Pharmaceutical management quality management practices_Jiangxi Biological Products Research Institute Co., Ltd.

Pharmaceutical Management Quality Management Regulations (Order No. 90 of the Ministry of Health)

National Health and Family Planning Commission of the People's Republic of China www.moh.gov.cn

No. 90

The "Good Manufacturing Practices" was reviewed and approved by the Ministry of Health of the Ministry of Health on November 6, 2012. It is hereby promulgated and will be implemented as of June 1, 2013.

Minister Chen Hao

January 22, 2013

Pharmaceutical management quality management practices

Chapter 1 General

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

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

Article 3 Pharmaceutical enterprises shall strictly implement this Code.

Where pharmaceutical production enterprises sell drugs and drugs in the process of circulation and other drugs involved in the storage and transportation, they shall also comply with the relevant requirements of this code.

Article 4 A pharmaceutical trading enterprise shall adhere to honesty and trustworthiness and operate according to law. Any false or deceptive behavior is prohibited.

Chapter II Quality Management of Pharmaceutical Wholesale

Section 1 Quality Management System

Article 5 An enterprise shall establish a quality management system in accordance with the relevant laws and regulations and the requirements of this code, determine the quality policy, 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 the enterprise shall clarify the overall quality objectives and requirements of the enterprise and implement the entire process of pharmaceutical business activities.

Article 7 The enterprise quality management system shall be compatible with its business scope and scale, including organization, personnel, facilities and equipment, quality management system documents and corresponding computer systems.

Article 8 An enterprise shall organize internal audits on a regular basis and when major changes occur in the key elements of the quality management system.

Article 9 An enterprise shall analyze the internal audit situation, formulate corresponding quality management system improvement measures based on 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 adopt a forward-looking or retrospective approach to evaluate, control, communicate and audit the quality risks in the process of drug circulation.

Article 11 An enterprise shall evaluate the quality management system of the drug supplier unit and the purchase unit, confirm its quality assurance capability and quality reputation, and conduct on-the-spot investigation if necessary.

Article 12 Enterprises shall participate in quality management. All departments and positions 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 establish an organization or position that is compatible with its business activities and quality management, and clearly stipulate its duties, authorities and mutual relations.

Article 14 The person in charge of the enterprise is the main responsible person of the quality of the drug, is responsible for the daily management of the enterprise, and is responsible for providing the necessary conditions to ensure that the quality management department and the quality management personnel perform their duties effectively, ensuring that the enterprise achieves the quality objectives and operates in accordance with the requirements of this code. drug.

Article 15 The person in charge of the quality of the enterprise shall be the senior management personnel, be responsible for the overall quality management of the drug, perform the duties independently, and have the power to decide on the quality management of the drug within the enterprise.

Article 16 An enterprise shall establish a quality management department to effectively carry out quality management work. The duties of the quality management department shall not be performed by other departments and personnel.

Article 17 The quality management department shall perform the following duties:

(1) Supervising and urging relevant departments and post personnel to implement laws and regulations on drug administration and this Code;

(2) Organizing the formulation of quality management system documents and guiding and supervising the implementation of documents;

(3) Responsible for reviewing the legality of the supplier and the purchaser, the legality of the purchased drugs, and the legal qualifications of the sales personnel of the supplier and the purchasing personnel of the purchaser, and dynamically managing according to the changes in the audit contents;

(4) Responsible for the collection and management of quality information and the establishment of drug quality files;

(5) Responsible for the acceptance of drugs, and guide and supervise the quality management of drug procurement, storage, maintenance, sales, returns, transportation, etc.;

(6) Responsible for the confirmation of unqualified drugs and supervising the handling of unqualified drugs;

(7) Responsible for the investigation, handling and reporting of drug quality complaints and quality accidents;

(8) Reporting on counterfeit and inferior drugs;

(9) Responsible for inquiring about drug quality;

(10) Responsible for guiding and setting the quality control function of the computer system;

(11) Responsible for the auditing of computer system operation authority and the establishment and update of basic data of quality management;

(12) Organizing verification and calibration of relevant facilities and equipment;

(13) Responsible for the management of drug recalls;

(14) Responsible for reporting adverse drug reactions;

(15) Internal audit and risk assessment of the organization's quality management system;

(16) Organizing an investigation and evaluation of the quality management system and service quality of drug suppliers and purchasers;

(17) Organizing the review of the carrier's transportation conditions and quality assurance capabilities for the entrusted transportation;

(18) Assist in quality management education and training;

(19) Other duties that should be performed by the quality management department.

