Dossier on the Basis for Evaluating Compliance with Good Laboratory Practices

23:49, 11/07/2024

Good Laboratory Practices (GLP) are a set of principles and standards for quality management systems related to the organization and conditions for conducting non-clinical studies in pharmaceutical activities for human health and environmental safety that are planned, performed, monitored, recorded, archived, and reported.

According to the regulations in Circular 04/2018/TT-BYT, the dossier serving as the basis for evaluating GLP compliance for pharmaceutical business establishments is the application for the Grant of Certificate of Eligibility for Pharmaceutical Business (submitted when applying for the Grant of Certificate of Eligibility for Pharmaceutical Business, the testing facility does not need to submit this dossier again) as prescribed in Article 38 of the Pharmaceutical Law and Article 32 of Decree 54/2017/ND-CP.

In cases where the drug testing facility must follow special control regulations, it shall comply with Article 38 of the Pharmaceutical Law and Article 49 of Decree 54/2017/ND-CP.

For technical documents regarding the testing facility, they are to be presented following the dossier guidelines stipulated in Appendix III attached to Circular 04/2018/TT-BYT or the updated overall dossier in case of expanding the scope of activities.

The dossier serving as the basis for evaluating GLP compliance for non-commercial testing facilities includes:

- Application form for GLP compliance evaluation;- Technical documents regarding the testing facility presented in accordance with the overall dossier guidelines stipulated in Appendix III attached to Circular 04/2018/TT-BYT.

In case the testing facility applies for the GLP Certificate together with the Certificate of Eligibility for Pharmaceutical Business, the testing facility must clearly state this content in the Application for the Grant of Certificate of Eligibility for Pharmaceutical Business.

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

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