Drug Operation Quality Management Specification (Ministry of Health Order No. 90)
"Specifications for the Management of Drug Operations" was reviewed and approved by the Ministry of Health's Ministry of Health on November 6, 2012，Now announced，From June 1, 2013。
Minister Chen Zhu
January 22, 2013
Drug business quality management specifications
Chapter 1 General Principles
Article 1 In order to strengthen the quality management of drug management，Standardized drug business behavior，Guarantee human medication safety、Effective，According to the "Drug Management Law of the People's Republic of China"、"Implementation Regulations of the People's Republic of China Drug Administration Law"，Develop this specification。
Article 2 This specification is the basic criterion for drug management and quality control，Enterprises should purchase in drugs、Storage、Sales、Transportation and other links take effective quality control measures，Make sure the quality of the medicine。
Article 3 Drug business enterprises shall strictly implement this specification。
Drug production enterprises sell drugs、Others involved in storage and transportation drugs during the process of drug circulation，It should also meet the relevant requirements of this specification。
4 Drug business enterprises shall adhere to honesty and trustworthy，Operation according to law。No false falsege、Deception behavior。
Chapter 2 Quality Management of Drug Wholesale
The first quality management system
5 Enterprises shall establish a quality management system in accordance with the requirements of relevant laws and regulations and the requirements of these specifications，Determine quality policy，Establish a quality management system document，Carry out quality planning、Quality Control、Quality Assurance、Quality improvement and quality risk management activities。
6 The quality policy documents formulated by an enterprise shall clarify the total quality goals and requirements of the enterprise，and implement the whole process of drug business activities。
7 The enterprise quality management system shall be compatible with its business scope and scale，Including organizations、Personnel、Facilities and equipment、Quality Management System File and the corresponding computer system。
Article 8 Enterprises shall be regularly and when the key elements of the quality management system will change significantly，Organization to carry out internal trials。
1 The enterprise shall analyze the internal review situation，Formulate improvement measures for the quality management system according to analysis conclusions，Continuous improvement of quality control，Guarantee the quality management system continues to run effectively。
Article 10 Enterprises shall adopt a forward -looking or retrospective method，Evaluate the quality risk in the process of drug circulation、Control、Communication and review。
11 Enterprise shall be a pharmaceutical supply unit、Evaluation of the quality management system of the purchase unit，Confirm its quality assurance ability and quality reputation，On -site inspection if necessary。
Article 12 Enterprises shall participate in quality management。All departments、The staff should understand and fulfill their duties correctly，Responsibility responsibility for quality。
Section 2 Organization and Quality Management Responsibilities
Article 13 Enterprises shall establish an organization or position that is compatible with its business activities and quality management，Determine its responsibilities、permissions and relationships。
Article 14 The person in charge of an enterprise is the main responsible person of the quality of medicine，Comprehensive responsible for the daily management of the enterprise，Responsible for providing the necessary conditions，Ensure that the quality management department and quality management personnel effectively perform their duties，Ensure that the enterprise achieves quality goals and operates drugs in accordance with this specification。
Article 15 The person in charge of the enterprise shall be held by high -level managers，Comprehensive responsible for drug quality management work，Independent performance responsibilities，It has the right to decide on the quality management of drugs within the enterprise。
Article 16 Enterprises shall set up a quality management department，Effective quality management work。The responsibilities of the quality management department shall not be fulfilled by other departments and personnel。
Article 17 The quality management department shall fulfill the following responsibilities:
(1) Supervise the laws and regulations and specifications of relevant departments and post personnel to implement drug management;
(2) Organization formulate a quality management system document，Guide、The execution of the supervision file;
(3) Responsible for the legitimacy of the supply unit and purchase unit、The legitimacy of the purchase of medicines and the sales staff of the supplier、The legal qualifications of the purchasing unit purchases for review，and conduct dynamic management based on changes in the review content;
(4) Responsible for the collection and management of quality information，Create a drug quality file;
(5) Responsible for the acceptance of drugs，Guidance and supervise drug purchase、Storage、Maintenance、Sales、Return、Quality management of transportation and other links;
(6) Responsible for confirmation of unqualified drugs，Supervise the processing process of non -qualified medicines;
(7) Responsible for the survey of drug quality complaints and quality accidents、Treatment and report;
(8) Responsible for the report of false and inferior drugs;
(9) Responsible for drug quality query;
(10) Responsible for guiding the setting of the computer system quality control function;
(11) Responsible for the review and renewal of basic data of quality management and quality management;
(12) Organize verification and calibration related facilities and equipment;
(13) Responsible for the management of drug recall;
(14) Report responsible for adverse drug reactions;
(15) Internal review and risk assessment of the organizational quality management system;
(16) Organize the inspection and evaluation of the quality management system and service quality of drug supply units and purchase units;
(17) The organization reviews the transportation conditions and quality assurance capabilities of the transportation of the commissioned transportation;
(18) Assisting quality management education and training;
(19) Other responsibilities should be performed by the quality management department。
Section 3 Personnel and Training
Article 18 Enterprises who are engaged in drug management and quality management，The qualification requirements stipulated in relevant laws and regulations and the requirements of these specifications，There must be no relevant laws and regulations to prohibit employment。
