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Good Supply Practice for Pharmaceutical Products
Published:
2015-12-13
Good Manufacturing Practice for Pharmaceutical Operation (Ministry of Health Order No. 90)
National Health and Family Planning Commission of the People's Republic of China www.moh.gov.cn
No. 90
The "Good Manufacturing Practice for Pharmaceutical Operation" was reviewed and approved by the Ministry of Health on November 6, 2012, and is hereby promulgated, effective from June 1, 2013.
Minister Chen Zhu
January 22, 2013
Good Manufacturing Practice for Pharmaceutical Operation
Chapter 1 General Provisions
Article 1 To strengthen the quality management of pharmaceutical operation, regulate pharmaceutical business conduct, and ensure the safety and effectiveness of medications for human use, these regulations are formulated in accordance with the "Drug Administration Law of the People's Republic of China" and the "Implementation Regulations of the Drug Administration Law of the People's Republic of China."
Article 2 These regulations are the basic guidelines for pharmaceutical operation management and quality control. Enterprises shall take effective quality control measures in the processes of drug procurement, storage, sales, transportation, and other links to ensure drug quality.
Article 3 Pharmaceutical operation enterprises shall strictly implement these regulations.
Pharmaceutical manufacturing enterprises selling drugs and other parties involved in the storage and transportation of drugs during drug circulation shall also comply with the relevant requirements of these regulations.
Article 4 Pharmaceutical operation enterprises shall adhere to honesty and trustworthiness and operate according to law. Any false or deceptive behavior is prohibited.
Chapter 2 Quality Management of Drug Wholesale
Section 1 Quality Management System
Article 5 Enterprises shall establish a quality management system based on relevant laws, regulations, and the requirements of these regulations, determine 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 implement them throughout the entire pharmaceutical operation process.
Article 7 The enterprise quality management system shall be appropriate to its business scope and scale, 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 quality control levels, and ensure the continuous and effective operation of the quality management system.
Article 10 Enterprises shall adopt a prospective or retrospective approach to assess, control, communicate, and review quality risks in the drug circulation process.
Article 11 Enterprises shall evaluate the quality management systems of drug suppliers and purchasers, confirm their quality assurance capabilities and reputations, and conduct on-site inspections if necessary.
Article 12 Enterprises shall involve all employees in quality management. Departments and personnel 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 organizational structures or positions appropriate to their business activities and quality management, clearly defining their responsibilities, authorities, and interrelationships.
Article 14 The enterprise leader is the primary person responsible for drug quality, fully responsible for daily management, providing necessary conditions, ensuring that the quality management department and personnel effectively perform their duties, ensuring the enterprise achieves quality objectives and operates drugs according to these regulations.
Article 15 The enterprise quality leader shall be a senior management personnel, fully responsible for drug quality management, independently performing duties, and having decision-making authority over 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 drug management laws, regulations, and these regulations;
(2) Organize the formulation of quality management system documents and guide and supervise the implementation of these documents;
(3) Responsible for reviewing the legality of suppliers and purchasers, the legality of purchased drugs, and the legal qualifications of supplier sales personnel and purchaser procurement personnel, and dynamically manage according to changes in review content;
(4) Responsible for collecting and managing quality information and establishing drug quality archives;
(5) Responsible for drug acceptance, guiding and supervising quality management in drug procurement, storage, maintenance, sales, returns, transportation, and other links;
(6) Responsible for confirming nonconforming drugs and supervising the handling process of nonconforming drugs;
(7) Responsible for investigating, handling, and reporting drug quality complaints and quality incidents;
(8) Responsible for reporting counterfeit and inferior drugs;
(9) Responsible for drug quality inquiries;
(10) Responsible for guiding the setting of computer system quality control functions;
(11) Responsible for reviewing computer system operation permissions and establishing and updating quality management basic data;
(12) Organize verification and calibration of related facilities and equipment;
(13) Responsible for drug recall management;
(14) 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 reviews of 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 pharmaceutical operation and quality management shall meet the qualification requirements stipulated by relevant laws, regulations, and these regulations and shall not have circumstances prohibited by relevant laws and regulations.
Article 19 Enterprise leaders shall have a college diploma or above or an intermediate or higher professional technical title, have undergone basic pharmaceutical professional knowledge training, and be familiar with relevant drug management laws, regulations, and these regulations.
Article 20 The person in charge of enterprise quality shall have a university bachelor's degree or above, a licensed pharmacist qualification, and more than 3 years of experience in drug business quality management, possessing the ability to make correct judgments and ensure implementation in quality management work.
Article 21 The head of the enterprise quality management department shall have a licensed pharmacist qualification and more than 3 years of experience in drug business quality management, capable of independently solving quality issues during the business process.
Article 22 Enterprises shall be equipped with personnel in quality management, acceptance, and maintenance positions who meet the following qualification requirements:
(1) Those engaged in quality management work shall have a pharmacy technical secondary school diploma or a college degree or above in medicine, biology, chemistry, or related majors, or hold a junior or above professional technical title in pharmacy;
(2) Those engaged in acceptance and maintenance work shall have a pharmacy or medicine, biology, chemistry, or related major technical secondary school diploma or above, or hold a junior or above professional technical title in pharmacy;
(3) Those engaged in the acceptance of Chinese medicinal materials and Chinese herbal pieces shall have a technical secondary school diploma or above in Chinese medicine or hold an intermediate or above professional technical title in Chinese medicine; those engaged in the maintenance of Chinese medicinal materials and Chinese herbal pieces shall have a technical secondary school diploma or above in Chinese medicine or hold a junior or above professional technical title in Chinese medicine; for direct purchase of locally grown Chinese medicinal materials, acceptance personnel shall hold an intermediate or above professional technical title in Chinese medicine.
Enterprises operating vaccines shall also be equipped with at least two professional technical personnel specifically responsible for vaccine quality management and acceptance. These professionals shall have a bachelor's degree or above in preventive medicine, pharmacy, microbiology, or medicine, hold an intermediate or above 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 shall be on duty and shall not concurrently engage in other business work.
Article 24 Personnel engaged in procurement work shall have a technical secondary school diploma or above in pharmacy, medicine, biology, chemistry, or related majors; personnel engaged in sales, storage, and other work shall have a high school education or above.
Article 25 Enterprises shall provide pre-job training and continuing training related to the responsibilities and work content of each position to meet the requirements of this specification.
Article 26 Training content shall include relevant laws and regulations, professional knowledge and skills of pharmaceuticals, quality management systems, responsibilities, and job operation procedures.
