What are the Responsibilities and Authorities of the GDP Assessment Team?

To be specific, according to the provisions of Article 14 of Circular 03/2018/TT-BYT, the Evaluation Team is responsible for:

- Evaluating all activities of the distribution facility according to the corresponding GDP principles and standards, the updated version of GDP principles and standards, and the current related professional regulations; specifically recording the evaluation contents, detected existing issues, and drafting an evaluation report.- Reporting the evaluation results or explaining the GDP evaluation results report in case the distribution facility disagrees with the contents of the GDP evaluation report.

- Securing all information related to the evaluation and all information related to the drug distribution activities of the distribution facility, except in cases of consent from the distribution facility or upon request from a competent state authority for the purposes of inspection, examination, or investigation.

In addition, the Circular specifically stipulates the powers of the Evaluation Team:

- Inspecting all areas, warehouses, and equipment of the distribution facility and having the right to request inspection of other areas related to the distribution, storage of drugs, and drug materials of the distribution facility;- Requesting the provision of documents related to business activities, quality management, and storage of drugs and drug materials of the distribution facility;- Collecting documents and evidence (photocopying, photographing, video recording) to prove detected existing issues during the evaluation process;- Taking samples of drugs and drug materials for quality inspection according to legal regulations;- Drafting a report and requesting the distribution facility to temporarily suspend part or all distribution activities if severe violations affecting the quality of one or more drug products, materials are discovered during the evaluation process and reporting to the competent authority for official decision-making.

Further reference: Circular 03/2018/TT-BYT which took effect on March 26, 2018.

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE