Good Supply Practice for Pharmaceutical Products (2016Amendment)

Good Supply Practice for Pharmaceutical Products (2016Amendment) Good Supply Practice for Pharmaceutical Products (Issued by the Order No. 20 of the China Food and Drug Administration on April 30, 2000, amended for the first time adopted at the executive meeting of the former Ministry of Health on November 6, 2012, amended for the second time adopted at the executive meeting of the China Food and Drug Administration on May 18, 2015, and amended in accordance with the Decision of the China Food and Drug Administration on Amending the Good Supply Practice for Pharmaceutical Products and adopted at the executive meeting of the China Food and Drug Administration by the Order No. 28 of the China Food and Drug Administration on June 30, 2016) Chapter I General Provisions Article 1 For purposes of strengthening the quality management of drug distribution, regulating drug distribution, and ensuring the safety and effectiveness of drugs for human beings, this Practice is developed in accordance with the Drug Administration Law of the People's Republic of China , and the Regulation for the Implementation of the Drug Administration Law of the People's Republic of China . Article 2 This Practice is a set of basic rules for drug distribution management and quality control. Enterprises shall take effective quality control measures in drug purchase, storage, sale, transportation and other links, so as to ensure the quality of drugs, and establish the drug traceability system in accordance with the relevant requirements of the state, so as to achieve the traceability of drugs. Article 3 The sale 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 the relevant requirements of this Practice. Article 4 Drug distributors shall keep good faith and operate in accordance with law. Any and all false or deceptive behaviors shall be prohibited. Chapter II Quality Management of Drug Wholesale Section 1 Quality Management System Article 5 An enterprise shall, in accordance with the relevant laws and regulations and the requirements of this Practice, establish a quality management system, determine quality guidelines, draw up quality management system documents, and carry out quality planning, quality control, quality assurance, quality improvements, quality risk management and other activities. Article 6 The documents of quality guidelines of an enterprise shall specify the overall quality objectives and requirements of the enterprise, and be implemented throughout the whole process of drug distribution. 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, quality management system documents, and corresponding computer systems, among others. Article 8 An enterprise shall carry out internal audits on a regular basis or when any significant change occurs in the key elements of the quality management system. Article 9 An enterprise shall analyze the internal audits, and develop corresponding improvement measures for the quality management system on the basis of the analysis conclusions so as to constantly improve the quality control level and ensure the continuous and effective operation of the quality management system. Article 10 An enterprise shall, through a forward-looking or retrospective manner, assess, control, communicate and examine the quality risks in the drug circulation process. Article 11 An enterprise shall assess the quality management systems of drug suppliers and purchasers, verify their quality assurance capacity and quality reputation, and conduct on-site surveys when necessary. Article 12 All employees of an enterprise shall participate in quality management. The staff members of all departments and posts shall correctly understand and perform their duties and bear corresponding responsibilities for quality. Section 2 Organizational Structure and Quality Management Duties Article 13 An enterprise shall set up organizational structure or positions commensurate with its business activities and quality management, and clearly specify their duties, authorities and mutual relationships. Article 14 The person in charge of an enterprise shall be the primary person to take charge of drug quality, bear overall responsibility for the daily management of the enterprise, and be responsible for providing necessary conditions to ensure the effective performance of duties by the quality management department and quality management personnel, and ensure the enterprise's realization of the quality objectives and distribution of drugs pursuant to the requirements of this Practice. Article 15 The position of person-in-charge of quality of an enterprise shall be held by a senior manager, who shall bear overall responsibility for the management of drug quality, independently perform his or her duties, and have the right of judgment over drug quality management inside the enterprise. Article 16 An enterprise shall set up a quality management department so as to effectively carry out quality management. The duties of the quality management department shall not be performed by any other department or personnel. Article 17 A quality management department shall perform the following duties: (1) urging the relevant departments and personnel to implement the laws and regulations on drug administration and this Practice; (2) organizing the development of quality management system documents, and guiding and supervising the implementation thereof; (3) being responsible for examining the legality of the suppliers and purchasers, the legality of the purchased drugs, and the legal qualifications of the salespersons of the suppliers and the purchasing staff of the purchasers, and conducting dynamic management on the basis of the changes in the examination contents; (4) being