Article 27 Enterprises shall formulate annual training plans and conduct training according to the training management system, enabling relevant personnel to correctly understand and perform their duties. Training work shall be properly recorded and archived.
Article 28 Personnel engaged in the storage and transportation of specially managed drugs and refrigerated and frozen drugs shall receive relevant legal and professional knowledge training and can only be on duty after passing the assessment.
Article 29 Enterprises shall establish employee personal hygiene management systems. The attire of personnel in storage, transportation, and other positions shall meet labor protection and product protection requirements.
Article 30 Personnel in quality management, acceptance, maintenance, storage, and other positions directly contacting drugs shall undergo pre-job and annual health checks and establish health records. Those suffering from infectious diseases or other diseases that may contaminate drugs shall not engage in work directly contacting drugs. Those whose physical conditions do not meet the specific requirements of the corresponding positions shall not engage in related work.
Section 4 Quality Management System Documents
Article 31 Enterprises shall formulate quality management system documents that conform to the actual situation of the enterprise. Documents include quality management systems, departmental and positional 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 shall be conducted according to document management operating procedures, and relevant records shall be kept.
Article 33 Documents shall indicate the title, type, purpose, document number, and version number. The text shall be accurate, clear, and easy to understand. Documents shall be classified and stored for easy reference.
Article 34 Enterprises shall regularly review and revise documents. The documents used shall be current and valid texts. Obsolete or invalid documents shall not appear at the work site except for archival reference.
Article 35 Enterprises shall ensure that each position obtains the necessary documents corresponding to their work content and strictly carry out work according to regulations.
Article 36 Quality management systems shall include the following content:
(1) Provisions for internal audits of the quality management system;
(2) Provisions for quality veto rights;
(3) Management of quality management documents;
(4) Management of quality information;
(5) Provisions for qualification audits of suppliers, purchasers, supplier sales personnel, and purchaser procurement personnel;
(6) Management of drug procurement, receipt, acceptance, storage, maintenance, sales, outbound, and transportation;
(7) Provisions for specially managed drugs;
(8) Management of drug expiration dates;
(9) Management of nonconforming drugs and drug destruction;
(10) Management of drug returns;
(11) Management of drug recalls;
(12) Management of quality inquiries;
(13) Management of quality incidents and quality complaints;
(14) Provisions for reporting adverse drug reactions;
(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 contents that should be stipulated.
Article 37 Departmental and positional responsibilities shall include:
(1) Responsibilities of departments such as quality management, procurement, storage, sales, transportation, finance, and information management;
(2) Job responsibilities of enterprise leaders, quality leaders, and heads of departments such as quality management, procurement, storage, sales, transportation, finance, and information management;
(3) Responsibilities for quality management, procurement, receipt, acceptance, storage, maintenance, sales, outbound review, transportation, finance, and information management positions;
(4) Other responsibilities related to pharmaceutical business operations.
Article 38: Enterprises shall formulate operating procedures for pharmaceutical procurement, receipt, acceptance, storage, maintenance, sales, outbound review, transportation, and computer systems.
Article 39: Enterprises shall establish relevant records for pharmaceutical procurement, acceptance, maintenance, sales, outbound review, post-sale returns and purchase withdrawals, transportation, storage and transportation temperature and humidity monitoring, and handling of nonconforming drugs, ensuring authenticity, completeness, accuracy, effectiveness, and traceability.
Article 40: When recording data through computer systems, relevant personnel shall enter or review data only after logging in with authorization and password according to operating procedures; data changes shall be reviewed by the quality management department and conducted under its supervision, with records kept of the change process.
Article 41: Written records and vouchers shall be filled out promptly, with clear handwriting, and shall not be arbitrarily altered or torn. If records are changed, the reason, date, and signature shall be indicated, keeping the original information clear and identifiable.
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 appropriate to their pharmaceutical business scope and scale.
Article 44: The location, design, layout, construction, renovation, and maintenance of warehouses shall meet pharmaceutical storage requirements to prevent contamination, cross-contamination, confusion, and errors of drugs.
Article 45: Pharmaceutical storage operation areas and auxiliary operation areas shall be separated by a certain distance or have isolation measures from office and living areas.
Article 46: The scale and conditions of warehouses shall meet the reasonable and safe storage of drugs and meet the following requirements to facilitate storage operations:
(1) The environment inside and outside the warehouse is clean, free of pollution sources, with hardened or greened ground in the storage area;
(2) The interior walls and ceiling of the warehouse are smooth, the floor is flat, and doors and windows are tightly constructed;
(3) The warehouse has reliable security measures to control access by unauthorized personnel, preventing theft, substitution, or mixing of counterfeit drugs;
(4) Measures are in place to prevent abnormal weather from affecting outdoor loading, unloading, handling, receiving, and dispatching operations.
Article 47: Warehouses shall be equipped with the following facilities and equipment:
(1) Equipment that effectively isolates drugs from the ground;
(2) Equipment for light protection, ventilation, moisture prevention, pest control, and rodent prevention;
(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) Operation areas and equipment for picking loose goods, consolidated shipments, and review;
(7) Storage places for packaging materials;
(8) Dedicated areas for acceptance, shipping, and returns;
(9) Dedicated storage areas for nonconforming drugs;
(10) Storage facilities that comply with national regulations for specially managed drugs.
Article 48: Enterprises dealing with Chinese medicinal materials and decoction pieces shall have dedicated warehouses and maintenance workspaces; those directly purchasing local Chinese medicinal materials shall set up Chinese medicine sample rooms (cabinets).
Article 49: Enterprises dealing with refrigerated and frozen drugs shall be equipped with the following facilities and equipment:
(1) Cold storage appropriate to their business scale and variety; enterprises dealing with vaccines shall have two or more independent cold storages;
(2) Equipment for automatic monitoring, display, recording, regulation, and alarm of cold storage temperature;
(3) Backup generator sets or dual-circuit power supply systems for cold storage refrigeration equipment;
(4) Facilities and equipment that meet storage requirements for drugs with special low-temperature needs;
(5) Refrigerated vehicles and vehicle-mounted refrigerated boxes or insulated boxes.
Article 50: Closed cargo transportation tools shall be used for transporting drugs.
Article 51: Refrigerated vehicles and vehicle-mounted refrigerated boxes or insulated boxes used for transporting refrigerated and frozen drugs shall meet temperature control requirements during transportation. Refrigerated vehicles shall have functions for automatic temperature regulation, temperature display, storage, and reading of temperature monitoring data; refrigerated boxes and insulated boxes shall have external display and internal temperature data collection functions.
