6 Steps to Evaluate Good Manufacturing Practices for Drug Storage Compliance

05:36, 11/07/2024

The Ministry of Health recently issued Circular 36/2018/TT-BYT stipulating Good Practice in the Storage of Drugs and Drug Ingredients.

According to the provisions of Circular 36, the assessment of compliance with Good Storage Practices (GSP) for drugs and drug materials is carried out following the procedure below:

- Step 1. The assessment team announces the Decision on the establishment of the Assessment Team, the purpose, content, and assessment plan at the storage facility;- Step 2. The storage facility presents a summary of its organization, personnel, and implementation activities, applying GSP or specific content according to the contents of the assessment;- Step 3. The assessment team conducts an on-site assessment of the implementation and application of GSP at the storage facility for each specific content;- Step 4. The assessment team meets with the storage facility to report on the findings during the assessment process; assesses the severity of each finding; and discusses with the storage facility in case there is disagreement with the assessment team's evaluation;- Step 5. Prepare and sign the assessment minutes;- Step 6. Complete the Assessment Report.

For details of the process, see Circular 36/2018/TT-BYT, effective from January 10, 2019.

- Thanh Lam -

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