Chapter III Quality Management of Drug Retail

Section 1 Quality Management and Responsibilities

Article 120 Enterprises shall, in accordance with relevant laws and regulations and the requirements of the GSP, formulate quality management documents and carry out quality management activities to ensure the quality of drugs.

Article 121 Enterprises shall have distribution conditions commensurate with their business scope and scale, including organizational structure, personnel, facilities and equipment and quality management documents, and set up a computer system in accordance with relevant provisions.

Article 122 The responsible person of an enterprise is the principal person in charge of drug quality, takes 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 distributes drugs according to the requirements in this GSP.

Article 123 The quality management department or quality management personnel of enterprises 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 documents, and guiding and supervising the implementation thereof;

(III) Being responsible for the audit of the qualification certificates of suppliers and their sales personnel;

(IV) Being responsible for the audit of legality of the drugs purchased;

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

(VI) Inquiring drug quality and quality information management;

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

(VIII) Validating unqualified drugs and handling thereof;

(IX) Reporting of substandard or falsified drugs;

(X) Reporting of ADRs;

(XI) Carrying out drug quality management education and training;

(XII) Being responsible for the audit and control of operation permission of computer system, and the maintenance of basic data of quality management;

(XIII) Organizing the calibration and validation of measuring instruments;

(XIV) Guiding and supervising pharmaceutical services;

(XV) Other responsibilities that shall be fulfilled by the quality management department or quality management personnel.

Section 2 Personnel Management

Article 124 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 125 The legal representative or the responsible person of an enterprise shall be qualified as a licensed pharmacist.

Enterprises shall, in accordance with the relevant national provisions, be equipped with licensed pharmacists to be responsible for the audit of prescriptions and guide rational use of drugs.

Article 126 Personnel engaged in quality management, acceptance inspection and purchase shall have academic qualifications in pharmacy or medicine, biology, chemistry or other related disciplines or have professional and technical titles in pharmacy. Personnel engaged in the quality management, acceptance inspection and purchase of Prepared Slices shall have a degree of technical school or above, or a primary professional and technical title or above in traditional Chinese medicine.

Sales personnel shall have a high school education or above, or meet the requirements stipulated by provincial food and drug regulatory department. The dispenser of Prepared Slices shall have a degree of technical school or above, or have the qualification certificate of the dispenser of traditional Chinese medicine.

Article 127 Personnel at all posts of enterprises shall have received pre-post training and on-the-job training on relevant laws and regulations as well as professional knowledge and skills of drugs to meet the requirements of the GSP.

Article 128 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 129 Enterprises shall provide conditions for the personnel selling drugs under special management, drugs with special management requirements by the State, or refrigerated drugs to receive corresponding training, so that they can master relevant laws, regulations and professional knowledge.

Article 130 In the business premises, personnel of enterprises shall wear neat and hygienic working clothes.

Article 131 Enterprises shall request pre-post and annual health examinations for personnel at the posts in direct contact with drugs, 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.

Article 132 Items and personal belongings irrelevant to drug distribution activities shall not be stored in the storage and display areas of drugs. There shall be no action in the working areas that may affect the quality and safety of drugs.

Section 3 Documentation

Article 133 Enterprises shall formulate quality management documents in line with their actual situation in accordance with the relevant laws and regulations and the provisions of the GSP. Documents include quality management system, post responsibilities, operating procedures, archives, records and vouchers, etc. Quality management documents shall be regularly reviewed and revised in time.

Article 134 Enterprises shall take measures to ensure that the personnel at all the posts can correctly understand the quality management documents to ensure their effective implementation.

Article 135 The quality management system for drug retail shall include the following contents:

(I) The management of the purchase, acceptance inspection, display and sales of drugs, and the management of storage and maintenance if a warehouse has been established;

(II) Audit of suppliers and varieties to be purchased;

(III) Management of the sales of prescription drugs;

(IV) Management of drugs dismantling;

(V) Management of drugs under special management and drugs with special management requirements by the State;

(VI) Management of records and vouchers;

(VII) Management of the collection and inquiry of quality information;

(VIII) Management of quality incidents and quality complaints;

(IX) Management of prescription audit, dispensing and checking of Prepared Slices;

(X) Management of the expiry date of drugs;

(XI) Management of unqualified drugs and drug destruction;

(XII) Provisions for environmental health and personnel health;

(XIII) Management of pharmaceutical services such as providing consultation on drug use and guiding rational use of drugs;

(XIV) Provisions on personnel training and assessment;

(XV) Provisions for reporting of ADRs;

(XVI) Computer system management;

(XVII) Provisions for the traceability of drugs;

(XVIII) Other contents that need to be specified.