Article 52: Regular inspection, cleaning, and maintenance of storage and transportation facilities and equipment shall be assigned to dedicated personnel, with records and archives established.
Section 6 Calibration and Validation
Article 53: Enterprises shall regularly calibrate or verify measuring instruments, temperature and humidity monitoring equipment, etc., according to national regulations.
Enterprises shall conduct pre-use validation, periodic validation, and validation after exceeding the prescribed downtime for cold storage, storage and transportation temperature and humidity monitoring systems, and refrigerated transportation facilities and equipment.
Article 54: Enterprises shall establish validation control documents according to relevant validation management systems, including validation plans, reports, evaluations, deviation handling, and preventive measures.
Article 55: Validation shall be carried out according to pre-determined and approved plans; validation reports shall be reviewed and approved, and validation documents shall be archived.
Article 56: Enterprises shall correctly and reasonably use relevant facilities and equipment based on parameters and conditions determined by validation.
Section 7 Computer Systems
Article 57: Enterprises shall establish computer systems that meet the requirements of full-process management and quality control, realize pharmaceutical quality traceability, and satisfy the implementation conditions of electronic drug supervision.
Article 58: Enterprise computer systems shall meet the following requirements:
(1) There are servers and terminals supporting the normal operation of the system;
(2) There is a safe and stable network environment, with a fixed way to access the Internet and a secure and reliable information platform;
(3) There is a local area network that enables information transmission and data sharing between departments and positions;
(4) There are functions for generating, printing, and managing business invoices for pharmaceutical operations;
(5) There are application software and related databases that meet the requirements of this specification and the actual needs of enterprise management.
Article 59: Operations such as data entry, modification, and saving of various data shall comply with the authorized scope, operating procedures, and management system requirements to ensure the data is original, authentic, accurate, secure, and traceable.
Article 60: Data related to enterprise operation and management involved in the computer system operation shall be stored in a safe and reliable manner and backed up daily. Backup data shall be kept in a secure location, and the retention period of record-type data shall comply with the requirements of Article 42 of this specification.
Section 8 Procurement
Article 61: The enterprise's procurement activities shall meet the following requirements:
(1) Confirm the legal qualifications of the supplier;
(2) Confirm the legality of the purchased drugs;
(3) Verify the legal qualifications of the supplier's sales personnel;
(4) Sign a quality assurance agreement with the supplier.
For first-time enterprises and first-time varieties involved in procurement, the procurement department shall fill out relevant application forms and obtain approval from the quality management department and the enterprise's quality responsible person. If necessary, on-site inspections should be organized to evaluate the supplier's quality management system.
Article 62: For the review of first-time enterprises, the following documents stamped with the supplier's official seal shall be checked to confirm authenticity and validity:
(1) Copies of the "Drug Manufacturing License" or "Drug Business License";
(2) Copies of the business license and its annual inspection certificate;
(3) Copies of the "Good Manufacturing Practice" certification or "Good Supply Practice" certification;
(4) Relevant seals and samples of accompanying delivery notes (invoices);
(5) Account name, bank, and account number;
(6) Copies of the "Tax Registration Certificate" and "Organization Code Certificate".
Article 63: When procuring first-time varieties, the legality of the drugs shall be reviewed, and copies of drug manufacturing or import approval documents stamped with the supplier's official seal shall be requested and reviewed. Procurement can only proceed if the review is correct.
The above materials shall be included in the drug quality files.
Article 64: The enterprise shall verify and retain the following information of the supplier's sales personnel:
(1) A copy of the sales personnel's ID card stamped with the supplier's official seal;
(2) An authorization letter stamped with the supplier's official seal and the legal representative's seal or signature. The authorization letter shall specify the authorized person's name, ID number, and the authorized varieties, regions, and duration of sales;
(3) Relevant information about the supplier and the supplied varieties.
Article 65: The quality assurance agreement signed between the enterprise and the supplier shall at least include the following content:
(1) Clarify the quality responsibilities of both parties;
(2) The supplier shall provide compliant materials and be responsible for their authenticity and validity;
(3) The supplier shall issue invoices according to national regulations;
(4) Drug quality shall meet drug standards and related requirements;
(5) Drug packaging, labels, and instructions shall comply with relevant regulations;
(6) Quality assurance and responsibility for drug transportation;
(7) The validity period of the quality assurance agreement.
Article 66: When purchasing drugs, the enterprise shall request invoices from the supplier. The invoice shall list the drug's generic name, specifications, unit, quantity, unit price, amount, etc.; if not all can be listed, a "List of Goods Sold or Taxable Services Provided" shall be attached, stamped with the supplier's special invoice seal and indicating the tax invoice number.
Article 67: The names of the purchasing and selling units, amounts, and product names on the invoice shall be consistent with the payment flow, amounts, and product names, and correspond to the financial account content. Invoices shall be kept according to relevant regulations.
Article 68: Procurement records shall be established for drug purchases. Procurement records shall include the drug's generic name, dosage form, specifications, manufacturer, supplier, quantity, price, purchase date, etc. For Chinese medicinal materials and decoction pieces, the place of origin shall also be indicated.
Article 69: In cases of disasters, epidemics, emergencies, clinical urgent treatment, or other situations meeting national regulations, enterprises may use direct allocation methods for drug purchase and sales, where purchased drugs are not stored in the enterprise's warehouse but sent directly from the supplier to the purchasing unit, with special procurement records established to ensure effective quality tracking and traceability.
Article 70: The procurement of specially managed drugs shall be strictly in accordance with national regulations.
Article 71: Enterprises shall regularly conduct comprehensive quality evaluations of overall drug procurement, establish drug quality evaluation and supplier quality files, and carry out dynamic tracking management.
Section 9 Receipt and Acceptance
Article 72: Enterprises shall receive and inspect incoming drugs batch by batch according to prescribed procedures and requirements to prevent unqualified drugs from entering the warehouse.
Article 73: Upon drug arrival, receiving personnel shall verify whether the transportation method meets requirements and check the drugs against accompanying delivery notes (invoices) and procurement records to ensure consistency among documents, accounts, and goods.
The accompanying delivery note (invoice) shall include the supplier, manufacturer, drug generic name, dosage form, specifications, batch number, quantity, receiving unit, receiving address, shipping date, etc., and be stamped with the supplier's special drug outbound seal.