Article 19 The person in charge of an enterprise shall have a college degree or above or a professional and technical title of secondary or above，Basic pharmaceutical professional knowledge training，Familiar with laws and regulations on drug management and this specification。
Article 20 The person in charge of the quality of an enterprise shall have a bachelor's degree or above、Qualification of Practice Pharmacist and Experience of the Quality Management of Drugs for more than 3 years，The ability to correctly judge and guarantee implementation in quality management。
Twenty，Can solve the quality problems in the business process independently。
Article 22 Enterprise shall be equipped with quality management that meets the requirements of the following qualifications、Acceptance and maintenance personnel:
(1) For quality management work，It should have a pharmaceutical technical secondary school or medicine、Bio、Chemistry and other related college colleges or above, or have professional titles with primary or above pharmaceutical primary or above;
(2) Acceptance、Conservation work，It should have medicine or medicine、Bio、Chemistry and other related majors in secondary school or above, or have professional titles with primary or above pharmaceuticals;
(3) engaged in Chinese medicinal materials、The acceptance of Chinese medicine drinking tablets，It should have a secondary degree or above in Chinese medicine or middle -level professional technical titles; engaged in Chinese medicinal materials、Maintenance of Chinese Medicine Drinking Film，It should have a secondary degree or above in the secondary school or above of Chinese medicine, or there is a Stake Sports Bettingprofessional titles of junior high schools or above in Chinese medicine;，Acceptance personnel should have professional titles in middle -level or above Chinese medicine。
Enterprises operating vaccines should also be equipped with more than 2 professional and technical personnel responsible for vaccine quality management and acceptance，Professional and technical personnel should have preventive medicine、Pharmacy、Microbiology or Medicine's undergraduate degree or above, and professional titles above the intermediate level or above，and have more than 3 years of vaccine management or technical work experience。
Article 23 engaged in quality management、Personnel who accepts acceptance should be on -the -job，No part -time other business work。
Twenty -four personnel engaged in procurement shall have pharmacy or medicine、Bio、Chemistry and other related majors in secondary school or above，Sales、Storage and other people should have the cultural level above high school。
Article 25 Enterprises shall provide personnel related to their responsibilities and work content related to their responsibilities and work content.，To meet the requirements of this specification。
Article 26 The training content shall include relevant laws and regulations、Drug professional knowledge and skills、Quality Management System、Responsibilities and job operating procedures, etc.。
Article 27 Enterprises shall formulate an annual training plan and carry out training in accordance with the training management system，enable relevant personnel to understand and fulfill their duties correctly。Training should record and establish a file。
28 Storage of medicines and refrigerated frozen drugs engaged in specially managed special management、Transportation and other personnel，It should be trained in relevant laws and regulations and professional knowledge and passed the assessment.。
Article 29 Enterprises shall formulate personal health management system for employees，Storage、The dressing of personnel such as transportation and other positions shall meet the requirements of labor protection and product protection。
Article 30 Quality Management、Acceptance、Maintenance、Storage and other personnel who directly contact drug positions shall conduct pre -post and annual health checks，Establish a health file。A disease with infectious diseases or other diseases that may pollute drugs，You must not engage in work that directly contacts medicines。The physical condition does not meet the specific requirements of the corresponding position，Do not engage in related work。
Fourth Sectional Quality Management System File
Article 31 Enterprise Formation of the Quality Management System Document shall meet the actual situation of the enterprise。The files include the quality management system、Department and post responsibility、Operation Regulations、File、Report、Records and vouchers。
Drafting of Article 32 of the file、Amendment、Audit、Approval、distribution、Keep，and modification、Rejuvenation、Replace、Destruction, etc. shall be carried out in accordance with the file management operating regulations，and save related records。
Article 33 Documents shall indicate the topic、Type、Purpose and file number and version number。The text should be accurate、Clear、Easy to understand。
Files shall be categorized and stored for easy consultation.
Article 34 Enterprise shall regularly review、Revised file，The file used should be an effective text，Documents that have been abolished or invalidated except for preparation for preparation，Do not appear at the work site。
Article 35 Enterprises shall ensure that each position is required to obtain the necessary documents corresponding to its work content，and work strictly in accordance with regulations。
Article 36 The quality management system shall include the following content:
(1) Regulations on the review of the quality management system;
(2) Regulations on quality veto;
(3) Management of quality management files;
(4) Management of Quality Information;
(5) Supplier unit、Buying unit、Regulations on qualification reviews such as sales staff and purchasing unit purchases of the supply unit;
(6) Pharmaceutical purchasing、Received goods、Acceptance、Storage、Maintenance、Sales、Out of the library、Transportation management;
(7) The regulations of specialized medicines;
(8) Management of the validity period of drugs;
(9) Management of non -qualified drugs and drugs;
(10) Management of drug returns;
(11) Management of drug recall;
(12) Management of Quality Inquiry;
(13) Management of quality accidents and quality complaints;
(14) Regulations on the report of adverse reaction reports;
(15) Regulations on environmental sanitation and personnel health;
(16) Education in quality、Training and assessment regulations;
(17) Management and maintenance of facilities and equipment;
(18) Management and calibration of facilities and equipment;
(19) Records and vouchers management;
(20) Management of computer system;
(21) Regulations on implementing drug electronic supervision;
(22) Other content that should be prescribed.
