Good Supply Practice for Pharmaceutical Products
Good Supply Practice for Pharmaceutical Products
Good Supply Practice for Pharmaceutical Products
Order of the China Food and Drug Administration No.13
June 25, 2015
The Good Supply Practice for Pharmaceutical Products, deliberated and adopted at the executive meeting of the China Food and Drug Administration on May 18, 2015, is hereby promulgated and shall take effect as of the date of promulgation.
Bi Jingquan, Minister
Good Supply Practice for Drugs
Chapter I General Provisions
Article 1 For the purposes of strengthening the quality management of drug distribution, regulating drug distribution behaviors and ensuring the safety and effectiveness of drugs for human use, the Good Supply Practice for Pharmaceutical Products (hereinafter referred to as the "Practice") is formulated in accordance with the Drug Administration Law of the People's Republic of China and the Implementing Regulations of the Drug Administration Law of the People's Republic of China.
Article 2 The Practice comprises a set of basic standards for drug distribution management and quality control, and enterprises shall take effective measures for quality control in such links as the purchase, storage, sales and transportation of drugs to ensure the quality of drugs.
Article 3 Drug distributors shall strictly implement the Practice.
The sales of drugs by drug manufacturers and other activities concerning the storage and transportation of drugs during the circulation process of drugs shall also conform to relevant requirements of the Practice.
Article 4 Drug distributors shall uphold honesty and trustworthiness, and carry out business in accordance with the law. Any false or fraudulent act is prohibited.
Chapter II Quality Management for Wholesale of Pharmaceutical Products
Section 1 Quality Management System
Article 5 Enterprises shall, pursuant to relevant laws and regulations as well as the requirements of the Practice, establish quality management systems, determine quality policies, formulate quality management system documents, and carry out quality planning, quality control, quality assurance, quality improvement, quality risk management and other activities.
Article 6 Quality policy documents formulated by enterprises shall specify the overall quality objectives and requirements of the enterprises, and shall be carried out throughout the whole process of operation activities relating to drugs.
Article 7 The quality management system of an enterprise shall be adapted to its business scope and scale, and includes organizations, personnel, facilities and equipment, quality management system documents and corresponding computer system.
Article 8 An enterprise shall organize and carry out the internal audit on a regular basis and at the time when key elements of the quality management system undergo major changes.
Article 9 An enterprise shall analyze the information of the internal audit, and formulate corresponding improvement measures for the quality management system according to the analysis conclusions, so as to constantly improve the level of quality control and ensure the continuous and effective operation of the quality management system.
Article 10 An enterprise shall assess, control, communicate about, examine and verify quality risks in the process of drug circulation by means of forecasting or retrospection.
Article 11 Enterprises shall evaluate quality management systems of drug suppliers and drug purchasers to confirm their quality assurance capabilities and quality credibility, and conduct on-the-spot investigation when necessary.
Article 12 All the staff members of an enterprise shall participate in the quality management. The personnel of all departments and at all posts shall correctly understand and perform their duties, and bear corresponding quality responsibilities.
Section 2 Organizations and Quality Management Duties
Article 13 An enterprise shall set up organizations or posts that suit its operating activities and quality management, and clearly define their duties, authorities and interrelationships.
Article 14 The person in charge of an enterprise is the main person liable for drug quality, takes full charge of the daily management of the enterprise, and is responsible for providing necessary conditions to guarantee the effective performance of duties by quality management department and quality management personnel, in a bid to ensure that the enterprise achieves its quality objectives and distributes drugs according to the requirements of the Practice.
Article 15 The person responsible for the quality in an enterprise shall be a senior officer, takes full charge of the drug quality management, performs his duties independently and has the discretion on drug quality management within the enterprise.
Article 16 An enterprise shall set up a quality management department to carry out quality management work effectively. 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. supervise and urge the personnel of the relevant departments and posts to implement laws and regulations on drug management and the Practice;
2. organize the formulation of quality management system documents, and guide and supervise the implementation thereof;
3. be responsible for examining and verifying the legality of suppliers and purchasers, the legality of drugs purchased, and legal qualifications of sales personnel of suppliers and procurement personnel of purchasers, and conduct dynamic management based on the changes of the contents examined and verified;
4. be responsible for collecting and managing quality information, and establish drug quality archives;
5. be responsible for the acceptance of drugs, guide and supervise the quality management in such links as drug purchase, storage, maintenance, sales, rejection and transportation;
6. be responsible for the confirmation of nonconforming drugs, and supervise the treatment process of nonconforming drugs;
7. be responsible for the investigation in, handling of and reporting on drug quality complaints and quality accidents;
8. be responsible for the reporting on counterfeit and low-quality drugs;
9. be responsible for handling drug quality inquiry;
10. be responsible for guiding the setting of quality control functions of computer systems;
11. be responsible for examining and verifying the operating authorization for computer systems and establishing and updating basic data on quality management;
12. organize the verification and calibration of related facilities and equipment;
13. be responsible for the management of drug recall;
14. be responsible for the reporting on adverse reactions to drugs;
15. organize the internal audit and risk assessment on the quality management system;
16. organize the investigation and evaluation on the quality management systems and service quality of drug suppliers and purchasers;
17. organize the examination on transport conditions and quality assurance capability of the carrier that is entrusted with the transportation;
18. assist in carrying out quality management education and training; and
19. other duties to be performed by the quality management department.
Section 3 Personnel and Training
Article 18 The personnel of an enterprise engaging in drug operation and quality management shall meet the qualification requirements prescribed by the relevant laws and regulations as well as the Practice, and shall not conduct any practice prohibited by relevant laws and regulations.