Article 74: For refrigerated and frozen drugs upon arrival, key inspections and records shall be made on transportation methods, temperature records during transport, transportation time, and other quality control conditions. Drugs not meeting temperature requirements shall be rejected.
Article 75: Receiving personnel shall place medicines that meet the receiving requirements in the corresponding quarantine area according to the characteristics of the variety, or set status signs and notify acceptance. Refrigerated and frozen medicines shall be quarantined in the cold storage.
Article 76: Acceptance of medicines shall be conducted by checking the inspection report of the same batch number according to the medicine batch number. If the supplier is a wholesale enterprise, the inspection report shall be stamped with its special quality management seal. The transmission and storage of inspection reports can be in electronic data form, but their legality and validity must be ensured.
Article 77: Enterprises shall conduct batch-by-batch sampling acceptance of each batch of incoming medicines according to acceptance regulations, and the samples taken shall be representative.
(1) At least one smallest package of medicines with the same batch number shall be inspected, but if the manufacturer has special quality control requirements or opening the smallest package may affect the quality of the medicine, the smallest package may not be opened;
(2) For packaging abnormalities such as damage, contamination, leakage, broken seals, as well as loose goods or mixed boxes, the box shall be opened and inspected down to the smallest package;
(3) Raw materials with intact outer packaging and seals, and biological products under batch release management, may be inspected without opening the box.
Article 78: Acceptance personnel shall inspect and verify the appearance, packaging, labels, instructions, and related certification documents of the sampled medicines one by one; after acceptance, the intact samples taken shall be returned to the original packaging box, sealed, and marked.
Article 79: Specially managed medicines shall be accepted in a dedicated warehouse or designated area according to relevant regulations.
Article 80: Acceptance records of medicines shall be properly kept, including the generic name, dosage form, specification, approval number, batch number, production date, expiration date, manufacturer, supplier, quantity received, date of receipt, quantity accepted, acceptance results, and other contents. Acceptance personnel shall sign their name and acceptance date on the acceptance record.
Acceptance records for Chinese medicinal materials shall include the name, origin, supplier, quantity received, and quantity accepted. Acceptance records for Chinese herbal pieces shall include the name, specification, batch number, origin, production date, manufacturer, supplier, quantity received, and quantity accepted. For Chinese herbal pieces under approval number management, the approval number shall also be recorded.
For medicines that fail acceptance, the non-conformity issues and disposal measures shall also be noted.
Article 81: For medicines under electronic supervision, enterprises shall scan the electronic supervision code of the medicine as required and promptly upload the data to the China Drug Electronic Supervision Network system platform.
Article 82: Enterprises shall refuse to accept medicines that do not have the China Drug Electronic Supervision Code printed or affixed as required, or whose code printing does not meet the specified requirements. If the supervision code information does not match the medicine packaging information, the supplier shall be queried promptly, and the medicine shall not be warehoused before confirmation. If necessary, report to the local drug regulatory authority.
Article 83: Enterprises shall establish inventory records. Medicines that pass acceptance shall be promptly registered into inventory; medicines that fail acceptance shall not be warehoused and shall be handled by the quality management department.
Article 84: Enterprises conducting direct drug transfer according to Article 69 of this specification may entrust the purchasing unit to carry out drug acceptance. The purchasing unit shall strictly accept medicines and perform electronic supervision code scanning and data uploading according to this specification, and establish a dedicated direct transfer drug acceptance record. On the day of acceptance, the acceptance record information shall be transmitted to the direct transfer enterprise.
Section 10 Storage and Maintenance
Article 85: Enterprises shall store medicines reasonably according to their quality characteristics and meet the following requirements:
(1) Store medicines according to the temperature requirements indicated on the packaging. If no specific temperature is indicated, store according to the storage requirements specified in the Pharmacopoeia of the People's Republic of China;
(2) The relative humidity for storing medicines shall be 35% to 75%;
(3) In warehouses with manual operations, implement color-coded management according to quality status: green for qualified medicines, red for unqualified medicines, and yellow for medicines pending determination;
(4) Storage of medicines shall take measures such as avoiding light, shading, ventilation, moisture-proofing, insect-proofing, and rodent-proofing as required;
(5) Handling and stacking of medicines shall strictly follow the requirements indicated on the outer packaging, with stacking height complying with packaging illustrations to avoid damage to medicine packaging;
(6) Medicines shall be stacked by batch number; medicines of different batch numbers shall not be mixed in the same stack. The spacing between stacks shall be no less than 5 centimeters, the distance from the warehouse walls, ceiling, temperature control equipment, and pipelines shall be no less than 30 centimeters, and the distance from the ground shall be no less than 10 centimeters;
(7) Medicines shall be stored separately from non-medicines, external-use medicines shall be stored separately from other medicines, and Chinese medicinal materials and Chinese herbal pieces shall be stored separately;
(8) Specially managed medicines shall be stored according to relevant national regulations;
(9) Loose medicines with removed outer packaging shall be stored centrally;
(10) Shelves, pallets, and other facilities and equipment used for storing medicines shall be kept clean, without damage or clutter;
(11) Unauthorized personnel shall not enter the storage operation area, and personnel in the storage operation area shall not engage in behaviors that affect medicine quality and safety;
(12) Items unrelated to storage management shall not be stored in the medicine storage operation area.
Article 86: Maintenance personnel shall maintain medicines according to warehouse conditions, external environment, and medicine quality characteristics. The main contents are:
(1) Guide and supervise storage personnel to store and operate medicines properly;
(2) Inspect and improve storage conditions, protective measures, and sanitary environment;
(3) Effectively monitor and regulate warehouse temperature and humidity;
(4) Inspect the appearance, packaging, and other quality conditions of inventory medicines according to the maintenance plan and establish maintenance records; varieties with special storage requirements or short shelf life shall be given focused maintenance;
(5) Medicines found to have problems shall be promptly locked and recorded in the computer system and the quality management department notified for handling;
(6) Chinese medicinal materials and Chinese herbal pieces shall be maintained according to their characteristics using effective methods and recorded; the maintenance methods used shall not contaminate the medicines;
(7) Regularly summarize and analyze maintenance information.
Article 87 Enterprises shall use computer systems to automatically track and control the expiration dates of inventory drugs, take measures such as near-expiry warnings and automatic locking of expired drugs to prevent the sale of expired drugs.
Article 88 When drugs leak liquid, gas, or powder due to damage, safety handling measures shall be taken promptly to prevent contamination of the storage environment and other drugs.