Article 37 of the departments and positions shall include:
(1) My stake betting appquality Stake Sports Bettingmanagement、Purchasing、Storage、Sales、Transportation、Finance and information management department responsibilities;
(2) The person in charge of the enterprise、Quality responsible person and My stake betting appquality Stake Sports Bettingmanagement、Purchasing、Storage、Sales、Transportation、The responsibilities of the person in charge of the department of finance and information management;
(3) My stake betting appquality Stake Sports Bettingmanagement、Purchasing、Received goods、Acceptance、Storage、Maintenance、Sales、Review of the warehouse、Transportation、Finance、Information management and other job responsibilities;
(4) Other positions related to drug management.
Article 38 Enterprises shall formulate drug procurement、Received goods、Acceptance、Storage、Maintenance、Sales、Review of the warehouse、Transportation and other links and operating regulations for computer systems。
Article 39 Enterprises shall establish drug procurement、Acceptance、Maintenance、Sales、Review of the warehouse、Return and purchase exit after sale、Transportation、Storage and Humidity Monitoring、Related records such as unqualified drug treatment，Be real、Full、Accurate、Effective and traceable。
Article 40 When recording data through a computer system，Relevant personnel shall follow the operating regulations，19271_19319，Records should be left in the change process。
Article 41 of the written records and vouchers shall be filled in time，and make clear the handwriting，Do not change at will，Do not tear。Change the record，The reason should be indicated、Date and signature，Keep the original information clear and distinguished。
Article 42 records and vouchers shall be stored for at least 5 years。Vaccine、The records and vouchers of specially managed drugs are stored in accordance with relevant regulations。
Section 5 Facilities and equipment
Article 43 Enterprises shall have the scope of business with their drugs、Business places and warehouses that are compatible with business scale。
Article 44 The location of the warehouse、Design、Layout、Construction、Reconstruction and maintenance shall meet the requirements of drug storage，Prevent drug pollution、Cross pollution、Confusion and error。
Article 45 of the drug storage operating area、The auxiliary operating area shall be separated from the office area and the living area to a certain distance or there are isolation measures。
Article 46 The scale and conditions of the warehouse shall meet the reasonable medicine、Safety storage，and meet the following requirements，Easy to carry out storage operations:
(1) The environment inside and outside the warehouse is neat，No pollution source，Division area hardening or greening;
(2) The inner wall of the warehouse、Top light，ground flat，The door and window structure is tight;
(3) The warehouse has reliable safety protection measures，Being able to implement controlled management of unrelated personnel，Prevent drugs from being stolen、Replace or mix fake medicine;
(4) Preventing outdoor loading and unloading、Moving、Receiving、Measures that are affected by abnormal weather are affected by abnormal weather。
Article 47 The warehouse shall be equipped with the following facilities and equipment:
(1) Effective isolation equipment between drugs and ground;
(2) Avoiding light、Ventilation、moisture -proof、Anti -insects、Rat -proof and other equipment;
(3) Effective adjustment of equipment with temperature and humidity and indoor and outdoor air exchange;
(4) Automatic monitoring、Equipment for the temperature and humidity of the warehouse;
(5) Lighting equipment that meets the requirements of storage operations;
(6) Used for potal selection、Lake -shiping operation and review of the operation area and equipment;
(7) Storage venue of packaging materials;
(8) Special places for acceptance, delivery, and return;
(9) Special storage places for unqualified drugs;
(10) Drugs operating special management have storage facilities that comply with national regulations。
Article 48 operating Chinese medicinal materials、Chinese medicine drinking tablets，There should be a dedicated warehouse and maintenance workplace，Direct acquisition of real estate Chinese medicinal materials shall set up a Chinese medicine sample room (cabinet)。
Article 49 Operating refrigerated、Frozen drugs，The following facilities and equipment should be equipped:
(1) Cold storage that is compatible with its business scale and variety，If you operate the vaccine, you should be equipped with more than two independent cold storage;
(2) Used for automatic monitoring of cold storage temperature、Show、Record、Regulation、Alarm equipment;
(3) The spare -generating unit or dual -circuit power supply system of the cold storage refrigeration equipment;
(4) Drugs with special low temperature requirements，It should be equipped with facilities and equipment that meets its storage requirements;
(5) Refueling and car refrigerated boxes or insulation boxes。
Fifty transportation drugs shall use closed cargo transportation tools。
Article 51 Transportation refrigerator、refrigerated cars and car refrigerated boxes of frozen drugs、The insulation box should meet the requirements of temperature control during the drug transport。The refrigerated vehicle has an automatic regulation temperature、Show temperature、Storage and reading temperature monitoring data functions; refrigerated boxes and thermal insulation boxes have the function of the temperature data of external display and collection boxes。
