Inspection Team for Good Laboratory Practices

To be specific, according to Article 13 of Circular 04/2018/TT-BYT, the regulations on the Laboratory Good Practice Evaluation Team are as follows:

* Composition of the Evaluation Team includes:

- Team Leader, Secretary from the Drug Administration Department;- A maximum of 02 members representing the National Institute of Drug Quality Control or the Central Pharmaceutical Testing Institute in Ho Chi Minh City or the National Institute for Testing of Vaccines and Biologicals (for vaccine and biological testing facilities);- 01 member representing the Department of Health of the province or city under central authority where the testing facility is located.

* Standards for officials participating in the Evaluation Team include:

- Holding a university degree or higher, trained in medical, pharmaceutical, biological, or chemical sciences with experience in experimental analysis, inspection, quality management of drugs, and pharmaceutical management;- Trained and instructed in GLP, and familiar with GLP principles and standards;- Honest, objective, and strictly abide by the regulations and legal provisions during the evaluation process, with no conflict of interest with the evaluated testing facility as stipulated in Clause 3 of this Article;- The Evaluation Team Leader must have a university degree in pharmacy or biology, chemistry, or higher, with more than 02 years of experience in pharmaceutical management.

* Principles for evaluating conflicts of interest:

- A member of the Evaluation Team is considered to have a conflict of interest with the evaluated testing facility if they fall into one of the following cases:- Worked during the past 05 years for the evaluated testing facility;- Participated in consulting activities during the past 05 years for the evaluated testing facility;- Holding financial interests in the evaluated testing facility;- Having a spouse, child, father or mother, sibling, father-in-law, or mother-in-law working for the evaluated testing facility.

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

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