What are the quality management systems that enterprises should formulate, and what are the quality management standards for drug handling?

Chapter I General Principles

Article 1 In order to strengthen the quality management of pharmaceutical trading, standardize pharmaceutical trading behaviors, and ensure the safety and effectiveness of human drug use, this Regulation is formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and the Implementation Regulations of the Drug Administration Law of People's Republic of China (PRC).

Article 2 This Code is the basic guideline for drug management and quality control. Enterprises should take effective quality control measures in the procurement, storage, sales and transportation of drugs to ensure the quality of drugs.

Article 3 Pharmaceutical trading enterprises shall strictly implement this Code.

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 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 in accordance with relevant laws and regulations and the requirements of this Code.

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 Organization and Quality Management Responsibilities

Article 13 An enterprise shall set up an organization 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 III Personnel and Training

Article 18 Personnel engaged in pharmaceutical trading and quality management in enterprises shall meet the qualifications stipulated in relevant laws and regulations and this Code, and have not been prohibited from practicing by relevant laws and regulations.

Article 19 The person-in-charge of an enterprise shall have a college degree or above or an intermediate title, have been trained in basic knowledge of pharmacy, and be familiar with relevant laws and regulations on drug administration and this specification.

Article 20 The person in charge of enterprise quality shall have a bachelor's degree or above, the qualification of licensed pharmacist and more than 3 years' experience in quality management of pharmaceutical business, and have the ability to correctly judge and ensure implementation in quality management.

Article 21 The person in charge of the quality management department of an enterprise shall have the qualification of licensed pharmacist and more than 3 years' working experience in quality management of pharmaceutical business, and be able to independently solve the quality problems in the business process.

Twenty-second enterprises should be equipped with quality management, acceptance and maintenance personnel who meet the following qualifications:

(a) engaged in quality management, should have a technical secondary school degree or above in pharmacy or medicine, biology, chemistry and other related majors, or have a primary professional and technical title in pharmacy;

(2) Personnel engaged in acceptance and maintenance work shall have technical secondary school education or above in pharmacy or medicine, biology, chemistry and other related majors, or have professional technical titles above junior level in pharmacy;

(3) Those who are engaged in the acceptance of Chinese herbal medicines and Chinese herbal pieces shall have a technical secondary school degree or above in Chinese medicine or a professional technical title above the intermediate level in Chinese medicine; Engaged in the maintenance of Chinese herbal medicines and Chinese herbal pieces, should have a technical secondary school degree or above in Chinese medicine or a primary title in Chinese medicine; Direct acquisition of real estate Chinese herbal medicines, acceptance personnel should have intermediate or above Chinese medicine professional and technical titles.

Enterprises engaged in vaccine business should also be equipped with more than two professional and technical personnel responsible for vaccine quality management and acceptance. Professional and technical personnel should have a bachelor's degree or above in preventive medicine, pharmacy, microbiology or medicine, and have more than three years of experience in vaccine management or technical work.

Twenty-third personnel engaged in quality management and acceptance should be on-the-job, and may not work part-time in other business positions.

Article 24 Personnel engaged in purchasing should have a secondary school education or above in pharmacy or medicine, biology, chemistry and other related majors, and personnel engaged in sales and warehousing should have a high school education or above.

Twenty-fifth enterprises should carry out pre-job training and continuing training related to their duties and work contents in order to meet the requirements of this specification.

Twenty-sixth training content should include relevant laws and regulations, pharmaceutical professional knowledge and skills, quality management system, job responsibilities and operating procedures.

Article 27 An enterprise shall formulate an annual training plan and carry out training according to the training management system, so that relevant personnel can correctly understand and perform their duties. Training work should be recorded and files should be established.

Twenty-eighth personnel engaged in the storage and transportation of specially managed drugs and frozen drugs shall receive relevant laws and regulations and professional knowledge training, and can only take up their posts after passing the examination.

Article 29 An enterprise shall formulate a personal hygiene management system for its employees, and the clothing of personnel in warehousing, transportation and other positions shall meet the requirements of labor protection and product protection.

Thirtieth direct contact with drug quality management, acceptance, maintenance, storage and other personnel should be pre-job and annual health examination, and establish health records. Persons suffering from infectious diseases or other diseases that may contaminate drugs shall not engage in direct contact with drugs. If the physical condition does not meet the specific requirements of the corresponding post, he shall not engage in related work.

The fourth quarter quality management system documents

Article 31 The quality management system documents formulated by an enterprise shall conform to the actual situation of the enterprise. Documents include quality management system, department and post responsibilities, operating procedures, documents, reports, records and vouchers, etc.

Article 32 The drafting, revision, review, approval, distribution, storage, modification, revocation, replacement and destruction of documents shall be carried out in accordance with the Operating Rules for Document Management, and relevant records shall be kept.

Article 33 A document shall indicate its title, type, purpose, document number and version number. Use words accurately, clearly and easily.

Documents should be classified and stored for easy reference.

Article 34 An enterprise shall regularly review and revise the documents, and the documents used shall be the current valid texts. The abolished or invalid documents shall not appear on the job site except for filing for future reference.

Article 35 An enterprise shall ensure that each post obtains the necessary documents corresponding to its work content and carry out its work in strict accordance with the regulations.

Article 36 The quality management system shall include the following contents:

(1) Provisions on internal audit of quality management system;

(two) the provisions of the quality veto;

(3) Management of quality management documents;

(4) Quality information management;

(5) Provisions on the qualification examination of suppliers, purchasers, sales personnel of suppliers and procurement personnel of purchasers;

(six) the management of drug procurement, receipt, acceptance, storage, maintenance, sales, distribution and transportation;

(7) Provisions on the special administration of drugs;

(eight) the management of the validity period of drugs;

(nine) the management of substandard drugs and drug destruction;

(ten) drug return management;

(eleven) drug recall management;