Drug and Drug Ingredient Testing

Circular 11 stipulates that testing must be carried out according to the quality standards of drugs, raw materials for making drugs that have been approved and updated.

- In cases where the quality standards of drugs, raw materials for making drugs are not updated, the testing facility shall apply the corresponding pharmacopoeia as per the date of production of the batch of drugs, raw materials for making drugs being tested.- In the case of drugs prepared, formulated at medical examination and treatment facilities, testing is carried out according to the quality standards of drugs formulated and promulgated by the facility.

- The sampling of drugs, raw materials for making drugs for testing is carried out according to regulations.

- After analysis, the competent authority will respond with the results of the analysis and testing of drugs, raw materials for making drugs. This process is conducted as follows:

- The results of the analysis and testing of samples of drugs, raw materials for making drugs are recorded on the test or analysis report.- Within a maximum period of 15 days from the date of receiving the drug samples, the testing facility must respond with the testing and analysis results of the drug samples taken by the quality control agency in the following cases:- Drugs with information on serious adverse reactions;- Drugs of facilities with serious violations of Good Practice compliance;- Drugs taken as supplementary samples.- Within a maximum period of 20 days from the date of receiving the drug samples, the testing facility must respond with the testing and analysis results in the following case:- Drugs that need to be tested before circulation.- Drugs that do not fall under the cases requiring the response of results within a maximum period of 15 days, 30 days.- Within a maximum period of 30 days from the date of receiving the samples of drugs, raw materials for making drugs, the testing facility must respond with the testing and analysis results of the samples in the following cases:- Drugs, raw materials for making drugs with tests that require prolonged testing time;- Drugs, raw materials for making drugs with quality standards that need revalidation or reevaluation of testing results;- Drugs, raw materials for making drugs with suspected composition or quality, requiring the application of testing methods different from those registered in the quality standards;- Drugs, raw materials for making drugs with tests that the testing facility does not have sufficient conditions to perform (e.g., lack of equipment, chemicals, reagents, standards).- In cases where it is not possible to meet the response timeline for analysis and testing results, the testing facility must provide a written explanation with the test or analysis report;- Within 24 hours from the time of issuing the test or analysis report, the testing facility must send the report to the quality control body, the manufacturing facility, the importing facility with drugs/raw materials for making drugs sampled, and the facility from which samples were taken.

Particularly for cases of drug samples, raw materials for making drugs that do not meet quality standards, within 24 hours from the time of issuing the analysis or test report, the testing facility must send an official dispatch informing about the drug sample, raw materials for making drugs that do not meet quality standards, along with the test or analysis report to the Ministry of Health (Drug Administration) in the form of an administrative document and electronic document (scan) to the email address: quanlychatluongthuoc.qld@moh.gov.vn or a message to the phone number of the Drug Administration from the official transaction address or phone number of the testing facility and the Department of Health where the drugs, raw materials for making drugs were sampled.

- For samples of drugs, raw materials for making drugs sent by pharmaceutical business establishments, using establishments, organizations, individuals for analysis, testing, or evaluation of drug quality standards, raw materials for making drugs, the response time for analysis and testing results is agreed upon by the parties.

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

-Thao Uyen-

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