Provisional Regulations on the Use of Drug Testing Vehicles
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Chapter 1 General Provisions Article 1 To strengthen the management of the use of drug testing vehicles (hereinafter referred to as test vehicles), to ensure the efficiency and accuracy of testing vehicles, to improve the pertinence and effectiveness of drug supervision and inspection, and to effectively ensure the safety and effectiveness of drug use for the people. According to the "Drug Administration Law" and Other relevant laws and regulations, these regulations are formulated. Article 2 The State Food and Drug Administration shall be responsible for the supervision and guidance of the use and management of inspection vehicles throughout the country; the China National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for the development and research and training of the national test vehicle technical equipment and systems, as well as the collection of inspection vehicle inspection data across the country. Statistical Analysis. The provincial drug supervision and administration department is responsible for the management, use, and supervision of the inspection vehicles within its jurisdiction; the provincial drug inspection agency is responsible for the technical support, data reporting, and training of the testing personnel in the area under its jurisdiction, as well as the verification of pharmaceutical and biological products in China. Under the guidance of the Institute, the supply of reagents, standards, and laboratory supplies required for testing vehicles is guaranteed. Article 3 The front and the outside of the outer body of the drug testing vehicle shall be marked with “China Drug Supervision†and “Drug Inspection Vehicle†respectively. The font and color shall be uniformly stipulated by the State Food and Drug Administration, and each province shall not change it. The in-vehicle equipment in the test vehicle shall be uniformly equipped and installed by the State, and each use unit shall not disassemble the on-board equipment without authorization.
Chapter II Organizations and Personnel Article 4 Drug regulatory authorities at all levels shall establish a leading group for the inspection vehicle use and management work that is under the leadership of the main leaders, and clearly define the division of labor and responsibilities. The leading group and the division of labor and duties of the inspection and use vehicles of provincial drug regulatory agencies shall be reported to the State Food and Drug Administration for the record. The drug inspection department is responsible for the daily use and management of the vehicle. Article 5 Drug inspection agencies at all levels shall have special departments responsible for the inspection of daily technical support and personnel training for vehicles. Article 6 The inspection vehicles shall be equipped with personnel with high ideological qualities, strong policies, mastery of essential medicine knowledge, and familiarity with the dynamics of drug quality within the jurisdiction. Each inspection vehicle shall be equipped with corresponding drug supervisors and drug testing technicians, and shall remain relatively stable; and it shall have received inspection and training training organized by the drug supervision and administration department at or above the provincial level. After passing the training and getting the induction certificate, you can get on the vehicle to carry out the operation of the drug testing equipment. Those who have not obtained the job certificate must not operate the on-board equipment at will. The drug supervision and testing personnel equipped with the test vehicles shall be filed with the provincial drug regulatory agency. Article 7 Each inspection vehicle shall be equipped with full-time driving personnel, and shall strictly abide by traffic regulations and vehicle management regulations, be familiar with vehicle performance and common sense of maintenance and maintenance, and ensure the normal use of the on-board equipment.
Chapter III Vehicle Management Article 8 A drug testing vehicle must be dedicated to a car and must not be used for other purposes. Article 9 The drug supervision and administration department is responsible for the inspection and maintenance of the vehicles, ensuring that the technical standards of the vehicles are intact and the safety of the on-board equipment, so that the vehicles maintain a good performance state. Drug inspection agencies are responsible for testing the maintenance of vehicle-mounted equipment and ensuring the normal operation of testing equipment. Inside and outside the vehicle must be kept clean and free from dust. Article 10 Each time the test vehicle is used, it must fill out the records of car, car, fuel, and maintenance as required. Before using the vehicle, check whether the odometer of the vehicle matches the previous car record on the record sheet. After the vehicle is used, record the mileage, time, location, and purpose of use. Article 11 Drug detection vehicles shall be parked in a special garage and have corresponding protective measures. Vehicles should pay attention to electricity safety when conducting drug testing, and must also be equipped with fire-fighting equipment that can meet the safety requirements of drug testing. Article 12 If a traffic accident occurs in a vehicle and causes casualties and damage to vehicles and on-board equipment, the provincial drug regulatory authority must report the accident passing and economic loss to the State Food and Drug Administration within 48 hours after the accident. We must actively deal with the aftermath.
