The National Medical Products Administration (NMPA) has released revised provisions of the “Drug Inspection Management Measures” and is soliciting public feedback on the proposed changes before the deadline of July 10, 2023. The initial “Drug Inspection Management Measures (Trial)” were introduced on May 28, 2021, with the aim of standardizing drug inspection behavior and promoting drug supervision to adapt to new circumstances promptly. The current revision primarily specifies detailed inspection items and standards, with comprehensive evaluation standards listed separately.
Key Revisions and Procedures:
- Inspection Team Requirements:
During on-site inspections, if there are fewer than 2 law enforcement personnel involved in enforcement activities such as supervision sampling and evidence collection, the drug supervision and management department overseeing the inspected unit must dispatch at least 2 law enforcement personnel to participate in the inspection work. - Inspection Planning:
Before conducting an inspection, the dispatched inspection unit must develop an inspection plan based on the inspection task, taking into account the inspected unit’s previous inspection history, production site conditions, dosage form characteristics, and production processes. Inspectors involved in the inspection should familiarize themselves with inspection materials and other content in advance. - On-Site Inspection Conclusions:
The on-site inspection conclusion is categorized into compliance, evaluation after rectification, and non-compliance. The comprehensive evaluation conclusion is divided into meeting the requirements and not meeting the requirements. - Comprehensive Evaluation Criteria:
- If no defects are found or the quality and safety risks are minor, and the quality management system is relatively sound, or if defects are found with certain quality and safety risks but the quality management system is basically sound and can operate effectively after enterprise rectification, the evaluation conclusion is that it meets the requirements.
- If defects are found with serious quality and safety risks, and the quality management system cannot operate effectively, or if defects are found with certain quality and safety risks but the quality management system cannot operate effectively after enterprise rectification, the evaluation conclusion is that it does not meet the requirements.
- Review and Audit Process:
The dispatched inspection unit must review the on-site inspection report within 15 working days of receipt and form an audit opinion. If necessary, defective items and inspection conclusions can be readjusted and identified. If the inspection conclusion after review is to be evaluated after rectification, the dispatched inspection unit must form a comprehensive evaluation conclusion within 20 working days of receiving the rectification report, issue a “Drug Inspection Comprehensive Evaluation Report”, and submit it to the drug regulatory department. If the inspection conclusion after the audit is that it meets or does not meet the requirements, the dispatched inspection unit must form a comprehensive evaluation conclusion within 5 working days from the date of conclusion recognition, issue a “Drug Inspection Comprehensive Evaluation Report”, and submit it to the drug regulatory department. The drug regulatory department shall issue a “Notice of GMP/GSP Compliance Inspection” based on the “Comprehensive Evaluation Report on Drug Inspection” and provide it to the inspected unit in a timely manner. - Rectification by Inspected Units:
After the on-site inspection is completed, the inspected unit must rectify the defective items within 20 working days. If the defective project is adjusted and reissued after being reviewed by the dispatched inspection unit, the rectification deadline can be extended by 10 working days. If the rectification cannot be completed on time, a practical and feasible rectification plan should be formulated and included in the rectification report as the completion of the corresponding defect rectification. The inspected unit must actively take necessary risk prevention and control measures based on the defects and risks discovered during the rectification period.-Fineline Info & Tech