Article 136 Enterprises shall specify the responsibilities of the responsible person of an enterprise, quality management, purchase, acceptance inspection, sales personnel, prescription audit and dispensing, and other posts, and also the responsibilities of storage, maintenance and other posts if a warehouse has been established.

Article 137 The responsibilities of the quality management post and the prescription audit post shall not be assumed by the personnel at other posts.

Article 138 The operating procedure for drug retail shall include:

(I) Drug purchase, acceptance inspection and sales;

(II) Prescription audit, dispensing and checking;

(III) Prescription audit, dispensing and checking for Prepared Slices;

(IV) Dismantling sales of drugs;

(V) The sales of drugs under special management and drugs with special management requirements by the State;

(VI) Drug display and inspection in business premises;

(VII) Storage of refrigerated drugs in business premises;

(VIII) Operation and management of computer system;

(IX) Operating procedure for storage and maintenance, if a warehouse has been established.

Article 139 Enterprises shall establish records related to drug purchase, acceptance inspection, sales, display and inspection, temperature and humidity monitoring, and disposal of unqualified drugs and make them authentic, complete, accurate, effective and traceable.

Article 140 Records and relevant vouchers shall be kept for at least 5 years. Records and vouchers of drugs under special management shall be kept in accordance with relevant regulations.

Article 141 In case of recording data through the computer system, personnel at relevant posts shall, in accordance with the operating procedure, log into the computer system with authorization and password to enter the data, so as to ensure that the data are original, authentic, accurate, safe and traceable.

Article 142 Electronic record data shall be backed up regularly in a safe and reliable manner.

Section 4 Facilities and Equipment

Article 143 Business premises of enterprises shall be in line with their business scope and scale, and be separated from the areas for drug storage, offices, living and other areas.

Article 144 Business premises shall be equipped with appropriate facilities or other effective measures shall be taken to prevent drugs from being affected by the outdoor environment, and the premises shall also be spacious, bright, clean and hygienic.

Article 145 Business premises shall have the following business equipment:

(I) Display racks and counters;

(II) Temperature monitoring and control equipment;

(III) Those distributing Prepared Slices shall have equipment for storing such drugs and prescription dispensing;

(IV) Those distributing refrigerated drugs shall have special refrigeration equipment;

(V) Those distributing Class II psychotropic drugs, toxic varieties of traditional Chinese medicines and pericarpium papaveris shall have special storage facilities that meet the safety provisions;

(VI) Dispensing tools and packaging supplies required for dismantling sales of drugs.

Article 146 Enterprises shall establish a computer system meeting the requirements for distribution and quality management, achieving the traceability of drugs.

Article 147 Where an enterprise establishes a warehouse, it shall ensure that the inner walls and ceiling of the warehouse are smooth and clean, the floor is flat and the doors and windows have a tight structure; and there are reliable safety protection, anti-theft and other measures.

Article 148 A warehouse shall have the following facilities and equipment:

(I) The equipment for effective separation between drugs and the ground;

(II) The equipment for preventing light, moisture, insects and rats, as well as for ventilation;

(III) The equipment for effective temperature monitoring and control;

(IV) The lighting equipment complying with the requirements for storage;

(V) Special place for acceptance inspection;

(VI) Special storage places for unqualified drugs;

(VII) Those distributing refrigerated drugs shall have special equipment appropriate to the varieties distributed and business scale.

Article 149 There shall be storage facilities that meet the provisions of the State for the distribution of drugs under special management.

Article 150 Special warehouses shall be established for the storage of Prepared Slices.

Article 151 Enterprises shall periodically carry out calibration or validation on measuring instruments and temperature and humidity monitoring equipment in accordance with relevant national provisions.

Section 5 Purchase and Acceptance Inspection

Article 152 Purchase of drugs by enterprises shall comply with the relevant provisions of Section 8 of Chapter II herein.

Article 153 Upon arrival of drugs, the receiving personnel shall, in accordance with the purchase records, check the material objects according to the accompanying sheet (bill) provided by suppliers and ensure that the bills, account and goods are consistent.

Article 154 Enterprises shall conduct acceptance inspection on the drugs arrived lot by lot in accordance with the prescribed procedures and requirements, and make acceptance inspection records in accordance with Article 80 herein.

Samples taken for acceptance inspection shall be representative.