Section III Staff and Training

Article 18 The personnel engaged in pharmaceutical business and quality management shall comply with the relevant laws and regulations and the qualification requirements stipulated in this code, and shall not be prohibited by relevant laws and regulations.

Article 19 The person in charge of the enterprise shall have a college degree or above or a professional title of intermediate or above. After basic pharmacy professional knowledge training, be familiar with the laws and regulations related to drug administration and this code.

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

Article 21 The person in charge of the quality management department of an enterprise shall have the qualifications of a licensed pharmacist and more than 3 years of experience in the management of quality of pharmaceutical products, and be able to independently solve the quality problems in the course of business operations.

Article 22 An enterprise shall be equipped with personnel in quality management, inspection and maintenance, etc. that meet the following qualification requirements:

(1) Those engaged in quality management shall have a bachelor's degree or above in pharmacy or a major in medicine, biology or chemistry, or a professional title with pharmacy above primary level;

(2) Those who are engaged in the inspection and maintenance work shall have a secondary school degree or above in pharmacy or medicine, biology, chemistry or other related majors or a professional technical title with pharmacy above primary level;

(3) Those who are engaged in the acceptance work of Chinese herbal medicines and Chinese medicine decoction pieces shall have a secondary school degree or above with a Chinese medicine major or a professional technical title with a middle or higher level of Chinese medicine; if they are engaged in the maintenance of Chinese herbal medicines or Chinese medicine decoction pieces, they shall have a secondary secondary school or above in Chinese medicine. Academic qualifications or professional titles with above-level professional pharmacy; directly purchasing real estate Chinese herbal medicines, the acceptance personnel should have the professional technical titles above the intermediate level of Chinese pharmacy.

Enterprises that operate vaccines should also be equipped with more than 2 professional technicians who are responsible for vaccine quality management and acceptance. Professional and technical personnel should have bachelor degree or above in intermediates such as preventive medicine, pharmacy, microbiology or medicine, and professional titles of intermediate and above. More than 3 years experience in vaccine management or technical work.

Article 23 Personnel engaged in quality management and inspection and acceptance shall be employed on-the-job and shall not work part-time in other businesses.

Article 24 Personnel engaged in procurement work shall have a secondary education or above in pharmacy or medicine, biology, chemistry, etc., and those engaged in sales, storage, etc. shall have a high school education or above.

Article 25 An enterprise shall conduct pre-job training and continuing training related to its duties and work contents for each post to meet the requirements of this specification.

Article 26 The training content shall include relevant laws and regulations, pharmaceutical professional knowledge and skills, quality management system, responsibilities and job procedures.

Article 27 An enterprise shall formulate an annual training plan and conduct training in accordance with the training management system so that relevant personnel can correctly understand and perform their duties. Training should be well documented and archived.

Article 28 Personnel engaged in the storage and transportation of specially-managed drugs and chilled frozen drugs shall be trained in relevant laws, regulations and professional knowledge and may pass the examination before they can be employed.

Article 29 An enterprise shall formulate a personal hygiene management system for employees, and the dressing of personnel in storage, transportation, etc. shall meet the requirements for labor protection and product protection.

Article 30 Personnel in direct contact with pharmaceuticals such as quality management, inspection, maintenance, storage, etc. shall conduct pre-job and annual health checks and establish health records. Those who suffer 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 position, it shall not engage in related work.

Section IV Quality Management System Document

Article 31 The establishment of a quality management system document by an enterprise shall conform to the actual situation of the enterprise. Documents include quality management systems, departmental and job responsibilities, operational procedures, files, reports, records and vouchers.

Article 32 The drafting, revision, review, approval, distribution, custody, and modification, cancellation, replacement, and destruction of documents shall be conducted in accordance with the document management operation procedures and relevant records shall be kept.

Article 33 The document shall indicate the title, type, purpose, and document number and version number. The text should be accurate, clear and easy to understand. Documents should be stored separately for easy access.

Article 34 An enterprise shall review and revise documents on a regular basis. The documents used shall be the current valid texts. Documents that have been abolished or invalidated shall not appear on the job site unless they are kept on file.

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

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

(1) The provisions of the internal audit of the quality management system;

(2) the provisions of the quality veto;

(3) Management of quality management documents;

(4) Management of quality information;

(5) Provisions for the qualification examination of the supplier unit, the purchase unit, the sales unit of the supplier unit and the purchaser of the purchase unit;

(6) Management of drug procurement, receipt, acceptance, storage, maintenance, sales, delivery, and transportation;

(7) Provisions for specially managed drugs;

(8) Management of the validity period of the drug;

(9) Management of the destruction of unqualified drugs and drugs;

(10) Management of drug returns;

(11) Management of drug recalls;

(12) Management of quality inquiry;

(13) Management of quality accidents and quality complaints;

(14) The provisions of the adverse drug reaction report;

(15) Provisions on environmental sanitation and personnel health;

(16) Provisions on education, training and assessment of quality;

(17) Management of the storage and maintenance of facilities and equipment;

(18) Management of facility equipment verification and calibration;

(19) Management of records and vouchers;

(20) Management of computer systems;

(21) The implementation of the electronic regulation of drugs;

(22) Other content that should be specified.

Article 37 The duties of departments and posts shall include:

(1) Responsibilities of quality management, procurement, storage, sales, transportation, finance and information management;

(2) Responsibilities of the person in charge of the enterprise, the person in charge of quality, and the person in charge of quality management, procurement, storage, sales, transportation, finance, and information management;

(3) Responsibilities for quality management, procurement, receipt, acceptance, storage, maintenance, sales, warehouse review, transportation, finance, information management;

(4) Other duties related to pharmaceutical business.

Article 38 An enterprise shall formulate procedures for the procurement, receipt, acceptance, storage, maintenance, sale, re-examination, transportation, and computer systems of pharmaceuticals.

Article 39 An enterprise shall establish relevant records such as drug procurement, acceptance, maintenance, sales, warehouse review, post-sale return and purchase and withdrawal, transportation, storage and transportation temperature and humidity monitoring, and unqualified drug treatment, so as to be true, complete and accurate. Effective and traceable.

Article 40 When recording data through a computer system, the relevant personnel shall log in or review the data according to the operation rules and after registering with the authorization and password; the data change shall be reviewed by the quality management department and conducted under the supervision of the quality management department. There should be a record.

Article 41 The written records and vouchers shall be filled out in a timely manner, and the writing shall be clear and shall not be altered or smashed. If the record is changed, the reason, date and signature shall be indicated to keep the original information clear and identifiable.

Article 42 Records and vouchers shall be kept for at least 5 years. Records and vouchers for vaccines and specially administered drugs are kept in accordance with relevant regulations.

Section 5 Facilities and Equipment

Article 43 An enterprise shall have business premises and warehouses that are compatible with its business scope and scale of operation.

Article 44 The site selection, design, layout, construction, renovation and maintenance of the warehouse shall comply with the requirements for drug storage and prevent contamination, cross-contamination, confusion and errors of the drug.

Article 45 The drug storage operation area and auxiliary operation area shall be separated from the office area and living area by a certain distance or have isolation measures.

Article 46 The scale and conditions of the warehouse shall meet the reasonable and safe storage of the medicines and meet the following requirements to facilitate the storage operation:

(1) The environment inside and outside the warehouse is clean and tidy, there is no pollution source, and the ground in the reservoir area is hardened or greened;

(2) The inner wall of the warehouse, the top and the clean, the ground is flat, and the structure of the doors and windows is strict;

(3) The warehouse has reliable safety protection measures, which can implement controlled management of unrelated personnel to prevent theft, replacement or mixing of counterfeit drugs;

(4) Measures to prevent outdoor loading, unloading, handling, receiving, and shipping operations from being affected by abnormal weather.

Article 47 The warehouse shall be equipped with the following facilities and equipment:

(1) Equipment that is effectively isolated between the drug and the ground;

(2) Equipment that is protected from light, ventilation, moisture, insects, and rodents;

(3) Equipment for effectively regulating temperature and humidity and indoor and outdoor air exchange;

(4) Equipment for automatically monitoring and recording the temperature and humidity of the warehouse;

(5) Lighting equipment that meets the requirements for storage operations;

(6) Working areas and equipment used for scrap picking, LCL delivery and review;

(7) Storage place of packaging materials;

(8) Special places for acceptance, delivery and return;

(9) Special storage places for unqualified drugs;

(10) The special management drugs shall have storage facilities in accordance with state regulations.

Article 48 Anyone who operates Chinese herbal medicines or Chinese herbal medicines shall have a dedicated warehouse and maintenance work place. The Chinese medicine sample room (cabinet) shall be set up when directly purchasing real estate Chinese herbal medicines.

Article 49 The following facilities and equipment shall be provided for the operation of refrigerated or frozen medicines:

(1) A cold storage that is compatible with its scale and variety of operations, and two or more independent cold storages should be provided for the operation of vaccines;

(2) Equipment for automatic monitoring, display, recording, regulation and alarm of cold storage temperature;

(3) Cold storage system