responsible for the collection and management of quality information, and setting up drug quality archives; (5) being responsible for the acceptance check of drugs, and guiding and supervising the quality management in drug purchase, storage, maintenance, sale, return, and transportation, among others; (6) being responsible for the determination of unqualified drugs and supervising the disposal process of unqualified drugs; (7) being responsible for the investigation, handling and reporting of drug quality complaints and quality incidents; (8) being responsible for the reporting of shoddy drugs and drugs of inferior quality; (9) being responsible for responding to the inquiries about drug quality; (10) being responsible for guiding the setting of quality control function of the computer system; (11) being responsible for the examination and approval of the operating authority of the computer system and the establishment and update of the basic quality management data; (12) organizing the validation and calibration of relevant facilities and equipment; (13) being responsible for the management of drug recalls; (14) being responsible for the reporting of adverse drug reactions; (15) organizing the internal audit and risk assessment of the quality management system; (16) organizing the surveys and assessment of the quality management systems and service quality of the drug suppliers and purchasers; (17) organizing the examination of the transportation conditions and quality assurance capacity of the carriers who are entrusted with transportation; (18) assisting in conducting quality management education and training; and (19) other duties that should be performed by the quality management department. Section 3 Personnel and Training Article 18 The drug distribution and quality management personnel of an enterprise shall comply with the qualification requirements of the relevant laws and regulations and this Practice, and may not fall under any of the circumstances prohibited from practice. Article 19 The person-in-charge of an enterprise shall have an educational background of junior college or above or an intermediate professional title or above, have received training on basic pharmacy knowledge, and be familiar with the relevant laws and regulations on drug administration and this Practice. Article 20 The person in charge of quality affairs of an enterprise shall have a university diploma at or above the undergraduate level, the qualification of licensed pharmacist, and have engaged in drug distribution quality management for three years or more, and have the ability to make correct judgments and practical capacity in the work of quality management. Article 21 The person in charge of the quality management department of an enterprise shall have the qualification of licensed pharmacist, and have engaged in drug distribution quality management for three years or more, and is able to independently solve the quality problems in the distribution process. Article 22 An enterprise shall be staffed with people working at the positions of quality management, acceptance check, and maintenance, among others, and meeting the following qualification requirements: (1) The personnel engaged in quality management shall have the educational background of a technical secondary school or above in pharmacy, or a junior college or above of relevant specialties such as medical science, biology, and chemistry, or a junior professional title or above in pharmacy; (2) The personnel engaged in acceptance check or maintenance shall have the educational background of a technical secondary school or above in pharmacy or of relevant specialties such as medical science, biology, and chemistry, or a junior professional title or above in pharmacy; and (3) The personnel engaged in the acceptance check of Chinese crude drugs and prepared slices of Chinese crude drugs shall have the educational background of a technical secondary school or above in traditional Chinese medicine, or an intermediate professional title or above in traditional Chinese medicine; and the personnel engaged in the maintenance of Chinese crude drugs and prepared slices of Chinese crude drugs shall have the educational background of a technical secondary school or above in traditional Chinese medicine or a junior professional title or above in traditional Chinese medicine; and for an enterprise engaged in direct purchase of Chinese crude drugs derived from medical herbs, the personnel for acceptance checks shall have an intermediate professional title or above in traditional Chinese medicine. An enterprise engaging in vaccine distribution shall also be staffed with two or more professional and technical persons to specially take charge of vaccine quality management and acceptance check. Professional and technical persons shall have a university diploma at or above the undergraduate level of the specialties such as preventive medicine, pharmacy, microbiology or medicine and an intermediate professional title or above, and have engaged in vaccine management or technical work for three years or more. Article 23 The personnel engaged in quality management and acceptance check shall be in service and be on duty, and may not take a part-time job of any other business. Article 24 The personnel engaged in purchases shall have the educational background of a technical secondary school or above in pharmacy or of relevant specialties such as medical science, biology, and chemistry, and the personnel engaged in sale or storage, etc. shall have the educational background of a senior high school or above. Article 25 An enterprise shall provide the staff of all positions with pre-job training and continuing training relevant to their duties and job contents, so as to meet the requirements