PROCEDURES FOR INSPECTION AND CLASSIFICATION OF GMP COMPLIANCE
The Ministry of Health issues the Circular No. 35/2018/TT-BYT good manufacturing practices for pharmaceutical products and pharmaceutical starting materials on November 22, 2018.
Accordingly, procedures for inspection and classification of GMP compliance includes:
- Step 1. The inspectorate shall publish the decision on inspectorate establishment, purposes, contents and plan for the inspection at the manufacturer;
- Step 2. The manufacturer shall make a brief introduction of its organizational structure, personnel and implementation or application of GMP, or specific contents in conformity with the inspected contents;
- Step 3. The inspectorate shall carry out a site inspection of the application of GMP at the manufacturer. If the manufacturer enters one or some stages of the manufacturing process, only GMP applied to such stages is inspected;
- Step 4. The inspectorate shall have a talk with the manufacturer about deficiencies found during the inspection (if any) and assess the level of each deficiency; discuss with the manufacturer in case the manufacturer does not agree with the inspectorate about the assessment of each deficiency or level of GMP compliance;
- Step 5. An inspection record is prepared and signed;
- Step 6. The inspection record is completed.
This Circular takes effect on January 10, 2019.