Article 89 Drugs suspected of quality issues shall be immediately stopped from sale and locked in the computer system, and reported to the quality management department for confirmation. The following measures shall be taken for drugs with quality problems:
(1) Stored in a clearly marked dedicated place and effectively isolated, not for sale;
(2) If suspected to be counterfeit drugs, promptly report to the drug supervision and administration department;
(3) Drugs under special management shall be handled in accordance with relevant national regulations;
(4) The handling process of unqualified drugs shall have complete procedures and records;
(5) The causes of unqualified drugs shall be identified and analyzed, and preventive measures shall be taken promptly.
Article 90 Enterprises shall regularly inventory stock drugs to ensure consistency between accounts and goods.
Section 11 Sales
Article 91 Enterprises shall sell drugs to legitimate purchasing units and verify the proof documents of the purchasing units, as well as the identity of purchasing and receiving personnel, to ensure the authenticity and legality of drug sales flow.
Article 92 Enterprises shall strictly review the production scope, business scope, or diagnosis and treatment scope of the purchasing units and sell drugs according to the corresponding scope.
Article 93 Enterprises shall issue invoices truthfully when selling drugs, ensuring consistency among invoices, accounts, goods, and payments.
Article 94 Enterprises shall keep good records of drug sales. Sales records shall include the generic name, specification, dosage form, batch number, expiration date, manufacturer, purchasing unit, sales quantity, unit price, amount, sales date, and other content. For direct drug transfers according to Article 69 of this specification, special sales records shall be established.
Sales records of Chinese medicinal materials shall include the name, specification, origin, purchasing unit, sales quantity, unit price, amount, sales date, etc.; sales records of Chinese herbal pieces shall include the name, specification, batch number, origin, manufacturer, purchasing unit, sales quantity, unit price, amount, sales date, etc.
Article 95 The sale of specially managed drugs and drugs with special national management requirements shall be strictly implemented in accordance with relevant national regulations.
Section 12 Outbound
Article 96 Outbound shipments shall be reviewed against sales records. The following situations shall not be allowed for outbound shipment and shall be reported to the quality management department for handling:
(1) Drug packaging is damaged, contaminated, poorly sealed, improperly padded, or seal damaged;
(2) Abnormal sounds or liquid leakage inside the packaging;
(3) Labels are detached, illegible, or the label content does not match the actual product;
(4) Drugs have exceeded the expiration date;
(5) Other abnormal conditions of drugs.
Article 97 Drug outbound review shall establish records including purchasing unit, drug generic name, dosage form, specification, quantity, batch number, expiration date, manufacturer, outbound date, quality status, and reviewer.
Article 98 Outbound of specially managed drugs shall be reviewed in accordance with relevant regulations.
Article 99 Substitute packaging boxes for mixed drug shipments shall have conspicuous mixed shipment marks.
Article 100 When drugs are shipped out, a delivery note (ticket) with the company's special drug outbound seal shall be attached.
For direct drug transfers according to Article 69 of this specification, the supplying unit shall issue two delivery notes (tickets) when shipping out direct transfer drugs, sent respectively to the direct transfer enterprise and the purchasing unit. The content of the delivery notes (tickets) shall comply with the requirements of the second paragraph of Article 73 of this specification and shall also indicate the name of the direct transfer enterprise.
Article 101 The packing and loading of refrigerated and frozen drugs shall be handled by designated personnel and meet the following requirements:
(1) Vehicle-mounted refrigerated boxes or insulated boxes shall reach the required temperature before use;
(2) Packing and sealing of refrigerated and frozen drugs shall be completed in a refrigerated environment;
(3) Before loading, the refrigerated vehicle's start-up and operating status shall be checked, and loading shall only proceed after reaching the specified temperature;
(4) Transportation records shall be made at departure, including transport tools and departure time.
Article 102 For drugs under electronic supervision, scanning and data uploading shall be performed at outbound shipment.
Section 13 Transportation and Distribution
Article 103 Enterprises shall strictly implement transportation operation procedures according to quality management system requirements and take effective measures to ensure drug quality and safety during transportation.
Article 104 When transporting drugs, appropriate transport tools shall be selected based on drug packaging, quality characteristics, and factors such as vehicle condition, road, and weather, and corresponding measures shall be taken to prevent damage and contamination.
Article 105 Before shipping drugs, transport tools shall be inspected. If transport conditions do not meet regulations, shipment shall not proceed. During drug transportation, transport tools shall remain sealed.
Article 106 Enterprises shall handle and load/unload drugs strictly according to the requirements marked on the outer packaging.
Article 107 Enterprises shall take necessary insulation or refrigeration/freezing measures during transportation according to the drug's temperature control requirements.
During transportation, drugs shall not come into direct contact with ice packs, ice plates, or other cold storage agents to prevent affecting drug quality.
Article 108 During the transportation of refrigerated and frozen drugs, temperature data inside refrigerated vehicles, refrigerated boxes, or insulated boxes shall be monitored and recorded in real time.
Article 109 Enterprises shall formulate emergency plans for the transportation of refrigerated and frozen drugs, and be able to take corresponding response measures for emergencies such as equipment failure, abnormal weather impact, and traffic congestion that may occur during transportation.
Article 110 When enterprises entrust other units to transport drugs, they shall audit the carrier's ability to ensure the quality of drug transportation, request relevant information about the transport vehicles, and only entrust those that meet the conditions and requirements of transportation facilities and equipment specified in this standard.
Article 111 Enterprises entrusting drug transportation shall sign a transportation agreement with the carrier, clarifying responsibilities for drug quality, compliance with transportation operation procedures, and transit time limits.
Article 112 Enterprises entrusting drug transportation shall keep records to achieve quality traceability during transportation. Records shall at least include shipment time, shipment address, receiving unit, receiving address, waybill number, number of drug packages, transportation method, entrusted handler, carrier unit; if transported by vehicle, the license plate number shall also be recorded, and a copy of the driver's license shall be retained. Records shall be kept for at least 5 years.
Article 113 Drugs that have been loaded onto vehicles shall be dispatched promptly and delivered as soon as possible. For entrusted transportation, enterprises shall require and supervise the carrier to strictly fulfill the entrusted transportation agreement to prevent drug quality from being affected by excessive transit time.
Article 114 Enterprises shall take transportation safety management measures to prevent incidents such as drug theft, loss, or substitution during transportation.