of this Practice. Article 26 The contents of trainings shall include the relevant laws and regulations, pharmaceutical professional knowledge and skills, quality management rules, duties, and position-related operational rules, among others. Article 27 An enterprise shall, in accordance with the training management rules, prepare an annual training plan and carry out trainings to help the relevant personnel correctly understand and perform their duties. The enterprise shall properly keep records of the trainings and set up archives. Article 28 The personnel engaged in the storage, transportation, and so on, of the drugs under special management and drugs need to be refrigerated or frozen shall receive trainings on relevant laws and regulations as well as professional knowledge and shall pass examination before taking their positions. Article 29 An enterprise shall develop rules for personal hygiene management of employees, and the attire of the personnel at the positions of storage, and transportation, among others, shall meet the requirements of labor protection and product protection. Article 30 The personnel at the positions in direct contact with drugs, such as quality management, acceptance check, maintenance, and storage shall be subject to pre-job and annual health examination, and health records shall be kept for them. No one who suffers from any infectious disease or any other disease that may cause contamination to drugs may engage in the work in direct contact with drugs. No person whose physical conditions do not meet the specific requirements of corresponding positions may engage in the relevant work. Section 4 Quality Management System Documents Article 31 The quality management system documents of an enterprise shall be in compliance with its actual conditions. The documents shall include quality management rules, duties of the departments and positions, operational rules, files, reports, records, and certificates, among others. Article 32 The draft, revision, review, approval, distribution, keeping, amendment, revocation, replacement, and destruction, among others, of documents shall be conducted in accordance with the document management operational rules, and relevant records shall be kept. Article 33 The documents shall indicate the titles, types, purposes, serial numbers, and version numbers. The documents shall be accurate, clear and easy to understand. The documents shall be stored by categories for easy access. Article 34 An enterprise shall review and revise the documents on a regular basis and the documents used shall be currently effective, and the documents which have been abolished or invalidated may not appear in the work site except for those archived for future reference. Article 35 An enterprise shall ensure that all positions have full access to the necessary documents corresponding to their work, and carry out work in strict accordance with the relevant provisions. Article 36 Quality management rules shall include: (1) provisions on the internal audit of the quality management system; (2) provisions on quality veto; (3) the management of quality management documents; (4) the management of quality information; (5) provisions on the qualification examination of suppliers, purchasers, salespersons of suppliers, and purchasing staff of purchasers, among others; (6) the management of purchase, receipt, acceptance check, storage, maintenance, sale, delivery from warehouse and transportation of drugs; (7) provisions on the drugs under special management; (8) the management of date of expiry of drugs; (9) the management of unqualified drugs and destruction of drugs; (10) the management of return of drugs; (11) the management of drug recalls; (12) the management of quality inquires; (13) the management of quality incidents and quality complaints; (14) provisions on the reporting of adverse drug reactions; (15) provisions on environmental sanitation and personnel health; (16) provisions on education, training and assessment regarding quality; (17) the management of keeping and maintenance of facilities and equipment; (18) the management of validation and calibration of facilities and equipment; (19) the management of records and certificates; (20) the management of the computer system; (21) Provisions on drug traceability; and (22) other contents that should be provided for. Article 37 The duties of departments and positions shall include: (1) the duties of departments of quality management, purchase, storage, sale, transportation, finance, and information management, among others; (2) the post-related responsibilities of the person in charge of the enterprise, the person in charge of quality, and the persons in charge of the departments of quality management, purchase, storage, sale, transportation, finance, and information management, among others; (3) the duties of the posts of quality management, purchase, receipt of goods, acceptance check, storage, maintenance, sale, warehouse outbound reviews, transportation, finance, and information management, among others; and (4) the duties of other posts in connection with drug distribution. Article 38 An enterprise shall develop operational rules for the sectors of drug purchase, receipt, acceptance check, storage, maintenance, sale, warehouse outgoing reviews, and transportation, among others, and for computer systems. Article 39 An enterprise shall keep relevant records of drug purchase, acceptance check, maintenance, sale, warehouse outgoing reviews, sales return, purchase return, transportation, temperature and humidity monitoring during storage and transportation, and handling of unqualified drugs, among others, and ensure that such records are true, complete, accurate, effective and trackable. Article 40 When recording data