Flight Inspection Methods for Drugs and Medical Devices

Chapter I General Principles Article 1 In order to strengthen the supervision and inspection of drugs and medical devices, strengthen the safety risk prevention and control, according to the "Chinese People's *** and the State Drug Administration Law", "Chinese People's *** and the State Drug Administration Law Enforcement Regulations", "Regulations for the Supervision and Administration of Medical Devices" and other relevant laws and regulations, to formulate these measures. Article 2 The flight inspection of drugs and medical devices referred to in these measures refers to the supervision and inspection without prior notice carried out by the food and drug supervision and management department for the development, production, operation and use of drugs and medical devices. Article 3 The State Food and Drug Administration is responsible for the organization and implementation of nationwide flight inspection of drugs and medical devices. Local food and drug supervision and management departments at all levels are responsible for the organization and implementation of the administrative region of the flight inspection of drugs and medical devices. Article 4 The flight inspection of medicines and medical devices shall follow the principles of independence, objectivity and impartiality, scientific treatment in accordance with the law, and be carried out around the prevention and control of safety risks. Article 5 The inspected unit of the food and drug supervision and management department shall cooperate with the organization and implementation of the flight inspection of pharmaceutical and medical equipment, shall not refuse, evade or obstruct. Article 6 The food and drug supervision and management departments should be in accordance with the requirements of government information disclosure of the results of the inspection, the major or typical cases, you can take the press release and other means of public disclosure to the community. Article 7 The food and drug supervision and management departments and relevant staff shall strictly abide by the relevant laws and regulations, integrity discipline and work requirements, shall not be inspected to put forward requirements unrelated to the inspection of the unit, and shall not disclose the flight inspection-related information, informant information and commercial secrets of the unit to be inspected. Chapter II initiation of Article 8 of the following circumstances, the food and drug supervision and management department can carry out flight inspection of drugs and medical devices:

(a) complaints or other sources of clues indicating that there may be a risk of quality and safety;

(b) test found that there is a risk of quality and safety;

(c) adverse reactions to medicines or medical devices adverse event monitoring suggests that there may be a risk of quality and safety. Monitoring suggests that there may be quality and safety risks;

(D) the authenticity of the declaration of information in doubt;

(E) suspected of serious violations of quality management standards;

(F) serious non-compliance with the record of the enterprise;

(VII) other need to carry out flight inspection circumstances. Article IX to carry out flight inspection should be formulated to check the program, clear inspection matters, time, composition and mode of personnel and so on. Need to use the identity of the way to investigate the non-public, the inspection program should be clear.

When necessary, the food and drug supervision and management departments can jointly with the public security organs and other relevant departments **** with the flight inspection. Article X food and drug supervision and management departments to send an inspection team should be composed of more than two inspectors, the inspection team to implement the system of responsibility of the team leader. Inspectors should be food and drug law enforcement officers, inspectors qualified according to law or other personnel authorized to obtain the inspection; according to the needs of the inspection work, food and drug supervision and management departments can ask experts in related fields to participate in the inspection work.

Personnel participating in the inspection should sign a declaration of no conflict of interest and integrity commitment; engaged in inspection activities and their personal interests may be contradictory or conflict, should take the initiative to avoid. Article 11 The inspection team shall investigate and verify the actual situation of the inspected unit to implement the laws and regulations for the supervision of drugs and medical devices, in accordance with the inspection program to clarify the focus of the on-site inspection, and can be based on the risk of research and evaluation of the risk management and control plan. Article 12 The members of the inspection team shall not inform the inspected unit in advance of the inspection itinerary and inspection content, after the designated place of concentration, the first time directly into the inspection site; directly targeting possible problems to carry out the inspection; shall not disclose the progress of the inspection process, the discovery of clues of violations of the law and other relevant information. Article XIII of the higher food and drug supervision and management departments to organize the implementation of flight inspection, can be timely notification of the unit being inspected by the local food and drug supervision and management departments. The food and drug supervision and management department of the location of the inspected unit should be sent to assist in the inspection, assist in the inspection of the personnel should be subject to the arrangements of the inspection team. Article XIV of the organization of the implementation of flight inspection of food and drug supervision and management departments should strengthen the command of the inspection team, according to the feedback of the on-site inspection of the timely adjustment of coping strategies, if necessary, to start the coordination mechanism, and can be sent to the scene of the relevant personnel to coordinate and command. Chapter III Inspection Article 15 After the inspection team arrives at the inspection site, the inspector shall show the relevant documents and law enforcement documents assigned by the food and drug supervision and management department to carry out supervision and inspection, and inform the inspection requirements and the rights and obligations of the inspected unit. Article XVI of the inspected unit and the relevant personnel should be in a timely manner in accordance with the requirements of the inspection team, a clear inspection of the person in charge of the site, open the relevant places or areas, with the inspection of relevant facilities and equipment, to maintain normal production and operation of the state, to provide a true, valid, complete documents, records, bills, vouchers, electronic data and other related materials, and truthful answers to the inspection team's inquiries. Article 17 The inspection team shall make detailed records of the inspection time, location, site conditions, etc.; the problems found shall be recorded in writing, and according to the actual situation to collect or copy the relevant documents and information, photographing the relevant facilities, equipment and materials and other physical and on-site conditions, collecting physical and questioning of the relevant personnel. Inquiry records should include the name of the subject of the inquiry, the work position and the content of the conversation, and by the subject of the inquiry page by page signature or fingerprints.

Records should be timely, accurate, complete, objective and true reflection of the situation on-site inspection.

Records formed during the flight inspection and the collection of relevant information, objects, etc., can be used as the basis for administrative penalties in the determination of the facts.