Inspection Team for GDP Compliance at Drug and Pharmaceutical Ingredient Distribution Facilities

To be specific, according to Article 13 of Circular 03/2018/TT-BYT, the evaluation team consists of a Head, a Secretary, and other members as decided by the Director of the Department of Health. The number of evaluation team members must not exceed 05 people.

Evaluation team officials must meet the following standards:

- Be officials and public employees of the Department of Health or officials and public employees, contract staff of units under the Department of Health;- Have a university degree or bachelor's degree or intermediate level in pharmacy or medicine or higher;

- Have been trained in GPP, inspection, evaluation of GPP, and master the principles and standards of GPP;- Be honest, objective, and strictly comply with regulations and legal provisions during the evaluation process, and have no conflict of interest with the evaluated distribution facility;- The Head of the evaluation team must have a university degree in pharmacy or higher and have at least 02 years of experience in pharmaceutical management.

Regarding the principle of conflict of interest evaluation, according to the provisions of Circular 03/2018/TT-BYT, an evaluation team member is considered to have a conflict of interest with the evaluated distribution facility if they fall into one of the following cases:

- Having worked for the evaluated distribution facility within the last 05 years;- Having been involved in consulting activities for the evaluated distribution facility within the last 05 years;- Having financial interests with the evaluated distribution facility;- Having a spouse, children, parents, siblings, parents-in-law, or in-laws working for the evaluated distribution facility.

Circular 03/2018/TT-BYT came into effect on March 26, 2018.

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