Article 155 Upon arrival of refrigerated drugs, they shall be inspected in accordance with Article 74 herein.

Article 156 For acceptance inspection of drugs, drug inspection report shall be checked in accordance with Article 76 herein.

Article 157 Acceptance inspection shall be conducted for drugs under special management in accordance with relevant regulations.

Article 158 Drugs that are qualified in the acceptance inspection shall be warehoused or put on the shelf without delay; those failed the acceptance inspection shall not be warehoused or put on the shelf and shall be instead reported to the quality management personnel for handling.

Section 6 Display and Storage

Article 159 Enterprises shall monitor and control the temperature in their business premises so as to ensure that the temperature in the business premises meets normal temperature requirements.

Article 160 Enterprises shall carry out regular sanitary inspection and keep the environment clean and tidy. The equipment used for the storage or display of drugs shall be kept clean and sanitary, and shall not be placed with any item unrelated to the sales activities. Insect-proof and rat-proof measures shall be taken to prevent the contamination to drugs.

Article 161 The display of products shall meet the following requirements:

(I) Adopting classified display according to the dosage form, indications and storage requirements, and setting up clear marks with legible labels and accurate placement;

(II) The drugs shall be placed on shelves (cabinets) in an orderly manner and protected from direct sunlight;

(III) Prescription drugs and non-prescription drugs shall be displayed in different partitions, and bear special marks for them;

(IV) Open-shelf sales and self-selection mode is not allowed for prescription drugs;

(V) Drugs for topical use and other drugs shall be placed separately;

(VI) Drugs for dismantling sales shall be stored in a centralized manner in the dismantling counter or special partition;

(VII) Class II psychotropic drugs, toxic varieties of traditional Chinese medicines and pericarpium papaveris shall not be displayed;

(VIII) Refrigerated drugs shall be put into the refrigeration equipment, the temperature shall be monitored and recorded as specified, and the storage temperature shall be guaranteed to meet the requirements;

(IX) The drawer position of Prepared Slices shall be written with correct name and in regular script; before the loading of Prepared Slices, double check shall be conducted to prevent wrong or confused loading; the drawers shall be cleaned regularly to prevent Prepared Slices from insects, mildew and deterioration; and the drawers shall be cleared before the Prepared Slices of different lots are loaded, which shall be documented;

(X) A special partition shall be set up for distributing non-drugs, which shall be clearly separated from the drug partition and provided with clear marks.

Article 162 Enterprises shall regularly inspect the drugs on display or in storage, with the focus on dismantled drugs, perishable drugs, drugs approaching the expiry date, drugs that have been displayed for a long time and Prepared Slices. Any drugs identified with suspected quality issues shall be promptly withdrawn, the sales shall be discontinued, and quality management personnel shall confirm and take corresponding measures, and also keep the relevant records.

Article 163 Enterprises shall conduct tracking management for the expiry date of drugs so as to prevent possible post-expiration use of drugs approaching expiry date after they have been sold.

Article 164 Where an enterprise establishes a warehouse, the drug storage and maintenance management in the warehouse shall comply with Section 10 of Chapter II herein.

Section 7 Sales Management

Article 165 Enterprises shall hang its Drug Distribution Certificate, Business License, and Registration Certificate of Licensed Pharmacist at a prominent place in their business premises.

Article 166 Sales personnel shall wear work plates with photos, names, and posts. If they are licensed pharmacists and pharmaceutical technicians, the work plates shall also indicate their practicing qualifications or professional and technical titles. On-duty licensed pharmacists shall be listed and clearly stated.

Article 167 The sales of drugs shall meet the following requirements:

(I) Prescription can be dispensed only after being audited by licensed pharmacists. The drugs listed in the prescription shall not be altered or substituted without authorization. The dispensing of prescriptions with incompatibility or overdose shall be refused; however, those may be dispensed after being corrected or re-signed by the prescriber. After the dispensing of prescription, the drugs can be sold only after being checked;

(II) The prescription audit, dispensing and checking personnel shall sign or stamp on the prescriptions and keep the prescriptions or their copies in accordance with the relevant provisions;

(III) For the sales of drugs approaching expiry date, customers shall be informed of its expiry date;

(IV) For the sales of Prepared Slices, they shall be accurately weighed, and the customers shall be informed of the decocting and administration methods and corresponding precautions. The provision of decoction services for Prepared Slices shall conform to the relevant national provisions.

Article 168 Enterprises shall issue the proof of sales for drugs, including drug name, manufacturer, quantity, price, lot number and strength, and make the sales records.