Chapter IV Administration of the Use of Instruments and Equipment Article 13 The vehicle-mounted instruments and equipments of the testing vehicle must be managed by special personnel, and establish and improve the management systems and files of various instruments and equipment. There are various technical regulations and methods for the use, maintenance, overhaul, and maintenance of vehicle instruments and equipment, and an annual maintenance plan for instruments and equipment shall be prepared in accordance with the actual operating conditions of the instruments and equipment and combined with the inspection work to ensure that the instruments and equipment are in normal conditions. Article XIV of the drug testing equipment and vehicle equipment should be based on the relevant provisions of the interval and technical specifications require the necessary verification. After the equipment and equipment are repaired, the necessary tests and test operations shall be carried out. After the equipment is qualified, it can be formally put into use. Article 15 After the completion of each inspection work, the instrument operation software shall be withdrawn, the power supply of the computer and the near-infrared spectrometer shall be turned off, the connection of the power cable, the spectrometer and the computer and the light probe shall be removed, and other instruments and equipment shall be checked for their return. Article 16 The inspection vehicle shall maintain an appropriate detection environment when conducting drug testing. The general temperature shall be controlled at 10 to 28°C and the relative humidity shall be controlled at 35% to 75%. When using an external power supply, there should be an uninterruptible power supply regulator. Article 17 Units that use the inspection vehicles shall establish a system for the storage of vulnerable instruments and equipment, reasonably store spare parts and consumables, and do a good job of storing and maintaining instruments and equipment. Article 18 The inspectors shall have the obligation of keeping confidential the passwords of the testing vehicles and the business secrets of the involved inspection units.
Chapter V Inspection Work Procedures Article 19 The drug supervision and administration department shall strictly perform inspections according to the inspection and test items, methods, procedures, and quality control requirements stipulated in the Drug Rapid Test Work Manual. Establish and implement a test quality management system. Article 20 Each time a vehicle is out of the train, a plan must be worked out and a work plan must be submitted to the director of the local drug administration authority for approval. Article 21 The inspection work shall strictly comply with the relevant requirements of the relevant laws, regulations, rules and manuals of the fast inspection work, and carry out supervision, inspection and inspection according to law. The test results issued should be true and accurate. The test results should be signed by the on-site drug supervisors and testers. Article 22 The drug supervisory personnel shall be completed by more than 2 drug supervision and inspection personnel when conducting supervision and inspection and sampling work, and shall fill out the "Sample Notification for Sampling and Testing of Drugs Quick Inspection" according to the facts (see Annex ). Article 23 The violations and violations discovered on the spot during the supervision and inspection and the counterfeit and inferior drugs that do not need to be tested can be dealt with promptly and recorded in the working log of the inspection vehicle. Article 24 When the supervision and inspection site passes the testing equipment or information inquiry of the testing vehicle and the results are inconsistent, it shall be supervised and sampled in accordance with the relevant provisions of the Regulations for the Administration of Drug Quality Supervision and Sampling Inspection and sent to the drug inspection agencies at or above the municipal level for inspection. . Article 25 After each test is completed, the model stability test samples shall be tested in time, data analysis shall be performed, and the verification records shall be filled out. At the same time, the problems encountered in the test methods and varieties, experimental instruments and vehicle operation verification shall be performed. Analyze the summary.
Chapter VI Inspection Data Management Article 26 The China National Institute for the Control of Pharmaceutical and Biological Products is responsible for the version upgrade and data update of the onboard inspection system for drug quick inspection vehicles. The collection, modification, updating, maintenance and use of data resources implement hierarchical authorization management. The authorized personnel shall handle or use the data in accordance with the relevant regulations within the scope of their authority, and ensure that the data is accurate, complete, and secure. Article 27 Each test vehicle shall regularly report the drug test data and supervision and inspection status to the local provincial drug inspection agency through the on-board system. Article 28 Drug inspection agencies shall strengthen the management of rapid drug testing data and establish scientific and reliable test data files. In accordance with relevant regulations, on January 5, April 5, July 5, and October 9 (the holidays are postponed), the provincial-level drug inspection agencies will collect relevant data and report them to the China National Institute for the Control of Pharmaceutical and Biological Products. Article 29 Without the permission of the State Food and Drug Administration, no unit or individual may disclose the relevant data of the test vehicle to the public media; it shall not exceed the scope of authority to handle or use the testing vehicle test data resources; nor in any way. Unauthorized supply or display of test data resources to non-authorized personnel.