Article 52 Storage、Regular inspections of transportation facilities and equipment、Cleaning and maintenance shall be responsible for a special person，Create records and files。
Section 6 Calibration and Verification
Article 53 Enterprises shall be in accordance with relevant national regulations，For the measuring device、Temperature and humidity monitoring equipment, etc.。
Enterprises should be in the cold storage、Storage and transportation temperature and humidity monitoring system and facilities and equipment such as refrigerated transportation for use before use、Regular verification and suspension time exceeds the verification of the specified time limit。
Article 54 Enterprise shall be based on the relevant verification management system，Forms a verification control file，Including the verification scheme、Report、Evaluation、Degree treatment and prevention measures。
Article 55 The verification shall be implemented in accordance with the pre -determined and approved scheme，Verification report shall be reviewed and approved，Verification files should be archive。
Article 56 Enterprise shall be based on the parameters and conditions determined according to the verification，Cure、Reasonable use of related facilities and equipment。
Section 7 Computer System
Article 57 Enterprises shall establish a computer system that can meet the requirements of the entire process management and quality control requirements，Realize the quality of drugs to traceable，and meet the implementation conditions of drug electronic supervision。
Article 58 The computer system of an enterprise shall meet the following requirements:
(1) Server and terminals with normal operation of supporting systems;
(2) Safety、Stable network environment，There is a fixed access to the Internet and a secure and reliable information platform;
(3)、LANs of information transmission and data sharing between posts;
(4) There are drug business bills generated、Printing and Management Function;
(5) Application software and related databases that meet the requirements of these specifications and the actual needs of enterprise management。
Entry of various types of data、Modify、Save and other operations shall meet the scope of authorization、Requirements for operating regulations and management systems，Guarantee data original、Real、Accurate、Safe and traceability。
Article 60 The data involved in corporate operations and management in the operation of computer system shall be used for security、Reliable ways to store and back up daily，Backup data should be stored in a safe place，The preservation time limit of the recorded data shall meet the requirements of Article 42 of this specification。
Section 8 Purchasing
Article 61 The procurement activities of an enterprise shall meet the following requirements:
(1) Determine the legal qualifications of the supply unit;
(2) Determine the legality of the medicine purchased;
(3) Verify the legal qualifications of the sales staff of the supplier;
(4) Signed a quality assurance agreement with the supplier.
The first camp enterprise involved in the procurement、The first camp variety，The procurement department shall fill in the relevant application form，The review and approval of the person in charge of the quality management department and the person in charge of the enterprise。If necessary, organize field inspections，Evaluate the quality management system of the supply unit。
Article 62 The audit of the first camp enterprise，The following information that is stamped with the original seal of its official seal should be checked，Confirm the true、Effective:
(1) "Drug Production License" or "Drug Business License" copies;
(2) Copy of business license and its annual inspection certificate;
(3) Certificate of Certificate of Quality Management of Drug Production or Copy Certificate of Certificate of Quality Management of Drugs;
(4) Related seal、Make a form (ticket) style with the goods;
(5) Account account name, account bank and account number;
(6) Copy of "Tax Registration Certificate" and "Organization Code Certificate"。
Article 63 The procurement of the first camp should review the legitimacy of the drug，Copy the copy of the drug production or import approval document with the original seal stamped with the official seal of the supplier of the supply unit and review it，Review of it can be purchased without error。
The above information shall be attributed to the drug quality file.
Article 64 Enterprises shall verify、Sales staff of the supplier of the supply unit below:
(1) Copy of the salesperson of the original seal stamped with the official seal of the supply unit;
(2) The original seal stamped with the official seal of the supplier and the license letter of the legal representative seal or signature，The authorized letter should be stated that the name of the authorized person、ID number，and a variety of authorized sales、Region、period limit;
(3) Supply units and related information about supply.
Article 65 The quality assurance agreement signed by an enterprise and the supplier includes at least the following:
(1) Clarify the quality responsibility of both parties;
(2) Suppliers shall provide information that meets the requirements and the authenticity of it、Effectiveness Responsible;
(3) Suppliers shall issue invoices in accordance with national regulations;
(4) Drug quality meets the relevant requirements of drug standards;
(5) Pharmaceutical packaging、Tag、The manual meets the relevant regulations;
(6) The quality assurance and responsibility of drug transportation;
(7) The validity period of the quality assurance protocol.
