Pharmaceutical production enterprises selling drugs and other drugs involved in storage and transportation in the process of drug circulation shall also meet the relevant requirements of this specification. Article 4 Pharmaceutical trading enterprises shall adhere to honesty and trustworthiness and operate according to law. Any false or deceptive behavior is prohibited. Chapter II Quality Management of Drug Wholesale Section 1 Quality Management System Article 5 An enterprise shall, in accordance with the requirements of relevant laws and regulations and this Code, establish a quality management system, determine quality policies, formulate quality management system documents, and carry out activities such as quality planning, quality control, quality assurance, quality improvement and quality risk management. Article 6 The quality policy documents formulated by an enterprise shall specify the overall quality objectives and requirements of the enterprise, and shall run through the whole pharmaceutical trading activities. Article 7 An enterprise's quality management system shall be suitable for its business scope and scale, including organization, personnel, facilities and equipment, quality management system documents and corresponding computer systems. Article 8 An enterprise shall regularly organize internal audits and organize internal audits when the elements of the quality management system have undergone major changes. Article 9 An enterprise shall analyze the internal audit, formulate corresponding measures to improve the quality management system according to the analysis conclusions, continuously improve the quality control level, and ensure the continuous and effective operation of the quality management system. Article 10 An enterprise shall evaluate, control, communicate and review the quality risks in the process of drug circulation in a forward-looking or retrospective way. Article 11 An enterprise shall evaluate the quality management systems of drug suppliers and purchasers, confirm their quality assurance ability and quality reputation, and conduct on-the-spot investigations when necessary. Twelfth enterprises should participate in quality management. All departments and post personnel should correctly understand and perform their duties and assume corresponding quality responsibilities. Section 2 Organizational Structure and Quality Management Responsibilities Article 13 An enterprise shall set up an organizational structure or post suitable for its business activities and quality management, and define its responsibilities, authority and relationship. Article 14 The person in charge of an enterprise is the main person in charge of drug quality, who is fully responsible for the daily management of the enterprise, and is responsible for providing necessary conditions to ensure that the quality management department and quality management personnel can effectively perform their duties, ensure that the enterprise can achieve the quality objectives, and handle drugs according to the requirements of this specification. Article 15 The person in charge of enterprise quality is a senior manager, who is fully responsible for drug quality management, performs his duties independently, and has the power of adjudication on drug quality management within the enterprise. Article 16 An enterprise shall set up a quality management department to effectively implement quality management. The responsibilities of the quality management department shall not be performed by other departments and personnel. Seventeenth quality management departments shall perform the following duties:
(a) to urge the relevant departments and post personnel to implement the laws and regulations on drug administration and this specification;
(two) to organize the formulation of quality management system documents, and to guide and supervise the implementation of the documents;
(3) To be responsible for auditing the legality of suppliers and purchasers, the legality of drugs purchased, and the legal qualifications of sales personnel of suppliers and purchasers, and to conduct dynamic management according to the changes of the auditing contents;
(four) responsible for the collection and management of quality information, the establishment of drug quality files;
(five) responsible for drug acceptance, guidance and supervision of drug procurement, storage, maintenance, sales, return, transportation and other aspects of quality management;
(six) to be responsible for the confirmation of unqualified drugs and supervise the treatment process of unqualified drugs;
(seven) responsible for the investigation, handling and reporting of drug quality complaints and quality accidents;
(eight) responsible for reporting counterfeit and inferior drugs;
(nine) responsible for drug quality inquiry;
(ten) responsible for guiding the setting of computer system quality control function;
(eleven) responsible for the audit of computer system operation authority and the establishment and update of basic data of quality management;
(twelve) to organize the verification and calibration of relevant facilities and equipment;
(thirteen) responsible for drug recall management;
(fourteen) responsible for the report of adverse drug reactions;
(fifteen) to organize the internal audit and risk assessment of the quality management system;
(sixteen) to organize the inspection and evaluation of the quality management system and service quality of drug suppliers and buyers;
(seventeen) to organize the examination of the transportation conditions and quality assurance ability of the entrusted carrier;
(eighteen) to assist in quality management education and training;
(nineteen) other duties that should be performed by the quality management department. Section 3 Personnel and Training Article 18 Personnel engaged in pharmaceutical trading and quality management in an enterprise shall meet the qualification requirements stipulated in relevant laws and regulations and this Code, and have not been prohibited from practicing by relevant laws and regulations.