Procedure for Assessing and Classifying Compliance with GDP Requirements

To be specific, according to Article 7 of Circular No. 03/2018/TT-BYT, the procedure for evaluating compliance and classifying compliance with Good Distribution Practice (GDP) for drugs and drug substances is regulated as follows:

* Evaluation Procedure:

Step 1: The Evaluation Team announces the Decision on the establishment of the Evaluation Team, the purpose, content, and expected evaluation plan at the distribution facility.

Step 2: The distribution facility presents a summary of the organization, personnel, and activities related to the implementation and application of GDP or specific contents according to the evaluation schedule.

Step 3: The Evaluation Team conducts an actual evaluation of the implementation and application of GDP at the distribution facility according to specific contents.

Step 4: The Evaluation Team meets with the distribution facility to inform about any findings discovered during the evaluation (if any); assesses the severity of each finding; discusses with the distribution facility in case the facility does not agree with the Evaluation Team's assessment of each finding; evaluates the compliance level of the distribution facility with GDP principles and standards.

Step 5: Preparing and signing the report:

The Evaluation Team is responsible for preparing the GDP Evaluation Report according to Form No. 03 provided in Appendix IV attached to this Circular. The report must classify the compliance level of the distribution facility with GDP as specified in Clauses 2 and 3 of this Article and list and analyze any deficiencies that need to be addressed and corrected (if any); the contents agreed and disagreed upon between the Evaluation Team and the distribution facility.

The GDP Evaluation Report must be signed by the Head of the Distribution Facility and the Head of the Evaluation Team. The report must show the composition of the Evaluation Team, location, time, scope of evaluation, and be made in 03 copies: 01 copy to be kept at the distribution facility and 02 copies to be kept at the Department of Health.

* Evaluation of GDP Compliance Levels:

The evaluation of GDP compliance levels of the distribution facility according to the provisions in Appendix IV attached to this Circular includes the following levels:

- Level 1 GDP Compliance of Distribution Facility;- Level 2 GDP Compliance of Distribution Facility;- Level 3 GDP Compliance of Distribution Facility.

See also: Circular No. 03/2018/TT-BYT, effective March 26, 2018.

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