Article 115 The transportation of specially managed drugs shall comply with relevant national regulations.
Section 14 After-sales Management
Article 116 Enterprises shall strengthen the management of returned goods to ensure the quality and safety of drugs in the return process and prevent counterfeit drugs from being mixed in.
Article 117 Enterprises shall formulate complaint management operation procedures according to quality management system requirements, including complaint channels and methods, record keeping, investigation and evaluation, handling measures, feedback, and follow-up.
Article 118 Enterprises shall assign full-time or part-time personnel responsible for after-sales complaint management, investigate the causes of quality complaints, take effective measures for timely handling and feedback, keep records, and notify the supplier and drug manufacturer when necessary.
Article 119 Enterprises shall promptly record complaints and handling results in archives for inquiry and tracking.
Article 120 If enterprises discover serious quality problems in sold drugs, they shall immediately notify the purchasing unit to stop sales and recall the drugs, keep records, and report to the drug supervision and administration department.
Article 121 Enterprises shall assist drug manufacturers in fulfilling recall obligations, promptly convey and feedback drug recall information according to the recall plan, control and recover drugs with safety hazards, and establish drug recall records.
Article 122 The enterprise quality management department shall assign full-time or part-time personnel to undertake adverse drug reaction monitoring and reporting work in accordance with relevant national regulations.
Chapter 3 Quality Management of Drug Retail
Section 1 Quality Management and Responsibilities
Article 123 Enterprises shall formulate quality management documents and carry out quality management activities in accordance with relevant laws, regulations, and the requirements of this standard to ensure drug quality.
Article 124 Enterprises shall have operating conditions compatible with their business scope and scale, including organizational structure, personnel, facilities and equipment, quality management documents, and shall set up computer systems as required.
Article 125 The person in charge of the enterprise is the main responsible person for drug quality, responsible for daily management, providing necessary conditions, ensuring that the quality management department and personnel effectively perform their duties, and ensuring the enterprise operates drugs according to this standard.
Article 126 Enterprises shall set up a quality management department or assign quality management personnel to perform the following duties:
(1) Urge relevant departments and personnel to implement drug management laws, regulations, and these regulations;
(2) Organize the formulation of quality management documents and guide and supervise their implementation;
(3) Responsible for reviewing the qualification certificates of suppliers and their sales personnel;
(4) Responsible for reviewing the legality of purchased drugs;
(5) Responsible for drug acceptance, guiding and supervising quality management in drug procurement, storage, display, sales, and other links;
(6) Responsible for drug quality inquiries and quality information management;
(7) Responsible for investigating, handling, and reporting drug quality complaints and quality incidents;
(8) Responsible for confirming and handling unqualified drugs;
(9) Responsible for reporting counterfeit and inferior drugs;
(10) Responsible for reporting adverse drug reactions;
(11) Conduct drug quality management education and training;
(12) Responsible for reviewing and controlling computer system operation permissions and maintaining basic quality management data;
(13) Responsible for organizing the calibration and verification of measuring instruments;
(14) Guide and supervise pharmaceutical services;
(15) Other duties that should be performed by the quality management department or personnel.
Section 2 Personnel Management
Article 127 Personnel engaged in drug business and quality management shall meet the qualification requirements stipulated by relevant laws, regulations, and this standard, and shall not have circumstances prohibited by relevant laws and regulations.
Article 128 The legal representative or person in charge of the enterprise shall have the qualification of a licensed pharmacist.
Enterprises shall assign licensed pharmacists according to national regulations, responsible for prescription review and guiding rational drug use.
Article 129 Quality management, acceptance, and procurement personnel shall have academic qualifications in pharmacy, medicine, biology, chemistry, or related fields, or hold professional titles in pharmacy. Personnel engaged in quality management, acceptance, and procurement of traditional Chinese medicine decoction pieces shall have at least a secondary specialized education in traditional Chinese medicine or hold junior or above professional titles in traditional Chinese medicine.
Salespersons shall have a high school education or above or meet the conditions stipulated by the provincial drug supervision department. Personnel dispensing traditional Chinese medicine decoction pieces shall have at least a secondary specialized education in traditional Chinese medicine or possess qualifications as traditional Chinese medicine dispensers.
Article 130 Personnel in various positions of the enterprise shall receive pre-job and continuing training on relevant laws, regulations, and professional knowledge and skills of drugs to meet the requirements of this standard.
Article 131 Enterprises shall formulate annual training plans and carry out training according to the training management system, enabling relevant personnel to correctly understand and perform their duties. Training work shall be properly recorded and archived.
Article 132 Enterprises shall provide conditions for personnel selling specially managed drugs, drugs with special national management requirements, and refrigerated drugs to receive corresponding training, enabling them to master relevant laws, regulations, and professional knowledge.
Article 133 Within business premises, enterprise staff shall wear clean and hygienic work clothes.
Article 134 Enterprises shall conduct pre-employment and annual health checks for personnel directly contacting drugs and establish health records. Those suffering from infectious diseases or other diseases that may contaminate drugs shall not engage in work directly contacting drugs.
Article 135 Items unrelated to business activities and personal belongings shall not be stored in drug storage, display, and other areas. Behaviors affecting drug quality and safety are prohibited in work areas.
Section 3 Documents
Article 136 Enterprises shall formulate quality management documents that conform to the actual situation of the enterprise in accordance with relevant laws, regulations, and this specification. Documents include quality management systems, job responsibilities, operating procedures, archives, records, and certificates, and shall be regularly reviewed and promptly revised.
Article 137 Enterprises shall take measures to ensure that personnel at all positions correctly understand the content of quality management documents and ensure the effective implementation of these documents.
Article 138 The quality management system for drug retail shall include the following content:
(1) Management of drug procurement, acceptance, display, sales, and if a warehouse is set up, it shall also include storage and maintenance management;
(2) Review of suppliers and purchased varieties;
(3) Management of prescription drug sales;
(4) Management of drug splitting;
(5) Management of specially managed drugs and drugs with special national management requirements;
(6) Management of records and certificates;
(7) Management of collection and inquiry of quality information;
(8) Management of quality incidents and quality complaints;
(9) Management of prescription review, dispensing, and verification of Chinese herbal pieces;
(10) Management of drug expiration dates;
(11) Management of unqualified drugs and drug destruction;
(12) Regulations on environmental hygiene and personnel health;
(13) Management of pharmaceutical services such as providing medication consultation and guiding rational drug use;
(14) Regulations on personnel training and assessment;
(15) Regulations on adverse drug reaction reporting;
(16) Management of computer systems;
(17) Regulations on implementing electronic drug supervision;
(18) Other contents that should be stipulated.
