Chapter I General Provisions Article 1 In order to strengthen the quality management of pharmaceutical business and ensure the safety and effectiveness of people's drug use, this specification is formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and other relevant laws and regulations. Article 2 A pharmaceutical trading enterprise shall carry out quality management on the procurement, storage, transportation and sale of drugs, establish a quality system including organizational structure, responsibility system, process management and facilities and equipment, and make it operate effectively. Article 3 This Code is the basic guideline for the quality management of pharmaceutical trading, and it is applicable to enterprises that exclusively or concurrently engage in pharmaceutical trading in People's Republic of China (PRC) and China. Chapter II Quality Management of Drug Wholesale Section 1 Management Responsibilities Article 4 The principal responsible person of an enterprise shall ensure that the enterprise implements the relevant state laws, regulations and this Code, and assume leadership responsibility for the quality of drugs handled by the enterprise. Article 5 An enterprise shall establish a quality leading organization headed by the principal responsible person of the enterprise. Its main duties are: to establish enterprise quality relations, implement enterprise quality policy, and ensure enterprise quality management personnel to exercise their functions and powers. Article 6 An enterprise shall set up a special quality management organization to exercise its quality management functions and have the right to make decisions on the quality of drugs within the enterprise. Article 7 An enterprise shall set up a drug inspection department, inspection and maintenance institutions and other institutions suitable for its business scale. Drug inspection departments and inspection institutions shall be subordinate to quality management institutions. Article 8 An enterprise shall, in accordance with relevant laws and regulations and this Code, formulate a quality management system in combination with the actual situation of the enterprise, and regularly inspect and evaluate the implementation of the system. Article 9 Enterprises shall conduct internal audits on the implementation of these Standards on a regular basis to ensure the implementation of these Standards. Section 2 Personnel and Training Article 10 The principal person in charge of an enterprise shall have a professional title and be familiar with the laws, regulations and rules of the state on drug administration and the knowledge of drugs handled. Article 11 Among the persons in charge of an enterprise, there should be personnel with professional and technical titles in pharmacy who are responsible for quality management. Article 12 The person in charge of an enterprise's quality management institution shall be a licensed pharmacist or have the corresponding professional title of pharmacy, be able to adhere to principles, have practical experience, and be able to independently solve quality problems in the business process. Article 13 The person in charge of the pharmaceutical laboratory shall have the corresponding professional and technical title of pharmacy. Article 14 The personnel engaged in quality management and inspection of an enterprise shall have a degree in pharmacy or related majors, or have a professional title in pharmacy, and hold relevant certificates after professional training and examination. Fifteenth personnel engaged in acceptance, maintenance, measurement, storage and other work. , should have the corresponding academic qualifications or a certain degree of education, and hold relevant certificates after relevant training and assessment.
Personnel who work in posts with national employment access regulations must pass professional skill appraisal and obtain professional qualification certificates before taking up their posts. Article 16 An enterprise shall organize the personnel who have direct contact with drugs to have health check-ups every year and establish health records. Patients who are found to be suffering from mental illness, infectious diseases or other diseases that may pollute drugs shall be transferred from their posts where they are in direct contact with drugs. Article 17 An enterprise shall regularly educate or train all kinds of personnel on pharmaceutical laws, regulations, rules, professional technology, pharmaceutical knowledge, professional ethics, etc. , and create a file. Section 3 Facilities and Equipment Article 18 An enterprise shall have business premises, auxiliary rooms and office rooms suitable for its business scale. The business premises shall be bright and tidy. Article 19 There shall be warehouses suitable for the scale of operation. The ground in the reservoir area is flat, without water, weeds and pollution sources;
(1) The drug storage work area, the auxiliary work area and the office living area are separated by a certain distance or have isolation measures, and the loading and unloading work area has a roof.
(2) Having warehouses suitable for classified drug storage and meeting the requirements for drug storage. The walls, ceilings and floors in the warehouse are smooth and flat, and the doors and windows are tightly structured.
(three) the reservoir area has fire control and safety facilities that meet the prescribed requirements. Article 20 warehouses shall be divided into special places such as warehouses (districts) to be inspected, qualified warehouses (districts), delivery warehouses (districts), unqualified warehouses (districts), and return warehouses (districts), and special warehouses (districts) for processing Chinese herbal pieces shall also be divided. The above libraries (districts) should be clearly marked. Article 21 A warehouse shall have the following facilities and equipment:
(1) Equipment for keeping medicines at a certain distance from the ground.
(2) Light-proof, ventilation and drainage equipment.
(3) Equipment for detecting and adjusting temperature and humidity.
(four) dust-proof, moisture-proof, mildew-proof, pollution-proof, insect-proof, rat-proof, bird-proof and other equipment.
(five) lighting equipment that meets the requirements of safe electricity use.
(six) there are workplaces suitable for unpacking and LCL, as well as delivery and storage places and equipment for packaging materials. Article 22 Special warehouses for storing narcotic drugs, psychotropic drugs of Category I, toxic drugs for medical use and radioactive drugs shall have corresponding safety measures. Article 23 A drug inspection department shall be set up in accordance with its business scale and scope, and equipped with corresponding inspection instruments and equipment. Chinese herbal medicines and Chinese herbal pieces should be set in the Chinese herbal medicine specimen room (cabinet). Article 24 There shall be an inspection and maintenance room suitable for the scale of the enterprise and meeting the hygiene requirements, equipped with necessary inspection and maintenance tools, instruments and equipment. Twenty-fifth all facilities and equipment should be regularly inspected, repaired and maintained, and files should be established.