through the computer system, the relevant personnel cannot input or review data unless they comply with the operational rules, obtain authorization and log on with a password; the modification of data shall be audited by the quality management department and be conducted under the supervision thereof, and records shall be kept for the modification process. Article 41 The written records and certificates shall be filled out in a timely manner, be legible, and shall neither be altered randomly nor be torn up. In the case of modification of the records, the relevant party shall indicate the reasons and date, affix their signatures to the records, and keep the original information sufficiently distinctive. Article 42 The records and certificates shall be kept for at least five years. The records and certificates of vaccines and drugs under special management shall be kept in accordance with the relevant provisions. Section 5 Facilities and Equipment Article 43 An enterprise shall have business premises and warehouses commensurate with the scope and scale of drug distribution. Article 44 The site selection, design, layout, construction, reconstruction and maintenance of warehouses shall meet the requirements for drug storage so as to prevent the contamination, cross-contamination, confusion and errors of drugs. Article 45 The storage operation area and auxiliary operation area of drugs shall be separated from the office area and living area with a certain distance or through isolation measures. Article 46 The size and conditions of a warehouse shall satisfy the requirements of reasonable and safe storage of drugs and meet the following requirements to facilitate storage operation: (1) The internal and external environments of the warehouse are clean, and have no pollution sources, and the ground of the warehouse area is hardened or planted with plants; (2) The interior walls and ceiling of the warehouse are smooth, the floor is flat, and the doors and windows solid in structure; (3) There are reliable security measures for the warehouse which are able to apply controllable management to the access of unrelated personnel so as to prevent the drugs from being stolen, replaced or mixed with counterfeit drugs; and (4) There are measures to prevent the outdoor loading and unloading, conveying, receipt, and delivery, among others, from being affected by abnormal weather. Article 47 A warehouse shall be equipped with the following facilities and equipment: (1) equipment for effective separation of drugs from the floor; (2) light protection, ventilation, moisture proof, insect prevention, and rat proof equipment; (3) the equipment for effective regulation and control of temperature and humidity and ventilation; (4) the equipment for automatic monitoring and record of the temperature and humidity of the warehouse; (5) the lighting equipment meeting the requirements of storage operations; (6) the operating areas and equipment for the sorting of the unpacked goods, groupage delivery operation and review; (7) the places for the storage of packaging materials; (8) special places for acceptance checks, delivery and return of goods; (9) special places for the storage of unqualified drugs; and (10) for the distribution of drugs under special management, storage facilities meeting the relevant provisions of the state. Article 48 An enterprise engaged in the distribution of Chinese crude drugs and prepared slices of Chinese crude drugs shall have a special warehouse and maintenance workplace, and an enterprise engaged in direct purchase of the Chinese crude drugs derived from medical herbs shall set up a showroom (cabinet) for traditional Chinese medicines. Article 49 An enterprise engaging in drugs that need to be stored, transported, refrigerated or frozen shall be equipped with the following facilities and equipment: (1) A refrigerator suitable for its business scale and varieties, and for an enterprise engaging in the storage of vaccines, two or more independent refrigerators. (2) The equipment used for the automatic monitoring, display, recording, control and alarm of the temperature of the refrigerator. (3) The standby generator sets or double circuit power supply systems for the refrigeration equipment of the refrigerator. (4) For the drugs with special low-temperature requirements, the facilities and equipment meeting the storage requirements thereof. (5) Refrigerated vehicles, on-vehicle refrigerated boxes or heat preservation boxes and other equipment. Article 50 The drugs shall be transported through closed cargo transport vehicles. Article 51 The refrigerated vehicles, on-vehicle refrigerated boxes or heat preservation boxes for the transportation of drugs that need to be refrigerated or frozen shall meet the requirements for temperature control during the transportation of drugs. Refrigerated vehicles shall have the functions of automatic control of temperature, display of temperature, memory and reading of the temperature monitoring data; and the refrigerated boxes or heat preservation boxes shall have the functions of external display and reading the temperature inside the boxes. Article 52 There shall be special persons to be responsible for the regular inspection, cleaning and maintenance of the storage and transportation facilities and equipment, and records and archives shall be set up. Section 6 Calibration and Validation Article 53 An enterprise shall, in accordance with the relevant provisions of the state, calibrate or verify the measuring instruments, and temperature and humidity monitoring equipment on a regular basis. An enterprise shall conduct validation on refrigerators, storage and transportation temperature and humidity monitoring systems, and facilities and equipment of refrigeration transp......