Chapter VII Award and Punishment System Article 30 Provincial drug regulatory agencies shall establish reward and punishment systems for the use of testing vehicles and the effectiveness of detection, and actively encourage drug supervision and inspection personnel to study new methods and projects for rapid drug testing. Carry out rewards to grass-roots units and individuals who have made outstanding achievements in the use of inspection vehicles. Article 31 The drug regulatory department at a higher level shall conduct spot checks or flight inspections at any time in the use of test vehicles at various places, and shall order rectification within a time limit for problems found during the inspection. Those who fail to correct their deadlines will be given criticism. Unauthorized changes to the appearance of drug vehicles, dismantling of on-board equipment, changes in the use of vehicles, or failure to use vehicles in accordance with regulations require the provincial and municipal drug regulatory authorities to be held accountable. Article 32 If a vehicle accident or equipment failure is detected due to human factors, the responsible person shall bear the corresponding maintenance cost, and according to the situation, the person in charge of the administrative unit and the person directly responsible shall be subject to criticism, education or administrative sanctions. Article 33 Where a drug supervision and inspection personnel violates regulations, falsifies fraud, engages in malpractice for personal gains, and issues forged results, they shall be dealt with in accordance with the relevant provisions on the investigation of administrative liability faults. Article 34 If the responsible department or staff neglects their duties and abuses their powers, resulting in the loss or leakage of the confidentiality technology or basic data of the test vehicle, or causing adverse consequences or social impact, they shall be given administrative sanctions in accordance with the law; the circumstances are serious and cause direct economic losses. Those who commit crimes of dereliction of duty shall be handed over to the judicial department for criminal responsibility according to law.
Chapter VIII Supplementary Provisions Article 35 The drug test of a test vehicle refers to the analysis, identification and screening of drugs at the site of supervision and inspection by means of rapid detection methods such as instruments, chemical identification, thin-layer chromatography, or physics, so as to judge the quality of drugs initially. Method and means. Article 36 The inspection of drug vehicles must be carried out within the approved test items. The relevant provisions shall be strictly implemented, and no fees shall be charged or disguised. Article 37 The funds required for the operation of the inspection vehicles shall be solved by the provincial drug supervision and administration department. Article 38 This regulation shall be interpreted by the State Food and Drug Administration. Article 39 This provision shall be implemented as of the date of issuance. annex: Provincial Food and Drug Administration Drug fast sampling and testing notice Number: Year Month Day ───────────────────────────────────────── Name of the unit being sampled: Legal representative: address: Telephone: E_mail: Postal Code: ───────────────────────────────────────── Drug Name: Product Name: Marking production units: Drug approval number: Batch number: Number of samples taken: Whether the packaging meets the requirements: Yes â–¡ No â–¡ Sample location: Whether the storage conditions meet the requirements: Yes â–¡ No â–¡ The person in charge of the sampled unit (signature): Supervision and inspection personnel (signature): ───────────────────────────────────────── Detection situation: The above samples were tested according to the 1st edition of the “Snapshot Work Manualâ€. The results were detected in the specified items; 2NIR spectroscopy tests; 3 information system queries. â–¡ 1, in line with; â–¡2. Non-conformity. Inspection by the drug inspection agency is required. Inspector (Signature): Drug Supervisor (Signature): Detection time: Year, month, day and hour detection vehicle number: ───────────────────────────────────────── Sampling unit views: The above test results are no doubt. Need to explain matters: The person in charge of the sampled unit (signed) ───────────────────────────────────────── Note: This notice is made in three simple forms. One copy is retained by the drug regulatory agency, one is retained by the drug inspection agency, and one is retained by the sampled unit. [1]