Procedure for Assessing Compliance and Classification of GLP Compliance

According to the provisions of Article 7 of Circular 04/2018/TT-BYT, the regulations are as follows:

* Evaluation procedure:

Step 1: The Evaluation Team announces the Decision on the establishment of the Evaluation Team, the Purpose, content, and tentative evaluation plan at the testing facility.

Step 2: The testing facility presents a summary of the organization, personnel, and activities of implementation and application of GLP or other specific content of the evaluation.

Step 3: The Evaluation Team evaluates the actual implementation of GLP application at the testing facility according to each specific content.

During the evaluation process, the testing facility must carry out actual testing activities.

Step 4: The Evaluation Team meets with the testing facility to inform about the deficiencies discovered during the evaluation (if any); assesses the level of each deficiency; discusses with the testing facility in case the testing facility does not agree with the Evaluation Team's assessment of each deficiency; assesses the compliance level with GLP principles and standards of the testing facility.

Step 5: Prepare and sign the evaluation report:

The evaluation report is signed by the Leader of the testing facility and the Head of the Evaluation Team; the evaluation report must reflect the composition of the Evaluation Team, location, time, evaluation scope, and unresolved issues between the Evaluation Team and the testing facility relating to GLP compliance assessment (if any). The report is made in 03 copies: 01 copy retained at the testing facility, 02 copies retained at the Drug Administration Department.

Step 6: Complete the Evaluation Report

The Evaluation Team is responsible for preparing a GLP Evaluation Report, listing and analyzing, classifying the severity of deficiencies that the testing facility needs to correct, referencing the corresponding regulatory provisions, evaluating the GLP compliance level of the testing facility. Classification of deficiencies and assessment of GLP compliance level of the testing facility are according to the provisions specified in Appendix IV attached to Circular 04/2018/TT-BYT.

Send the GLP Evaluation Report to the testing facility as stipulated at point b, Clause 6, Article 33 of Decree 54/2017/ND-CP.

* Evaluation of GLP compliance level:

The evaluation of GLP compliance level of the testing facility includes the following levels:

- The testing facility complies with GLP at level 1;- The testing facility complies with GLP at level 2;- The testing facility complies with GLP at level 3.

For more information, see: Circular 04/2018/TT-BYT, effective on March 26, 2018.

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