Good Supply Practice for Drugs

Good Supply Practice for Drugs

(Issued in Decree No. 20 of former CFDA on April 30, 2000, first revision in ministerial meeting of former Ministry of Health on November 6, 2012, second revision in the executive meeting of former CFDA on May 18, 2015, and amended according to the Decision to Amend the Good Supply Practice for Drugs of former CFDA on June 30, 2016)

Chapter I General Provisions

Article 1 To strengthen quality management of drug distribution, standardize drug distribution activities, and guarantee safe and effective use of drugs on human body, the Good Supply Practice for Drugs (GSP) is formulated in accordance with the Drug Administration Law of the People's Republic of China and the Regulations for Implementation of the Drug Administration Law of the People's Republic of China.

Article 2 The GSP provides general principles for drug distribution management and quality control.

Enterprises shall take effective quality control measures in drug purchase, storage, sales and transportation to ensure the quality of drugs, and establish a drug traceability system in accordance with the relevant requirements of the State to achieve drug traceability.

Article 3 Drug distributors shall strictly implement the GSP.

Drug sales conducted by drug manufacturers and drug storage as well as transportation involved in the process of drug circulation, shall meet relevant requirements of the GSP.

Article 4 Drug distributors shall be honest and trustworthy, and carry out the business practices legally. Any spurious or deceptive behaviors are forbidden.

Chapter II Quality Management of Drug Wholesale

Section 1 Quality Management System

Article 5 Enterprises shall, in accordance with relevant laws and regulations and requirements of the GSP, establish the quality management system, determine the quality policy, formulate documents of the quality management system, and carry out activities such as quality planning, quality control, quality assurance, quality improvement and quality risk management.

Article 6 Quality policy documents formulated by an enterprise shall clearly define the overall quality objectives and requirements of the enterprise, which shall be implemented throughout the whole process of drug commercial activities.

Article 7 The quality management system of an enterprise shall be commensurate with its business scope and scale, including organizational structure, personnel, facilities and equipment, documents of the quality management system and corresponding computer system, etc.

Article 8 Enterprises shall organize the internal audit on a regular basis and when there is any significant change of key elements of the quality management system.

Article 9 Enterprises shall analyze the information of internal audit, formulate corresponding improvement measures for the quality management system based on the analysis conclusion, constantly improve the quality control level, and ensure the continuous and effective operation of the quality management system.

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

Article 11 Enterprises shall evaluate the quality management system of drug supplier and purchaser to confirm their quality assurance capability and quality credit, and conduct field investigation when necessary.

Article 12 Enterprises shall have all their employees involved in quality management. Personnel of all departments and posts shall correctly understand and perform their duties and assume corresponding quality responsibilities.

Section 2 Organizational Structure and Quality Management Responsibilities

Article 13 Enterprises shall set up an organization or posts corresponding to their distribution activities and quality management and clearly define their duties, authorities and relations with each other.

Article 14 The responsible person of an enterprise is the principal person in charge of drug quality, takes full responsibilities for daily management of the enterprise and provides necessary conditions to ensure that the quality management department or quality management personnel effectively fulfill the responsibilities and that the enterprise realizes quality objectives and handles drugs according to the requirements in this GSP.

Article 15 The quality responsible person of an enterprise shall be the senior management, who takes full responsibility for the quality management of drugs, independently fulfills his/her responsibilities, and has authority over the quality management of drugs within the enterprise.

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

Article 17 The quality management department shall fulfill the following responsibilities:

(I) Urging relevant departments and post holders to implement drug administration laws and regulations as well as this GSP;

(II) Organizing the formulation of quality management system documents, and guiding and supervising the implementation thereof;

(III) Auditing the legal qualification of supplier and purchaser, the legality of drugs purchased and the legal qualification of sales personnel of supplier and purchasing personnel of purchaser, and conducting dynamic management according to the changes of audit contents;

(IV) Collecting and managing quality information, and establishing drug quality archives;

(V) Carrying out acceptance inspection of drugs, and guiding and supervising the quality management in drug purchase, storage, maintenance, sales, return and transportation;

(VI) Validating unqualified drugs, and supervising the handling thereof;

(VII) Being responsible for investigation, handling and reporting of quality complaints and quality accidents of drugs;

(VIII) Reporting of substandard or falsified drugs;

(IX) Inquiring drug quality;

(X) Guiding the setting of quality control function of the computer system;

(XI) Being responsible for the audit of operation permission of computer system, and the establishment and update of basic data of quality management;

(XII) Organizing the validation and calibration of relevant facilities and equipment;

(XIII) Being responsible for the management of drug recalls;

(XIV) Reporting of adverse drug reactions (ADRs);

(XV) Organizing the internal audit and risk assessment of the quality management system;

(XVI) Organizing the inspection and evaluation of the quality management system and service quality of drug supplier and purchaser;

(XVII) Organizing the review on the transportation conditions and quality assurance ability of the carrier entrusted with transportation services;

(XVIII) Assisting in carrying out quality management education and training;

(XIX) Other responsibilities that shall be fulfilled by the quality management department.

