and invoices and documents for traceability);

- Packaging materials and printed packages are stored in a separate area and distributed according to the preparation requirements;

- Semi-finished products (if any) waiting for packaging to be labeled for preservation according to regulations to wait for quality inspection before proceeding to the next stages;

- Controlling the drug preparation process, including:

+ Control at the weighing area for medicinal ingredients: before weighing and dispensing raw materials, it is necessary to check environmental conditions in terms of hygiene, temperature, and humidity to ensure that the weighing and dispensing area is clean. clean birth and accurate performance results.

Sterile materials must be weighed and dispensed in a sterile area;

+ Control of dispensing activities: appropriate number of bartenders and take appropriate measures to supervise all operations in the preparation process.

The staff must wear the correct labor protection to conduct the preparation operations, the environment and the dispensing conditions must meet the regulations.

All dispensing equipment must be inspected for cleanliness prior to use, throughout the dispensing period.

All ingredients, semi-finished products, precision equipment, rooms and packaging lines in use must be labeled with the name of the drug being prepared and the batch number of the drug being prepared.

Conduct inspection, control and record all test results during dispensing and control the environment in accordance with the dispensing process.

- Control of labeling and packaging activities: control of direct packaging and pre-printed packages before dispensing, labeling and packaging activities must be mechanically separated to prevent the confusion of products. products and packaging, must arrange a separate and safe storage area for finished products waiting to be allowed to be distributed.

* For drugs prepared from finished drugs, in case of dilution of drug concentrations, mixing of drugs, pre-dividing doses, combining dilution with mixing, dilution with divided doses, transformation for use as required. Treatment requirements:

- Finished drugs, before being put into preparation, must be inspected for sensory quality and have their expiry date;

- Controlling the process of drug preparation, packaging and labeling by one person dispensing and one person performing control.

Circular 30/2021/TT-BYT  takes effect from March 1, 2022.



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