Vietnam: Documents used as basis for inspection of fulfillment of GPP requirements

Documents used as the basis for an inspection of fulfillment of GPP requirements by a pharmacy are those included in its application for Certificate of eligibility for pharmacy business (the pharmacy is not required to submit these documents because they have been submitted when the pharmacy applies for the Certificate of eligibility for pharmacy business) as prescribed in Article 38 of the Law on Pharmacy 2016 of Vietnam and Article 32 of Decree No. 54/2017/NĐ-CP of Vietnam’s Government.

If a pharmacy trades in controlled drugs, it must have the documents prescribed in Article 38 of the Law on Pharmacy 2016 of Vietnam and Article 49 of the Decree No. 54/2017/NĐ-CP.

Technical documents of a pharmacy include:

- The organizational chart, list of employees, names, positions and qualifications of employees;

- The layout plan displaying all areas of a pharmacy;

- The list of equipment (including information concerning computer system and management software);

- The list of regulations, dossiers, documentation system and standard operating procedure (SOP);

- The complete GPP checklist made according to the form stated in the Appendix II 2a or 2b or 2c enclosed with Circular No. 02/2018/TT-BYT.

If a pharmacy applies for both GPP Certificate and Certificate of eligibility for pharmacy business, this content must be clearly specified in its application form for Certificate of eligibility for pharmacy business.

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

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE