Circular 04/2018/TT-BYT: Responsibilities and Powers of the Assessment Team

To be specific, according to the provisions of Circular 04/2018/TT-BYT, the Assessment Team has the following responsibilities:

- Evaluate the entire activities of the testing facility according to the corresponding GLP principles and standards stipulated in Article 3 of this Circular, the updated version of the GLP principles and standards, and the current relevant specialized regulations; specifically record the evaluation contents, detected non-conformities, make an evaluation record, and a GLP evaluation report;- Report the evaluation results or explain the GLP evaluation results report in case the testing facility disagrees with the contents of the GLP evaluation report;- Keep all information related to the assessment and all information related to the testing activities of the testing facility confidential, except with the consent of the testing facility or upon the request of a competent State agency to serve inspection, examination, or investigation activities.

At the same time, this Circular also stipulates that the Assessment Team has the following powers:

- Inspect all areas and laboratories under the testing facility and have the right to recommend inspecting other areas related to the testing activities of the testing facility;- Request the provision of records and documents related to the business activities, quality management, and testing activities of the testing facility;- Collect documentary evidence (photocopies, photos, videos) of detected non-conformities during the assessment process;- Take samples of drugs and drug raw materials to send for quality testing according to legal regulations;- Make a record and request the testing facility to temporarily suspend one or several sections or the entire testing activities related to violations, if during the assessment process, the Assessment Team detects that the testing facility has violations that seriously affect the accuracy of the analysis results; report to the competent person for official handling decision.

See more: Circular 04/2018/TT-BYT effective March 26, 2018.

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE