No. 90

The "Good Supply Practice for Pharmaceutical Products" was reviewed and approved by the Ministry of Health's ministerial meeting on November 6, 2012, and is hereby promulgated, effective from June 1, 2013.

Minister Chen Zhu

January 22, 2013

Good Supply Practice for Pharmaceutical Products

Chapter 1 General Provisions

Article 1 These practices are formulated in accordance with the "Pharmaceutical Administration Law of the People's Republic of China" and the "Regulations for the Implementation of the Pharmaceutical Administration Law of the People's Republic of China" to strengthen quality management in pharmaceutical operations, regulate pharmaceutical business conduct, and ensure the safety and efficacy of human medication.

Article 2 These practices are the basic guidelines for pharmaceutical operation management and quality control. Enterprises shall adopt effective quality control measures in the procurement, storage, sales, transportation, and other links of pharmaceutical products to ensure drug quality.

Article 3 Pharmaceutical operating enterprises shall strictly implement these practices.

Pharmaceutical manufacturing enterprises selling drugs and other parties involved in the storage and transportation of drugs during the drug circulation process shall also comply with the relevant requirements of these practices.

Article 4 Pharmaceutical operating enterprises shall adhere to honesty and trustworthiness and operate in accordance with the law. Any false or deceptive behavior is prohibited.

Chapter 2 Quality Management of Pharmaceutical Wholesale

Section 1 Quality Management System

Article 5 Enterprises shall establish a quality management system in accordance with relevant laws and regulations and the requirements of these practices, define 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 enterprises shall clearly define the overall quality objectives and requirements of the enterprise and be implemented throughout the entire process of pharmaceutical operations.

Article 7 The enterprise quality management system shall be adapted to its scope and scale of operation, including organizational structure, personnel, facilities and equipment, quality management system documents, and corresponding computer systems.

Article 8 Enterprises shall organize internal audits regularly and when significant changes occur in key elements of the quality management system.

Article 9 Enterprises shall analyze the results of internal audits, formulate corresponding quality management system improvement measures based on the analysis conclusions, continuously improve the level of quality control, and ensure the continuous effective operation of the quality management system.

Article 10 Enterprises shall assess, control, communicate, and review quality risks in the drug circulation process in a proactive or retrospective manner.

Article 11 Enterprises shall evaluate the quality management systems of drug suppliers and purchasers, confirm their quality assurance capabilities and quality reputation, and conduct on-site inspections when necessary.

Article 12 Enterprises shall involve all personnel in quality management. Personnel in various departments and positions shall correctly understand and perform their duties and assume corresponding quality responsibilities.

Section 2 Organizational Structure and Quality Management Responsibilities

Article 13 Enterprises shall establish an organizational structure or positions suitable for their business activities and quality management, clearly defining their responsibilities, authorities, and interrelationships.

Article 14 The enterprise principal is the primary responsible person for drug quality, fully responsible for the enterprise's daily management, responsible for providing necessary conditions to ensure that the quality management department and quality management personnel effectively perform their duties, and ensuring that the enterprise achieves quality objectives and operates drugs in accordance with the requirements of these practices.

Article 15 The enterprise quality supervisor shall be a senior management personnel, fully responsible for drug quality management, independently perform duties, and have the right to arbitrate on drug quality management within the enterprise.

Article 16 Enterprises shall establish a quality management department to effectively carry out quality management work. The responsibilities of the quality management department shall not be performed by other departments or personnel.

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

(1) Urge relevant departments and personnel to implement laws, regulations, and these practices regarding drug administration;

(2) Organize the formulation of quality management system documents, and guide and supervise their implementation;

(3) Be responsible for reviewing the legality of suppliers and purchasers, the legality of purchased drugs, and the legal qualifications of suppliers' sales personnel and purchasers' procurement personnel, and manage them dynamically according to changes in review content;

(4) Be responsible for the collection and management of quality information, and establish drug quality archives;

(5) Be responsible for drug acceptance, and guide and supervise quality management work in drug procurement, storage, maintenance, sales, returns, transportation, and other links;

(6) Be responsible for the confirmation of unqualified drugs and supervise the handling process of unqualified drugs;

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

(8) Be responsible for reporting counterfeit and substandard drugs;

(9) Be responsible for drug quality inquiries;

(10) Be responsible for guiding the setting of computer system quality control functions;

(11) Be responsible for reviewing computer system operating permissions and establishing and updating quality management basic data;

(12) Organize the verification and calibration of relevant facilities and equipment;

(13) Be responsible for the management of drug recalls;

(14) Be responsible for reporting adverse drug reactions;

(15) Organize internal audits and risk assessments of the quality management system;

(16) Organize inspections and evaluations of the quality management systems and service quality of drug suppliers and purchasers;

(17) Organize the review of the transportation conditions and quality assurance capabilities of entrusted carriers;

(18) Assist in carrying out quality management education and training;

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

Section 3 Personnel and Training

Article 18 Personnel engaged in drug operation and quality management activities shall meet the qualification requirements stipulated by relevant laws, regulations, and these practices, and shall not be in situations prohibited from employment by relevant laws and regulations.

Article 19 The enterprise principal shall have a college degree or above, or an intermediate or above professional technical title, have received basic pharmaceutical professional knowledge training, and be familiar with relevant drug administration laws, regulations, and these practices.

Article 20 The enterprise quality supervisor shall have a bachelor's degree or above, a licensed pharmacist qualification, and at least 3 years of experience in drug operation quality management, and possess the ability to make correct judgments and ensure implementation in quality management work.

Article 21 The person in charge of the enterprise's quality management department should have a licensed pharmacist qualification and more than 3 years of experience in drug business quality management, and be able to independently resolve quality issues during business operations.

Article 22 The enterprise should staff positions such as quality management, acceptance, and maintenance with personnel who meet the following qualification requirements:

(1) Personnel engaged in quality management should have a pharmaceutical secondary specialized school degree or a college degree or above in related majors such as medicine, biology, or chemistry, or possess a junior or higher professional technical title in pharmacy;

(2) Personnel engaged in acceptance and maintenance should have a pharmaceutical secondary specialized school degree or above in related majors such as medicine, biology, or chemistry, or possess a junior or higher professional technical title in pharmacy;

(3) Personnel engaged in the acceptance of traditional Chinese medicinal materials and decoction pieces should have a secondary specialized school degree or above in traditional Chinese medicine, or possess an intermediate or higher professional technical title in traditional Chinese medicine; personnel engaged in the maintenance of traditional Chinese medicinal materials and decoction pieces should have a secondary specialized school degree or above in traditional Chinese medicine, or possess a junior or higher professional technical title in traditional Chinese medicine; for direct acquisition of locally produced traditional Chinese medicinal materials, acceptance personnel should have an intermediate or higher professional technical title in traditional Chinese medicine.

Enterprises operating vaccines should also be equipped with at least 2 professional technical personnel specifically responsible for vaccine quality management and acceptance. These professional technical personnel should have a bachelor's degree or above in preventive medicine, pharmacy, microbiology, or medicine, as well as an intermediate or higher professional technical title, and have more than 3 years of experience in vaccine management or technical work.

Article 23 Personnel engaged in quality management and acceptance work should be on duty at their posts and should not hold other business positions concurrently.

Article 24 Personnel engaged in procurement should have a pharmaceutical secondary specialized school degree or above in related majors such as medicine, biology, or chemistry, and personnel engaged in sales, storage, and other related work should have a high school education or above.

Article 25 The enterprise should provide pre-job training and continuous training for personnel in all positions relevant to their responsibilities and work content, to meet the requirements of these specifications.

Article 26 Training content should include relevant laws and regulations, professional knowledge and skills in pharmaceuticals, quality management systems, responsibilities, and standard operating procedures for positions.

Article 27 The enterprise should formulate annual training plans and conduct training in accordance with the training management system, enabling relevant personnel to correctly understand and fulfill their duties. Training work should be properly recorded and archived.

Article 28 Personnel engaged in the storage and transportation of specially managed drugs and refrigerated/frozen drugs should undergo training in relevant laws, regulations, and professional knowledge, and only after passing the assessment can they be employed.

Article 29 The enterprise should establish an employee personal hygiene management system. The attire of personnel in storage, transportation, and other positions should meet the requirements for labor protection and product protection.

Article 30 Personnel in positions directly handling drugs, such as quality management, acceptance, maintenance, and storage, should undergo pre-job and annual health checks, and health records should be established. Those suffering from infectious diseases or other diseases that may contaminate drugs are not permitted to work in direct contact with drugs. Personnel whose physical conditions do not meet the specific requirements of the corresponding positions are not permitted to engage in related work.

Section 4 Quality Management System Documents

Article 31 The quality management system documents formulated by the enterprise should be consistent with the enterprise's actual situation. Documents include quality management systems, departmental and position responsibilities, operating procedures, archives, reports, records, and vouchers.

Article 32 The drafting, revision, review, approval, distribution, custody, as well as modification, revocation, replacement, and destruction of documents should be carried out in accordance with document management operating procedures, and relevant records should be kept.

Article 33 Documents should clearly indicate the title, type, purpose, document number, and version number. The text should be accurate, clear, and easy to understand.

Documents should be classified and stored for easy retrieval.

Article 34 The enterprise should regularly review and revise documents. The documents in use should be current and valid versions. Obsolete or invalid documents, except for those archived for reference, should not appear at the work site.

Article 35 The enterprise should ensure that all positions have access to the necessary documents corresponding to their work content and should strictly carry out work according to regulations.

Article 36 The quality management system should include the following:

(1) Provisions for internal audits of the quality management system;

(2) Provisions for quality veto power;

(3) Management of quality management documents;

(4) Management of quality information;

(5) Provisions for qualification review of suppliers, purchasers, sales personnel of suppliers, and purchasing personnel of purchasers;

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

(7) Provisions for specially managed drugs;

(8) Management of drug expiry dates;

(9) Management of unqualified drugs and drug destruction;

(10) Management of drug returns;

(11) Management of drug recalls;

(12) Management of quality inquiries;

(13) Management of quality accidents and quality complaints;

(14) Provisions for adverse drug reaction reporting;

(15) Provisions for environmental hygiene and personnel health;

(16) Provisions for quality-related education, training, and assessment;

(17) Management of facility and equipment custody and maintenance;

(18) Management of facility and equipment validation and calibration;

(19) Management of records and vouchers;

(20) Management of computer systems;

(21) Provisions for implementing electronic drug supervision;

(22) Other necessary provisions.

