Vietnam: Process of inspecting and measuring fulfillment of GPP requirements

Specifically, according to Article 7 of the Circular No. 02/2018/TT-BYT of the Ministry of Health of Vietnam:

* Inspection process:

Step 1: The inspection team will declare the Decision on establishment of inspection team, objectives, contents and plan for the site inspection at the pharmacy premises;

Step 2: The applicant shall briefly state contents about its organizational structure, personnel and implementation or application of GPP standards, or specific contents in conformity with the inspected contents;

Step 3: The inspection team shall inspect and evaluate the application of GPP standards at the pharmacy premises;

Step 4: The inspection team shall have a talk with the applicant about any deficiencies found in the site inspection and the degree of each deficiency; discuss with the applicant in case the applicant does not agree with the inspection team about any deficiency; evaluate and determine the degree of fulfillment of GPP requirements by the applicant;

Step 5: Preparing and certifying inspection report:

The inspection team shall prepare the report on inspection of fulfillment of GPP requirements using the Form No. 02 stated in the Appendix III enclosed herewith. The inspection report must clearly specify the degree of fulfillment of GPP requirements by the pharmacy as prescribed in Clause 2 and Clause 3 of this Article, and deficiencies requiring corrective actions (if any); disagreements between the inspection team and the applicant after careful consideration of the complete checklist pursuant to relevant provisions for such type of pharmacy.

The inspection report must be certified by signatures of the pharmacy manager and the inspection team leader. The inspection report must include contents describing the composition of the inspection team, location, time and extent of inspection, and is prepared in three copies, two of which shall be kept by the Provincial Department of Health and the other is kept by the applicant.

* Scoring rule:

- The standard point for each criterion is prescribed in the Checklist stated in the Appendix II 2a, 2b, 2c enclosed herewith according to the step-by-step scoring rule. Each criterion will be given the maximum points; no intermediate points will be given. Plus points will be given if the pharmacy fully complies with GPP requirements. Minus points will be given if the pharmacy partially complies with GPP requirements;

- An operating pharmacy will be evaluated and scored according to its operations actually carried out;

- With regard to a newly established pharmacy:

+ Criteria applied before its operation will be scored according to actual results;

+ Criteria applied after the pharmacy officially starts its operations will be scored by consideration and evaluation of its documents, records, SOP, forms to be used during its operation and evaluation of its personnel (whether they have a thorough understanding of and comply with regulations relating their duties.

Total points used to determine the degree of fulfillment of GPP requirements by a newly established pharmacy shall exclude points of criteria for activities which are not performed by the pharmacy (for example, the pharmacy does not concoct drugs according to prescriptions or the pharmacy does not have a drug storage).

* Determination of degrees of fulfillment of GPP requirements:

- The pharmacy is considered to have complied with GPP requirements if it has no criterion given the “non-compliance” points and achieves at least 90% of total points;

- The pharmacy is required to submit report on corrective actions taken if it has no criterion given the “non-compliance” points and achieves from 80% to under 90% of total points;

- The pharmacy fails to comply with GPP requirements if it has any criteria given the "non-compliance" points or achieves less than 80% of total points.

View more details at the Circular No. 02/2018/TT-BYT of the Ministry of Health of Vietnam, effective from March 08, 2018.

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