The key points for drug marketing authorization holder inspection are mainly used to provide guidance to drug regulatory authorities at all levels when conducting supervision and inspection on drug marketing authorization holders (hereinafter referred to as holders). Drug regulatory authorities at all levels should conduct inspections on the entire system or part of the system of the holder based on risks and focusing on the products in accordance with the key points for inspection.
For holders who develop, produce, and operate drugs by themselves and the trustees who are entrusted by the holders to develop, produce, and operate drugs, in addition to inspections in accordance with the requirements of these key points for inspection, they should also conduct inspections on the implementation of regulatory documents such as the "Regulations on Drug Registration Management", "Regulations on Drug Production Supervision and Management", "Good Manufacturing Practice for Drugs", "Good Operation Practice for Drugs", "Good Non-clinical Research Practice for Drugs", and "Good Clinical Trial Practice for Drugs" in accordance with the relevant provisions of drug supervision and inspection.
I. Organization and Personnel
(I) Whether the holder has established an organizational structure suitable for product quality, production, and safety management, and whether the responsibilities of each department are clearly defined.
(II) Whether the holder has sufficient personnel with appropriate qualifications and capabilities; whether the relevant job responsibilities are clear and comply with relevant laws and regulations; whether key personnel are regularly trained on laws and regulations related to drug management; whether key personnel are full-time personnel, including: legal representative, enterprise head, production management person in charge (if any), quality management person in charge, quality authorized person. Check and confirm the labor contract/appointment letter/authorization letter, job description, academic qualifications and major, professional work experience, professional knowledge training and assessment, performance of duties and penalties received by drug supervision and management departments of drug quality and pharmacovigilance management personnel.
(III) Whether regulations on employee health examinations have been established and implemented for staff who directly contact drugs, including whether appropriate measures have been taken to avoid the possibility of drug contamination for those with infectious diseases or other diseases that may contaminate drugs.
II. Quality Assurance System
(I) Whether the holder has established a drug quality assurance system and is responsible for the quality of its marketed drugs. For the holders who entrust other enterprises to carry out drug research and development, production, operation, and drug vigilance related activities, whether their quality assurance system can be effectively connected with the quality assurance system of the entrusted enterprise, fulfill the responsibility of drug release, be responsible for the quality of the drugs for which they have obtained drug registration certificates, and ensure that the drugs are safe, effective and quality-controlled during their life cycle.
(II) Whether an annual reporting system in accordance with the provisions of laws and regulations has been established and implemented in accordance with the system.
(III) Whether a drug traceability system and system in accordance with the provisions of laws and regulations has been established, and complete and accurate data is provided to the drug traceability collaborative service platform in accordance with regulations; when selling drugs, it should ensure that downstream enterprises or medical institutions can conduct effective traceability.
(IV) Whether rules and regulations to ensure drug quality have been established and meet the requirements of the "Good Manufacturing Practice for Pharmaceuticals" and/or "Good Distribution Practice for Pharmaceuticals". Whether the holder who entrusts other enterprises to carry out drug development, production, and operation-related activities (including drug storage and transportation) has established and implemented the following rules and regulations; whether the relevant activities have completed relevant records or reports in accordance with regulations; whether the relevant system and the quality assurance system documents of the entrusted enterprise can be effectively connected, including but not limited to:
1. Drug quality review and analysis system and drug quality review and analysis report;
2. The holder's audit procedures, on-site audit reports and records of the entrusted enterprise;
3. Drug marketing release management procedures and records;
4. Development, production, and operation supervision and management procedures and records;
5. Drug quality complaint management procedures, records and reports;
6. Drug return management procedures and records;
7. Drug recall management procedures and records ;
8. Deviation management procedures and records;
9. Change control procedures and records;
10. Drug quality standards and testing procedures documents;
11. Production process regulations and blank batch production records;
12. List of qualified suppliers of materials directly related to drug quality;
13. Regulations and communication records for quality information communication and disposal;
14. List of co-production products of entrusted production enterprises and risk assessment report (or relevant procedures and records/reports on avoiding contamination and cross-contamination);
15. Self-inspection management procedures and records;
16. Procedures and records for handling non-conforming products;
17. Management procedures and records for corrective and preventive measures;
18. Special drug management procedures and blank records (for special drug users).
(V) For entrusting other enterprises to carry out drug research, production, and operation-related activities (including storage and transportation of drugs), whether they have been filed in accordance with regulations, whether they have been reviewed and evaluated regularly in accordance with regulations, whether they have signed a commissioning agreement and/or quality agreement that meets the requirements, whether they have been approved or filed in accordance with regulations, and whether they have been implemented in accordance with the agreement. Whether the qualifications of the entrusted party comply with the provisions of laws and regulations.
(VI) Whether there are any illegal or irregular acts of entrusted production or re-entrusting others to produce (sub-entrustment).
(VII) Whether a management system that complies with the requirements of laws and regulations has been established for deviations and changes in the drug production process, which can comprehensively evaluate and verify the impact of changes on drug safety, effectiveness and quality controllability, and implement classified management in accordance with regulations.
Whether the relevant system establishes management procedures for changes in the organizational structure, principal person in charge, production person in charge, quality person in charge, and quality authorized person related to the quality management system, and whether changes are applied or registered in accordance with the requirements of laws and regulations.
(VIII) Whether the holder fulfills the change management responsibilities in accordance with the technical requirements of the change, completes the registration of its production site in the drug variety file; whether the drug variety file is ensured to be true, accurate and timely updated.
III. Pharmacovigilance Management
(I) Whether the holder has established a pharmacovigilance system in accordance with regulations, effectively monitors, collects, investigates, analyzes and judges adverse drug reactions and other adverse reaction signals related to drug use, promptly handles quality and safety risks, and performs relevant duties.
(II) Whether the holder has established the following rules and regulations and strictly implemented them, and whether the relevant activities have completed the corresponding records or reports in accordance with the regulations. If other companies are entrusted to carry out drug vigilance, whether the relevant systems can be effectively connected with the corresponding system documents of the entrusted company, including but not limited to:
1. Drug adverse reaction monitoring procedures and reports;
2. Establish and preserve the system and files for drug adverse reaction monitoring files;
3. Carry out the system and records of reporting, investigation, evaluation and handling of drug adverse reactions or group adverse events;
4. Submit the system and report of regular safety update reports;
5. Carry out the system and records of key monitoring.
6. If other companies are entrusted to carry out drug vigilance related activities, whether a drug vigilance entrustment agreement that meets the requirements has been signed.
(III) The holder's public contact information and operation status (including website, public office address, and validity of contact information).
IV. Risk Management
(I) Whether a risk management system has been established, and a system that meets the requirements of laws and regulations has been formulated, and the corresponding records or reports have been completed in accordance with regulations. Including but not limited to:
1. Post-marketing drug risk management procedures and plans;
2. Shortage drug suspension reporting system and records/reports;
3. Drug safety incident handling plan, training and emergency drill records;
(II) Whether a drug production risk management procedure has been established (whether the holder who entrusts other companies to produce has established a corresponding connection procedure), and whether risk assessment, control, communication, review, review and other quality management activities have been carried out, the cycle and circumstances of risk assessment have been determined, and effective risk control measures have been taken in a timely manner for identified risks to ensure product quality.
(III) Whether corresponding risk assessment tools and methods are selected for different risk items or data.
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