When purchasing medicines，Enterprises shall ask the supply unit invoice。The invoice should be listed in the common name of the drug、Specification、Unit、quantity、Single price、amount, etc.;，It should be attached to "Sales of goods or provide taxable services"，and stamped with the supplier invoice special seal、Reminder the tax ticket number。
Purchase on the 67th invoice、The name and amount of the sales unit、The name of the product should be with the payment flow and amount、The name of the product is consistent，Corresponding to the content of the financial account。Invoice is stored in accordance with relevant regulations。
Article 68 Purchasing drugs shall establish a procurement record。Procurement records should have a common name for medicines、Dosage form、Specification、Manufacturer、Supplier unit、quantity、Price、Purchase date, etc.，Purchase Chinese medicinal materials、Chinese medicine drinking tablets should also be marked with origin。
Article 69: Disaster situation、Epidemic Love、Special circumstances such as emergencies or clinical emergency treatment，and other situations that meet the relevant regulations of the country，Enterprises can purchase and sell medicines in a direct way，Do not enter the purchased drugs in the warehouse of the enterprise，Send directly from the supply unit to the purchase unit，Create a special procurement record，Guarantee effective quality tracking and traceability。
Article 70 Purchase specially managed medicines，It shall be carried out strictly in accordance with relevant national regulations。
Article 71 Enterprise shall regularly review the overall situation of drug procurement，Establish a drug quality review and supply unit quality file，Perform dynamic tracking management。
Section 9 Received and Acceptance
Article 72 Enterprises shall receive goods on the batches of the drug -arriving drugs in accordance with the prescribed procedures and requirements、Acceptance，Prevent unqualified drugs from entering the library。
Article 73 Drugs when the medicine arrives，The receiving person should verify whether the transportation method meets the requirements，and check the drugs (tickets) and purchase records for check -up drugs，Tickets、Account、Consistent goods。
Traveling with the cargo (ticket) shall include the supply unit、Manufacturer、The common name of the medicine、Dosage form、Specification、Batch number、quantity、The receiving unit、receiving address、Delivery date, etc.，and stamped with the supplier of the supplier's drug outbound special seal。
Article 74 refrigerated、When frozen drugs arrive,，The temperature record of its transportation method and transportation process should be、Transportation time and other quality control conditions for key inspections and records。If it does not meet the temperature requirements, it shall be rejected。
Article 75 of the receiving personnel for the medicine that meets the receipt requirements，It should be placed in the corresponding area of the corresponding check -up area，or set the status logo，Notification acceptance。refrigerated、Frozen drugs should be tested in the cold storage。
Article 76 The acceptance of the drug should check the inspection report of the same batch number in accordance with the drug batch number。Supplier unit is a wholesale enterprise，The inspection report shall be stamped with its quality management special seal。The transfer and preservation of the inspection report can be used in the form of electronic data，But it should be guaranteed to ensure its legitimacy and effectiveness。
Article 77 Enterprises shall be in accordance with the provisions of the acceptance，Sample acceptance for each receiving medicine for each time of delivery，The extraction sample should be representative。
(1) Drugs of the same batch of numbers shall check at least one minimum packaging，But the manufacturer has special quality control requirements or opening the minimum packaging may affect the quality of the medicine，Do not open the minimum packaging;
My stake betting app(stake online sports betting2) Damage、Pollution、osmotic、Block damage and other packaging abnormalities and zero goods、Lakes，Should be checked to the minimum packaging;
(3) outer packaging and sealing a complete raw medicine、Implementation of biological products that are issued and issued and issued，Can not open the box to check。
Article 78 The acceptance personnel shall for the appearance of the sample drugs、Packaging、Tag、Manual and related certification documents, etc.、Checking; after the acceptance is over，Put the extraction sample back to the original packaging box，Seal and mark。
Article 79 Special -managed drugs shall be accepted in the special library or area in accordance with relevant regulations。
Article 80 The acceptance of the acceptance of the acceptance of acceptance records，Including the common name of the medicine、Dosage form、Specification、Approval number、Batch number、Production date、Validity、Manufacturer、Supplier unit、Number of arrival、Date of arrival、Specifications for acceptance、Acceptance results, etc.。Acceptance personnel shall sign the name and acceptance date in the acceptance records。