Article 139 Enterprises shall clarify the responsibilities of enterprise leaders, quality management, procurement, acceptance, sales staff, as well as prescription review and dispensing positions. If a warehouse is set up, it shall also include responsibilities for storage and maintenance positions.
Article 140 The responsibilities of quality management positions and prescription review positions shall not be performed by personnel from other positions on their behalf.
Article 141 The drug retail operating procedures shall include:
(1) Drug procurement, acceptance, and sales;
(2) Prescription review, dispensing, and verification;
(3) Prescription review, dispensing, and verification of Chinese herbal pieces;
(4) Drug splitting sales;
(5) Sales of specially managed drugs and drugs with special national management requirements;
(6) Drug display and inspection in business premises;
(7) Storage of refrigerated drugs in business premises;
(8) Operation and management of computer systems;
(9) If a warehouse is set up, it shall also include operating procedures for storage and maintenance.
Article 142 Enterprises shall establish relevant records for drug procurement, acceptance, sales, display inspection, temperature and humidity monitoring, and handling of unqualified drugs, ensuring they are true, complete, accurate, effective, and traceable.
Article 143 Records and related certificates shall be kept for at least 5 years. Records and certificates of specially managed drugs shall be kept according to relevant regulations.
Article 144 When recording data through computer systems, relevant personnel shall enter data according to operating procedures, logging into the computer system through authorization and password, ensuring the data is original, true, accurate, secure, and traceable.
Article 145 Electronic record data shall be regularly backed up in a safe and reliable manner.
Section 4 Facilities and Equipment
Article 146 The business premises of enterprises shall be appropriate to their drug business scope and scale, and shall be separated from drug storage, office, living auxiliary, and other areas.
Article 147 Business premises shall have corresponding facilities or take other effective measures to prevent drugs from being affected by the outdoor environment, and shall be spacious, bright, clean, and hygienic.
Article 148 Business premises shall have the following business equipment:
(1) Shelves and counters;
(2) Equipment for monitoring and regulating temperature;
(3) For businesses dealing with Chinese herbal pieces, equipment for storing pieces and prescription dispensing;
(4) For businesses dealing with refrigerated drugs, dedicated refrigeration equipment;
(5) For businesses dealing with Class II psychotropic drugs, toxic Chinese medicines, and poppy shells, dedicated storage equipment that meets safety regulations;
(6) Dispensing tools and packaging materials required for drug splitting sales.
Article 149 Enterprises shall establish computer systems that meet business and quality management requirements and satisfy the implementation conditions of electronic drug supervision.
Article 150 Enterprises setting up warehouses shall ensure that the interior walls and ceiling of the warehouse are smooth, the floor is level, and the doors and windows are tightly sealed; reliable safety protection and anti-theft measures shall be in place.
Article 151 Warehouses shall have the following facilities and equipment:
(1) Equipment that effectively isolates drugs from the ground;
(2) Equipment for light protection, ventilation, moisture prevention, pest control, and rodent prevention;
(3) Equipment for effective monitoring and regulation of temperature and humidity;
(4) Lighting equipment that meets storage operation requirements;
(5) Dedicated acceptance area;
(6) Dedicated storage area for substandard drugs;
(7) For businesses dealing with refrigerated drugs, there shall be dedicated equipment appropriate to the types and scale of the business.
Article 152 Businesses dealing with specially managed drugs shall have storage facilities that comply with national regulations.
Article 153 Dedicated warehouses shall be established for storing traditional Chinese medicine decoction pieces.
Article 154 Enterprises shall regularly calibrate or verify measuring instruments, temperature and humidity monitoring equipment, etc., in accordance with relevant national regulations.
Section 5 Procurement and Acceptance
Article 155 Enterprises purchasing drugs shall comply with the relevant provisions of Chapter 2, Section 8 of this specification.
Article 156 Upon drug arrival, receiving personnel shall verify the physical drugs against the purchase records and the accompanying delivery documents from the supplier, ensuring consistency among the documents, accounts, and goods.
Article 157 Enterprises shall inspect incoming drugs batch by batch according to prescribed procedures and requirements, and keep acceptance records in accordance with Article 80 of this specification.
Samples taken for acceptance shall be representative.
Article 158 Refrigerated drugs upon arrival shall be inspected according to the provisions of Article 74 of this specification.
Article 159 Drug acceptance shall include verification of drug inspection reports in accordance with Article 76 of this specification.
Article 160 Specially managed drugs shall be accepted in accordance with relevant regulations.
Article 161 Drugs that pass acceptance shall be promptly stored or shelved. For drugs under electronic supervision, scanning and data uploading shall be performed according to Articles 81 and 82 of this specification. Drugs that fail acceptance shall not be stored or shelved and must be reported to quality management personnel for handling.
Section 6 Display and Storage
Article 162 Enterprises shall monitor and regulate the temperature of business premises to ensure it meets room temperature requirements.
Article 163 Enterprises shall conduct regular hygiene inspections to maintain a clean environment. Equipment used for storing and displaying drugs shall be kept clean and sanitary, unrelated items shall not be placed there, and measures such as pest and rodent control shall be taken to prevent drug contamination.
Article 164 Drug display shall meet the following requirements:
(1) Drugs shall be displayed classified by dosage form, use, and storage requirements, with clear and accurate category labels and prominent signs;
(2) Drugs shall be placed neatly and orderly on shelves (cabinets), avoiding direct sunlight exposure;
(3) Prescription drugs and over-the-counter drugs shall be displayed separately, with dedicated signs for each;
(4) Prescription drugs shall not be displayed or sold by open shelf self-selection;
(5) External use drugs shall be placed separately from other drugs;
(6) Drugs sold in split packages shall be stored centrally in dedicated split-package counters or areas;
(7) Class II psychotropic drugs, toxic traditional Chinese medicines, and poppy shells shall not be displayed;
(8) Refrigerated drugs shall be placed in refrigeration equipment, with temperature monitored and recorded as required, ensuring storage temperature compliance;
(9) The labeling of traditional Chinese medicine decoction piece drawers shall be accurate and correct; drawers shall be checked before filling to prevent misplacement or mixing; drawers shall be cleaned regularly to prevent infestation, mold, or deterioration; drawers shall be cleaned and recorded before filling with decoction pieces of different batch numbers;
(10) Non-drug items shall be placed in designated areas, clearly separated from drug areas, with prominent signs.
