Regulations on Ad hoc Inspection of Good Pharmaceutical Storage Practices

05:37, 11/07/2024

Circular 36/2018/TT-BYT has been issued by the Ministry of Health stipulating Good Practices for Storage of Medicines and Drug Ingredients.

According to Circular 36, in the following cases, the competent authority will conduct a surprise assessment of the maintenance of Good Storage Practices (GSP) for drugs and drug materials at the storage facility:

- The storage facility has not met the requirements stipulated in Point c Clause 4 Article 11 Section 2 of Circular 36;- The storage facility complies with GSP at level 2 or 3 as specified in Points b and c Clause 3 Article 7 of Circular 36 and must undergo at least one surprise assessment within 03 years from the date of the conclusion of the previous assessment;- The storage facility has had inspection results or checks by competent authorities concluding severe violations of GSP principles and standards;- In cases where there is information reflecting or denouncing serious violations of GSP principles and standards by the storage facility;- The storage facility fails to submit activity reports and maintain GSP compliance as stipulated in Clause 5 Article 9 of Circular 36.

More details can be found in Circular 36/2018/TT-BYT, effective from January 10, 2019.

- Thanh Lam -

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