Article 37 Departmental and position responsibilities should include:

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

(2) Position responsibilities of the enterprise's principal, quality principal, and department heads for quality management, procurement, storage, sales, transportation, finance, and information management;

(3) Position responsibilities for quality management, procurement, receipt, acceptance, storage, maintenance, sales, outbound review, transportation, finance, information management, and other related positions.

(4) Other job responsibilities related to drug operations.

Article 38 Enterprises shall formulate operating procedures for drug procurement, receiving, acceptance, storage, maintenance, sales, outbound review, transportation, and computer systems.

Article 39 Enterprises shall establish relevant records for drug procurement, acceptance, maintenance, sales, outbound review, post-sale returns and purchase returns, transportation, storage and transportation temperature and humidity monitoring, and handling of unqualified drugs, ensuring they are true, complete, accurate, effective, and traceable.

Article 40 When recording data through a computer system, relevant personnel shall log in with authorization and password according to operating procedures before entering or reviewing data; data changes shall be reviewed by the quality management department and carried out under its supervision, and the change process shall be recorded.

Article 41 Written records and vouchers shall be filled in promptly, with clear handwriting, and shall not be arbitrarily altered or torn up. If records are changed, the reason, date, and signature shall be noted, and the original information shall remain clearly legible.

Article 42 Records and vouchers shall be kept for at least 5 years. Records and vouchers for vaccines and specially managed drugs shall be kept according to relevant regulations.

Section 5 Facilities and Equipment

Article 43 Enterprises shall have business premises and warehouses commensurate with their drug business scope and operating scale.

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

Article 45 Drug storage operating areas and auxiliary operating areas shall be separated from office and living areas by a certain distance or have isolation measures.

Article 46 The scale and conditions of the warehouse shall meet the requirements for reasonable and safe drug storage and achieve the following requirements to facilitate storage operations:

(1) The internal and external environment of the warehouse shall be clean, free of pollution sources, and the warehouse area floor shall be hardened or greened;

(2) The inner walls and ceiling of the warehouse shall be smooth, the floor flat, and the doors and windows tightly structured;

(3) The warehouse shall have reliable security protection measures to control unauthorized personnel access and prevent drugs from being stolen, replaced, or mixed with counterfeit drugs;

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

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

(1) Equipment for effective isolation between drugs and the ground;

(2) Equipment for light protection, ventilation, moisture proofing, insect control, and rodent control;

(3) Equipment for effective temperature and humidity control and indoor/outdoor air exchange;

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

(5) Lighting equipment that meets storage operation requirements;

(6) Operating areas and equipment for picking loose items, consolidating shipments, and review;

(7) Storage areas for packaging materials;

(8) Dedicated areas for acceptance, dispatch, and returns;

(9) Dedicated storage areas for unqualified drugs;

(10) For operations involving specially managed drugs, storage facilities that comply with national regulations shall be in place.

Article 48 Enterprises operating Chinese medicinal materials and prepared slices of Chinese crude drugs shall have dedicated warehouses and maintenance workplaces. Those directly purchasing locally produced Chinese medicinal materials shall set up Chinese medicine sample rooms (cabinets).

Article 49 Enterprises operating refrigerated or frozen drugs shall be equipped with the following facilities and equipment:

(1) Cold storage facilities commensurate with their operating scale and variety. Those operating vaccines shall be equipped with two or more independent cold storage facilities;

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

(3) Standby generator sets or dual-circuit power supply systems for cold storage refrigeration equipment;

(4) For drugs with special low-temperature requirements, facilities and equipment meeting their storage requirements shall be provided;

(5) Refrigerated vehicles and in-vehicle refrigerated boxes or insulated containers and other equipment.

Article 50 Drugs shall be transported using enclosed cargo transport vehicles.

Article 51 Refrigerated vehicles and in-vehicle refrigerated boxes or insulated containers for transporting refrigerated and frozen drugs shall comply with the temperature control requirements during drug transportation. Refrigerated vehicles shall have functions for automatic temperature control, temperature display, and storing and reading temperature monitoring data; refrigerated boxes and insulated containers shall have functions for external display and collecting temperature data inside the box.

Article 52 Regular inspection, cleaning, and maintenance of storage and transportation facilities and equipment shall be the responsibility of a designated person, and records and archives shall be established.

Section 6 Calibration and Verification

Article 53 Enterprises shall regularly calibrate or verify measuring instruments, temperature and humidity monitoring equipment, etc., in accordance with relevant national regulations.

Enterprises shall concerning cold storage facilities, storage and transportation temperature and humidity monitoring systems, and refrigerated transport