Article 169 Dispensing sales of drugs shall meet the following requirements:

(I) The personnel responsible for dismantling sales shall have been specially trained;

(II) The workbench and tools for dismantling shall be kept clean and sanitary to prevent cross-contamination;

(III) The records of dismantling sales shall be made, including the starting date of dismantling, adopted name, strength, lot number, manufacturer, and expiry date of drugs, sales quantity, sales date, dismantling and checking personnel, etc.;

(IV) For dismantling sales, clean and sanitary package shall be used, on which the name, strength, quantity, usage, dosage, lot number, and expiry date of the drug, and name of the drug store shall be indicated;

(V) Providing the original or duplicated copy of the package insert of drugs;

(VI) During the period of dismantling sales, the original package and package insert shall be retained.

Article 170 The sales of drugs under special management and those with special management requirements of the State shall be carried out in strict accordance with the relevant national provisions.

Article 171 Drug advertising shall be conducted in strict accordance with the relevant national regulations on advertising management.

Article 172 Personnel who are not in-service staff of the enterprise shall not engage in activities related to drug sales in the business premises.

Section 8 After-sales Management

Article 173 No drug may be returned or exchanged once sold, except for quality reasons.

Article 174 Enterprises shall publish the supervisory telephone number of food and drug regulatory department in their business premises, set up customer's book, and in a timely manner handle customer complaints of drug quality.

Article 175 Enterprises shall collect and report the information of ADRs in accordance with national provisions on ADR reporting system.

Article 176 In case of identifying that a sold drug has serious quality issue, an enterprise shall immediately take measures to retrieve the drug, make records and report to the food and drug regulatory department.

Article 177 Enterprises shall assist drug manufacturers in implementing the recall obligation, control and withdraw drugs with safety hazards, and establish drug recall records.

Chapter IV Supplementary Provisions

Article 178 The terms in this GSP are defined as follows:

(I) In-service: registered personnel who have established labor relation with the enterprise;

(II) On-duty: personnel of the relevant posts performing their duties in the prescribed post during the working hours;

(III) First commercial enterprise: the drug manufacturer or distributor that has the supply and demand relation with the enterprise in the purchase of drugs;

(IV) First commercial varieties: drugs purchased by the enterprise for the first time;

(V) Original seal: the original seal of the enterprise, special seal for invoice, special seal for quality management, and special seal for drug ex-warehousing stamped on the relevant documents or vouchers to identify the enterprise in the purchase and sales activities, rather than a printed, photocopied, duplicated and other copies;

(VI) In quarantine: status of the arrived or returned drugs waiting for quality acceptance before being warehoused after effective means is adopted to isolate or distinguish them;

(VII) Break-bulk drugs: drugs with their packaging for transportation and storage removed;

(VIII) LCL shipping: the method of packing break-bulk drugs into the same packaging box for shipping;

(IX) Dismantling sales: the method of dismantling drugs into the minimum package for sales;

(X) Drugs with special management requirements by the State: drugs for which the State has adopted special regulatory measures, such as anabolic agents, peptide hormones, fixed dose combination containing special drugs, etc.

Article 179 The management of the headquarters of drug retail chain enterprise shall comply with the relevant provisions of the GSP for drug wholesale enterprises, and the management of its stores shall comply with the relevant provisions of the GSP for drug retail enterprises.

Article 180 The GSP provides basic requirements for quality management of drug distribution. Specific requirements for enterprise informatization management, automatic monitoring of temperature and humidity for drug storage and transportation, drug acceptance inspection management, drug cold chain logistics management, and retail chain management shall be separately formulated by the National Medical Products Administration (NMPA) in the form of appendixes.

Article 181 The traceability of narcotic and psychotropic drugs and pharmaceutical precursor chemicals shall conform to the relevant national provisions.

Article 182 The good practice for the purchase, storage and maintenance of drugs of pharmacies in medical institutions and family planning technical service institutions shall be formulated separately by the NMPA through consultation with relevant competent departments.

Provisions on the quality management of drugs sold on the Internet shall be formulated separately by the NMPA.

Article 183 In case a drug distributor violates this GSP, the food and drug regulatory departments shall give it a punishment in light of the provisions of Article 78 of the Drug Administration Law of the People's Republic of China.

Article 184 The GSP shall come into force on the date of promulgation, and the Good Supply Practice for Pharmaceutical Products (MOH Decree No.90) implemented by the Ministry of Health on June 1, 2013 shall be repealed at the same time.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.