Article 19 The person in charge of an enterprise shall have an educational degree of junior college or above or the professional and technical title above the medium-level, have received basic training on professional knowledge on the pharmaceutical field, and be familiar with the laws and regulations on drug management and the Practice.
Article 20 The person responsible for the quality in an enterprise shall have an educational degree above regular college, the qualification of licensed pharmacist, more than three-year working experience in drug operation and quality management, and the ability to make correct judgments and ensure the implementation in quality management work.
Article 21 The person responsible for the quality management department of an enterprise shall have the qualification of licensed pharmacist and more than three-year working experience in drug operation and quality management and be able to independently solve quality problems in the course of operation.
Article 22 An enterprise shall be staffed with quality management, acceptance and maintenance personnel meeting the following qualification requirements:
1. the personnel engaging in quality management shall have a degree of technical secondary school in pharmacy or a college degree or above in medicine, biology, chemistry or other related specialties or professional technical title above primary level in pharmacy;
2. the personnel engaging in acceptance and maintenance shall have a degree of technical secondary school or above in pharmacy or medicine, biology, chemistry or other related specialties or professional technical title above primary level in pharmacy; and
3. the personnel engaging in acceptance of traditional Chinese medicinal materials and Chinese herbal medicine shall have a degree of technical secondary school or above in science of Chinese pharmacology or professional technical title above intermediate level in science of Chinese pharmacology; the personnel engaging in the maintenance of traditional Chinese medicinal materials and Chinese herbal medicine shall have a degree of technical secondary school or above in science of Chinese pharmacology or professional technical title above primary level in science of Chinese pharmacology; the acceptance personnel directly purchasing traditional Chinese medicinal materials from producing areas shall have the professional technical title above intermediate level in science of Chinese pharmacology.
Enterprises dealing with vaccines shall also allocate two or more professional technical personnel responsible for vaccine quality management and acceptance; the professional technical personnel shall have a bachelor's degree or above in preventive medicine, pharmacy, microbiology or medicine and professional technical title above intermediate level, and more than three-year experience in vaccine management or technical work.
Article 23 The personnel engaging in quality management and acceptance shall be on job and on duty and shall not concurrently carry out other business work.
Article 24 The personnel engaging in procurement shall have a degree of technical secondary school or above in pharmacy or medicine, biology, chemistry or other related specialties; and those engaging in sales, storage and other work shall have the educational background of senior high school or above.
Article 25 An enterprise shall conduct pre-job training and continued training for all personnel on posts with respect to their duties and work contents, so as to conform to the requirements herein.
Article 26 The training contents shall include the relevant laws and regulations, drug professional knowledge and skills, quality management systems, duties and operating procedures for posts.
Article 27 An enterprise shall, based on the training management system, make its annual training plan and conduct the training, in a bid to enable relevant personnel to correctly understand and perform their duties. For the training, good records shall be made and files shall be established.
Article 28 The personnel engaging in storage, transportation and other work related to drugs under special management and refrigerated and frozen drugs shall accept the training regarding relevant laws and regulations and professional knowledge and shall not take the post unless passing the examination.
Article 29 An enterprise shall formulate the personal hygiene management system for its staff, and the dressing of the personnel on posts dealing with storage, transportation and other work shall meet the requirements on personal protection and product protection.
Article 30 The personnel on posts directly contacting drugs such as those of quality management, acceptance, maintenance, and storage shall receive pre-job and annual health examination and health records shall be established for them. Any person suffering from infectious disease or other diseases that may contaminate drugs may not engage in the work in which he could directly contact drugs. Any person whose physical conditions do not meet the specific requirements of the corresponding post shall not engage in the relevant work.
Section 4 Quality Management System Documents
Article 31 An enterprise shall prepare quality management system documents according to its actual conditions. The documents include quality management systems, duties of departments and posts, operating procedures, files, reports, records and vouchers.
Article 32 The drafting, revision, review, approval, distribution, custody, modification, cancellation, substitution and destruction of the documents shall be carried out in accordance with the operating procedures for document management, and the related records thereon shall be kept.
Article 33 The documents shall clearly indicate the title, category, purpose, document number and version number. The text thereof shall be accurate, clear, and easy to understand.
The documents shall be stored by category for the convenience of review.
Article 34 An enterprise shall regularly review and revise the documents; the documents used shall be currently effective text, and those that have been abolished or have become invalid shall, except for being kept for future reference, may not appear at the work site.
Article 35 An enterprise shall guarantee that the necessary documents corresponding to the work contents are available for each post, and the work shall be carried out in strict accordance with the provisions.
Article 36 The quality management system shall cover the following contents:
1. provisions on the internal audit of the quality management system;
2. provisions on the quality veto;
3. the administration of quality management documents;
4. the administration of quality information;
5. provisions on the qualification review of suppliers, purchasers, sales personnel of suppliers and purchase personnel of purchase entity;
6. the administration of drug purchase, receiving, acceptance, storage, maintenance, sales, delivery from storage and transportation;
7. provisions on drugs under special management;
8. the administration of the validity period of drugs;
9. the administration of nonconforming drugs and drug destruction;
10. the administration of drug rejection;
11. the administration of drug recall;
12. the administration of quality inquiry;
13. the administration of quality accidents and quality complaints;
14. provisions on the reporting on adverse reactions to drugs;
15. provisions on environmental sanitation and health of personnel;
16. provisions on the education, training and assessment in terms of quality;
17. the administration of custody and maintenance of facilities and equipment;
18. the administration of verification and calibration of facilities and equipment;
19.
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