Article 165 Enterprises shall regularly inspect displayed and stored drugs, focusing on split-package drugs, perishable drugs, drugs nearing expiration, drugs stored for a long time, and traditional Chinese medicine decoction pieces. Drugs with quality concerns shall be promptly removed from shelves, sales stopped, confirmed and handled by quality management personnel, and relevant records retained.
Article 166 Enterprises shall track and manage drug expiration dates to prevent the sale and use of expired drugs after nearing expiration.
Article 167 For enterprises with warehouses, the storage and maintenance management of drugs in the warehouse shall comply with the relevant provisions of Chapter 2, Section 10 of this specification.
Section 7 Sales Management
Article 168 Enterprises shall prominently display the "Drug Business License", business license, licensed pharmacist registration certificate, and other relevant certificates at the business premises.
Article 169 Sales personnel shall wear work badges with photo, name, and position. For licensed pharmacists and pharmaceutical technical personnel, the badge shall also indicate professional qualifications or pharmaceutical technical titles. Licensed pharmacists on duty shall display their badges clearly.
Article 170 Drug sales shall meet the following requirements:
(1) Prescriptions shall be reviewed by licensed pharmacists before dispensing; drugs listed on the prescription shall not be changed or substituted without authorization; prescriptions with contraindications or overdoses shall be refused, but may be dispensed if corrected or re-signed by the prescribing physician; drugs may be sold only after dispensing and verification;
(2) Personnel reviewing, dispensing, and verifying prescriptions shall sign or stamp the prescription and keep the prescription or its copy according to relevant regulations;
(3) Customers shall be informed of the expiration date when selling drugs nearing expiration;
(4) When selling traditional Chinese medicine decoction pieces, ensure accurate measurement and inform customers of the decoction method and precautions; providing decoction services for traditional Chinese medicine decoction pieces must comply with relevant national regulations.
Article 171 Enterprises selling medicines shall issue sales vouchers, including the medicine name, manufacturer, quantity, price, batch number, specifications, etc., and keep sales records.
Article 172 The sale of medicines in broken packages shall meet the following requirements:
(1) Personnel responsible for broken package sales must receive specialized training;
(2) The workbench and tools used for breaking packages must be kept clean and hygienic to prevent cross-contamination;
(3) Keep records of broken package sales, including the start date of breaking, the generic name of the medicine, specifications, batch number, manufacturer, expiration date, sales quantity, sales date, personnel who split and reviewed the packages, etc.;
(4) Broken package sales must use clean and hygienic packaging, with the packaging clearly indicating the medicine name, specifications, quantity, usage, dosage, batch number, expiration date, and pharmacy name;
(5) Provide the original or a copy of the medicine instruction leaflet;
(6) During the period of broken package sales, retain the original packaging and instruction leaflet.
Article 173 The sale of specially controlled medicines and medicines with special national management requirements shall strictly comply with relevant national regulations.
Article 174 Medicine advertising and promotion shall strictly comply with relevant national advertising management regulations.
Article 175 Non-employees of the enterprise shall not engage in medicine sales-related activities within the business premises.
Article 176 For medicines subject to electronic supervision, scanning and data uploading shall be performed at the time of sale.
Section 8 After-sales Management
Article 177 Except for quality reasons, medicines once sold shall not be returned or exchanged.
Article 178 Enterprises shall publish the supervision telephone number of the drug regulatory authority at the business premises, set up a customer opinion book, and promptly handle customer complaints about medicine quality.
Article 179 Enterprises shall collect and report adverse drug reaction information in accordance with the national adverse drug reaction reporting system.
Article 180 If an enterprise discovers serious quality problems in sold medicines, it shall promptly take measures to recall the medicines and keep records, and report to the drug regulatory authority.
Article 181 Enterprises shall assist pharmaceutical manufacturers in fulfilling recall obligations, control and recover medicines with safety hazards, and establish medicine recall records.
Chapter 4 Supplementary Provisions
Article 182 The management of the headquarters of pharmaceutical retail chain enterprises shall comply with the relevant provisions for pharmaceutical wholesale enterprises in this standard, and the management of stores shall comply with the relevant provisions for pharmaceutical retail enterprises in this standard.
Article 183 This standard is the basic requirement for quality management of pharmaceutical operations. Specific requirements for enterprise information management, automatic monitoring of drug storage and transportation temperature and humidity, drug acceptance management, cold chain logistics management, retail chain management, etc., shall be separately formulated by the National Medical Products Administration in the form of appendices.
Article 184 The meanings of the following terms in this standard are:
(1) On-duty: Registered personnel who have established a labor relationship with the enterprise.
(2) On-post: Relevant personnel performing duties at the designated post during working hours.
(3) First-time supplier enterprise: A pharmaceutical manufacturer or operator that establishes a supply relationship with the enterprise for the first time when purchasing medicines.
(4) First-time purchased variety: Medicines purchased by the enterprise for the first time.
(5) Original seal: The original imprint of the enterprise's official seal, special invoice seal, quality management special seal, or drug dispatch special seal stamped on relevant documents or vouchers during purchase and sales activities to prove the enterprise's identity; it cannot be a printed, photocopied, or copied imprint.
(6) Pending inspection: The status of medicines that have arrived or been returned after sale, isolated or distinguished by effective means, awaiting quality inspection before storage.
(7) Loose goods: Medicines whose transportation and storage packaging has been removed.
(8) Consolidated shipment: The method of gathering loose medicines into the same packaging box for shipment.
(9) Broken package sales: The method of selling medicines by splitting the smallest packaging.
(10) Medicines with special national management requirements: Medicines subject to special regulatory measures by the state, such as anabolic agents, peptide hormones, and compound preparations containing special medicines.
Article 185 The quality management standards for medicine procurement, storage, and maintenance in medical institution pharmacies and family planning technical service institutions shall be separately formulated by the National Medical Products Administration in consultation with relevant authorities.
Quality management regulations for internet sales of medicines shall be separately formulated by the National Medical Products Administration.
Article 186 Pharmaceutical operating enterprises that violate this standard shall be punished by the drug regulatory authority in accordance with Article 79 of the "Drug Administration Law of the People's Republic of China."
Article 187 This standard shall come into effect on June 1, 2013. In accordance with Article 16 of the "Drug Administration Law of the People's Republic of China," the specific implementation methods and steps shall be stipulated by the National Medical Products Administration.
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