Records of the acceptance of traditional Chinese medicine should include the name of the product、Place of origin、Supplier unit、Number of arrival、The quantity of the acceptance of acceptance。The acceptance record of Chinese medicine drinking tablets should include the name of the product、Specification、Batch number、Place of origin、Production date、Manufacturer、Supplier unit、Number of arrival、The quantity of the acceptance of acceptance，Traditional Chinese medicine drinking tablets for implementing approval number management shall also record the approval number。
If the acceptance is not qualified, it shall also indicate unqualified matters and disposal measures。
Article 81 Drugs that implement electronic supervision，Enterprises shall scan the code for the electronic supervision code of the drug in accordance with regulations，and upload the data to the China Pharmaceutical Electronic Supervision Network System Platform in time。
Article 82 The enterprise fails to print or paste the Chinese pharmaceutical electronic supervision code in accordance with regulations，or the printing of the regulatory code does not meet the requirements of the requirements，It should be rejected。Regulatory code information does not match the drug packaging information，Inquiry from the supplier in time，Can't enter the library before being confirmed，Report to the local drug supervision and management department if necessary。
Article 83 Enterprises shall establish inventory records，Pharmaceuticals that have passed the acceptance should be registered in time; if the acceptance is not qualified，Can't enter the library，and handled by the quality management department。
Article 84 Enterprise shall perform direct drugs in accordance with Article 69 of these specifications，It can be entrusted to purchase units for drug acceptance。The purchase unit shall be strictly accepted the drugs and the code and data of the drug electronic supervision code in accordance with the requirements of this specification，Establish a special direct drug acceptance record。The relevant information of the acceptance records should be passed to a direct enterprise on the day of acceptance。
Section 10 Storage and Maintenance
Article 85 Enterprises shall reasonably store the medicine according to the quality characteristics of the medicine，and meet the following requirements:
(1) Reserve drugs at the temperature required by the packaging label，There is no specific temperature on the package，Storage in accordance with the storage requirements storage storage storage specified by the Pharmacopoeia of the People's Republic of China;
(2) The relative humidity of storage drugs is 35%to 75%;
(3) Storage of drugs in the warehouse of artificial operations，Practice color standard management according to the quality state: the qualified medicine is green，Unqualified medicines are red，The medicine is to be determined to be yellow;
(4) Storage drugs shall be taken as required as required、Delivery、Ventilation、moisture -proof、Anti -insects、Rat -proof and other measures;
(5) Moving and stacking drugs shall be strictly operated in strict accordance with the requirements of the outer packaging labeling，Stacking height meets the packaging diagram requirements，Avoid damaging the packaging of the medicine;
(6) Pharmaceuticals are stacked by batch number，Different batch numbers must not be mixed，The pitch is not less than 5 cm，and the interior wall of the warehouse、top、Temperature regulation equipment and pipelines and other facilities are not less than 30 cm，The distance from the ground is not less than 10 cm;
(7) Drugs and non -drug、Separation of external drugs and other medicines，Chinese medicinal materials and Chinese medicine decoction tablets in inventory;
(8) Special management medicines shall be stored in accordance with relevant national regulations;
(9) Disassembly of the porn drugs of the outer packaging should be stored centrally;
(Ten) Storing drugs of drugs、pallets and other facilities and equipment should be kept clean，No damage and miscellaneous stacking;
(11) Unrelated personnel shall not enter the storage operating area，Persons in the storage operating area must not have behaviors that affect the quality and safety of the drug;
(12) It is not allowed to store items that are not related to storage management in the pharmaceutical storage operating area。
Article 86 The maintenance personnel shall be based on the condition of the warehouse、external environment、Drug quality characteristics, etc.，The main content is:
(1) Guidance and urging storage personnel to make reasonable storage and operation on the medicine;
(2) Check and improve storage conditions、Protection measures、Sanitary environment;
(3) Effectively monitor the temperature and humidity of the warehouse、Regulatory control;
(4) The appearance of inventory drugs according to the maintenance plan、Packaging and other quality conditions for inspection，Establish a maintenance record; for the storage conditions or varieties with special requirements or a short period of validity, it should be kept in maintenance;
(5) Finding problems should be locked and recorded in the computer system in time，and notify the quality management department for treatment;
(6) The Chinese medicinal materials and Chinese medicine drinks should be maintained and recorded in accordance with their characteristics.，The maintenance methods taken by adopted must not cause pollution to the drug;
(7) Regular summary and analysis of maintenance information.