Section 3 Personnel and Training

Article 18 The personnel engaged in drug distribution and quality management of an enterprise shall comply with the qualification requirements specified in relevant laws and regulations and this GSP, and shall be under no Job Forbidden by relevant laws and regulations.

Article 19 The responsible person of an enterprise shall have a college degree or above, or an intermediate professional and technical title or above, have received basic training on professional pharmaceutical knowledge and be familiar with drug administration laws and regulations as well as this GSP.

Article 20 The quality responsible person of an enterprise shall have a bachelor's degree or above, a pharmacist's license, working experiences in quality management of drug distribution for more than 3 years, and the ability to make correct judgments and ensure the implementation of quality management.

Article 21 The responsible person of the quality management department of an enterprise shall have the pharmacist's license and working experiences in quality management of drug distribution for more than 3 years, and be able to solve quality issues in the process of drug distribution independently.

Article 22 Enterprises shall be equipped with personnel for quality management, acceptance inspection and maintenance who meet the following qualification requirements:

(I) Personnel engaged in quality management shall have a degree of technical school in pharmacy, or college degree or above in medicine, biology and chemistry, or primary professional and technical title or above in pharmacy;

(II) Personnel engaged in acceptance inspection and maintenance shall have a degree of technical school or above in pharmacy or medicine, biology, chemistry or other related disciplines, or a primary professional and technical title or above in pharmacy;

(III) Personnel engaged in the acceptance inspection of Chinese crude drugs and Prepared Slices shall have a degree of technical school or above or an intermediate professional and technical title or above in traditional Chinese medicine; those engaged in the maintenance of Chinese crude drugs and Prepared Slices shall have a degree of technical school or above or a primary professional and technical title or above in traditional Chinese medicine; for the direct purchase of Chinese crude drugs at the place of production, the acceptance inspection personnel shall have the intermediate professional title or above in traditional Chinese medicine.

For the dispatch of vaccines, there shall be at least two professionals especially responsible for the quality management and acceptance inspection of vaccines. Professionals shall have a bachelor's degree or above and intermediate professional and technical title or above in preventive medicine, pharmacy, microbiology or medicine, and have working experiences in vaccine management or techniques for more than 3 years.

Article 23 The personnel engaged in quality management and acceptance inspection shall be in service and on duty, and shall not take other part-time business job.

Article 24 Purchasing personnel shall have a degree of technical school or above in pharmacy or medicine, biology, chemistry and other related disciplines, and sales or storage personnel shall have a degree of senior high school or above.

Article 25 Enterprises shall carry out pre-post training and on-the-job training related to the responsibilities and job contents for all post holders so as to ensure compliance with this GSP.

Article 26 The training content shall contain applicable laws and regulations, professional knowledge and skills on drugs, quality management system, responsibilities as well as post operating procedures.

Article 27 Enterprises shall, in accordance with the training management system, formulate annual training plans and carry out training so that relevant personnel can correctly understand and perform their duties. Training shall be well documented and related archives shall be established.

Article 28 Personnel engaged in the storage and transportation of drugs under special management and refrigerated and frozen drugs shall have received the training on relevant laws and regulations and professional knowledge, and shall not take up their posts until passing the assessment.

Article 29 Enterprises shall formulate a personal hygiene management system for employees. The dressing of the personnel responsible for storage and transportation shall conform to the requirements for labor protection and product protection.

Article 30 Personnel responsible for quality control, acceptance inspection, maintenance and storage and other posts in direct contact with drugs shall undergo pre-post and annual health examinations, and have health records established. Personnel suffering from infectious diseases or other diseases that could contaminate drugs shall not engage in the work in which they could directly contact the drugs. Personnel whose physical conditions do not meet the specific requirements of corresponding posts shall not be allowed to engage in relevant work.