Article 87 Enterprises shall use a computer system to automatically track and control the validity period of inventory drugs，Adopt measures such as early warning and automatic locking during the validity period，Preventing expired drug sales。
Article 88 Drugs caused liquid due to damage、Gas、When the powder leaks，Should take safety treatment measures quickly，Prevent pollution to the storage environment and other drugs。
Article 89 shall take suspense drugs immediately.，and locked in the computer system，Confirmation of the quality management department at the same time。The following measures should be taken for drugs with quality problems:
(1) Store in a special place with obvious marks，Do not sell;，Do not sell;
(2) Suspecting as a fake medicine，Report the drug supervision and management department in a timely manner;
(3) Drugs belonging to special management，Handling in accordance with relevant national regulations;
(4) The processing process of unqualified drugs should have complete procedures and records;
(5) The reasons should be found and analyzed for unqualified drugs，Time to take preventive measures。
90 Enterprise shall take a regular inventory of inventory drugs，To account、Consistent goods。
Section 11 Sales
91: Enterprise shall sell drugs to legal purchase units，and the certification document of the purchase unit、The identity certificate of the purchaser and the pick -up personnel is verified，Guarantee the flow of drug sales to the real、Legal。
Article 92 Enterprise shall strictly review the production scope of the purchase unit、Scope of business or diagnosis and treatment，and sell drugs in accordance with the corresponding range。
1933 Enterprise Sales Drugs，The invoice should be issued truthfully，Tickets、Account、Stock、Mandarin。
Article 94 Enterprise shall make a good drug sales record。Sales record should include the common name of the medicine、Specification、Dosage form、Batch number、Validity、Manufacturer、Buying unit、Sales quantity、Single price、amount、Sales date and other content。Pharmaceuticals are directly adjusted in accordance with Article 69 of this specification，Dedicated sales records should be established。
The sales record of Chinese medicinal materials should include the name of the product、Specification、Place of origin、Buying unit、Sales quantity、Single price、amount、Sales date and other content; Chinese medicine drinking records should include the name of the product、Specification、Batch number、Place of origin、Manufacturer、Buying unit、Sales quantity、Single price、amount、Sales date and other content。
Article 95 of the drugs that sell special management and drugs with special management requirements，It should be implemented strictly in accordance with relevant national regulations。
Section 12 out of the library
Article 96 When leaving the warehouse, it shall be reviewed with the sales record。Discovery the following situation cannot be obtained，Report the quality management department for treatment:
(1) Damage of drug packaging、Pollution、The seal is not firm、Pads are not true、Seal damage and other problems;
(2) There are abnormal sounds or liquid leakage in the packaging;
(3) Tags fall off、Words are blurred or the content of the logo does not match the real thing;
(4) The medicine has exceeded the validity period;
(5) Other drugs with abnormal conditions.
Article 97 The review of the drug out of the drug shall establish a record，Including purchase units、The common name of the medicine、Dosage form、Specification、quantity、Batch number、Validity、Manufacturer、Date of out of the library、Quality status and reviewers。
Article 98 The special -managed drug outbound shall be reviewed in accordance with relevant regulations。
Article 99 Drug illustrations Shipped the packaging box should have an eye -catching layout logo。
When the 100th medicine is out of the warehouse，It should be attached to the accompanying counter (ticket)。
Enterprises in accordance with Article 69 of this specification，Direct drugs when they are out of the warehouse，Two followers (tickets) of the supplier of the supply unit (ticket)，Send to a direct enterprise and purchase unit。The contents of the same (ticket) with the cargo shall meet the requirements of Article 73, paragraph 2 of this specification，It should also indicate the name of a direct corporate company。
1001 refrigerated、Packing of frozen drugs、Loading and other items，It shall be responsible for and meet the following requirements:
(1) The corresponding temperature requirements should be met before use;
(2) Refrigeration should be completed in a refrigerated environment、Packing of frozen drugs、Boxing work;
(3) Check the start of refrigerated vehicles before loading、Running status，can be installed after reaching the prescribed temperature;
(4) Damage of transportation records should be done when launching，The content includes transportation tools and launch time, etc.。
Article 102 Drugs for implementing electronic supervision，Code and data upload when leaving the warehouse。
Section 13 Transportation and Delivery
Article 103 Enterprises shall be in accordance with the requirements of the quality management system，Strictly implement transportation operation regulations，and take effective measures to ensure the quality and safety of drugs during transportation。
Article 104 Transportation Drugs，It should be based on the packaging of the medicine、Quality characteristics and for car conditions、Road、Weather and other factors，Select the appropriate transportation tool，Take corresponding measures to prevent damage、Pollution and other problems。
When 105 Drugs Drugs，Should check the transportation tool，It is found that the transportation conditions do not meet the requirements，No luck。During the transportation medicine process，Loading tools should be kept confined。
106 Enterprises shall be handled in strict accordance with the requirements of the outer packaging label、Drugs for loading and unloading。
Article 107 Enterprises shall according to the temperature control requirements of the medicine，Take the necessary insulation or refrigeration during transportation、Frozen measures。
During the transportation process，Drugs must not directly contact the ice pack、Ice and other cold storage agents，Preventing affecting the quality of the medicine。
Article 108 in refrigeration、During the transportation of frozen drugs，Should be monitored and recorded in real time、Temperature data in the refrigerated box or insulation box。
Article 109 Enterprises shall formulate refrigeration、emergency plan for freezing drugs，Equipment faults that may occur during transportation、Abnormal weather influence、traffic congestion and other emergencies，Can take corresponding coping measures。
Article 110 The enterprise entrusts other units to transport drugs，Audit the quality guarantee capacity of the transportation party's transportation drugs，Requesting information for transportation vehicles，Only those who meet the conditions and requirements of transportation facilities and equipment in this specification can be commissioned。
Article 111 The commissioned transportation drug commissioned by an enterprise shall sign a transportation agreement with the carrier，Clarify the quality of drug quality、Comply with the transportation operating procedures and the duration of time limit。
Article 112 (112 Enterprise commissioned transportation drugs shall have a record，The quality traceability of the transportation process。Records include at least delivery time、Shipping address、The receiving unit、receiving address、Card number、Number of pharmaceutical parts、Transportation method、Entrusting person、Carrying unit，Those who use vehicle transportation shall also contain the license plate number，Copy the driver's driver's driver's license。Records should be stored for at least 5 years。
Article 133 Drugs that have been loaded shall be carried out and delivered as soon as possible as soon as possible。The commissioned transport，Enterprises shall require and supervise the carrier to strictly perform the entrusted transportation agreement，Prevent the quality of drugs due to the long distance of the road。
Article 114 Enterprises shall take transport safety management measures，Prevent pharmaceutical stealing during transportation、Lost、Replace and other accidents。
The transportation of drugs specially managed stake sports betting appby specially managed drugs My stake betting appshall comply with relevant national regulations。
Section 14 after -sales management
Article 116 Enterprises shall strengthen the management of returns，Make sure the quality and safety of the medicines for the return link，Prevent mixing fake medicine。
Article 117 Enterprises shall be in accordance with the requirements of the quality management system，Development of complaint management operation procedures，The content includes complaint channels and methods、File records、Investigation and evaluation、Processing measures、Feedback and follow -up tracking, etc.。
Article 118 Enterprises shall be equipped with full -time or part -time personnel responsible for after -sales complaint management，Check the reasons for the quality of the complaint，Take effective measures to deal with and feedback in time，and make a record，If necessary。
Article 119 Enterprises shall record information such as complaints and processing results in a timely manner，for query and tracking。
Article 120 Enterprises have found that there are serious quality problems for drugs sold，It should be immediately notified to the purchase unit to be suspended、Recovery and make a record，Report to the drug supervision and management department at the same time。
Article 121 Enterprises shall assist pharmaceutical manufacturers to perform their recall obligations，Deduaded in time according to the requirements of the recall plan、Feedback drug recall information，Control and recover drugs with hidden safety hazards，Create a record of drug recall。
Article 122，Undertaking the monitoring and reporting of adverse reactions in accordance with relevant national regulations。
Chapter 3 Quality Management of Drug Retail
The first section of quality management and responsibilities
Article 123 Enterprises shall formulate quality management documents in accordance with relevant laws and regulations and the requirements of this specification，Carry out quality management activities，Make sure the quality of the medicine。
Article 124 Enterprises shall have business conditions that are compatible with its business scope and scale，Including organizations、Personnel、Facilities and equipment、Quality Management File，and set the computer system in accordance with the regulations。
Article 125，Responsible for the daily management of the enterprise，Responsible for providing the necessary conditions，Ensure that the quality management department and quality management personnel effectively perform their duties，Make sure the enterprise operates drugs in accordance with this specification。
Article 126 Enterprises shall set up a quality management department or equipped with quality managers，Performing the following responsibilities:
(1) Supervise the laws and regulations and specifications of relevant departments and post personnel to implement drug management;
(II) Organization to formulate quality management documents，Guide、The execution of the supervision file;
(3) Responsible for the review of the qualification certificate of the supplier and its sales staff;
(4) Responsible for reviewing the legitimacy of the drugs purchased;
(5) Responsible for the acceptance of drugs，Guidance and supervise drug purchase、Storage、Show、Sales and other links of quality management work;
(6) Responsible for drug quality inquiry and quality information management;
(7) Responsible for the survey of drug quality complaints and quality accidents、Treatment and report;
(8) Responsible for the confirmation and treatment of unqualified drugs;
(9) Responsible for the report of false and inferior drugs;
(10) Report responsible for adverse drug reactions;
(11) Carry out drug quality management education and training;
(12) The review of the operating authority of computer system、Maintenance of basic data of control and quality management;
(13) Responsible for organizing the calibration and verification of organizational equipment;
(14) Guide and supervise pharmacy services;
(15) Others shall be performed by the quality management department or quality management personnel。
Section 2 Personnel Management
Article 127 Enterprises who are engaged in drug management and quality management，The qualification requirements stipulated in relevant laws and regulations and the requirements of these specifications，There must be no relevant laws and regulations to prohibit employment。
Article 128 The legal representative or the person in charge of the enterprise shall have the qualification of a practicing pharmacist。
Enterprises shall be equipped with practicing pharmacists in accordance with relevant national regulations，Responsible for prescription review，Guidance Reasonable medication。
Article 129 Quality Management、Acceptance、Purchasing staff should have pharmacy or medicine、Bio、Chemistry and other related professional academic qualifications or have a Stake Sports Bettingprofessional titles of pharmaceutical professional and technical titles。Quality Management of Chinese Medicine Drinks、Acceptance、Purchasing personnel shall have a education degree or above in the secondary school or above of traditional Chinese medicine or higher in Chinese medicine.。
Sales workers should have the level of high school or above or meet the conditions stipulated by the provincial drug supervision and management department。Traditional Chinese Medicine Drinking Persons should have a Chinese medicine school or above or a Chinese medicine regulator qualification。
Article 130 Enterprise personnel shall accept pre -job training and continuing training of relevant laws and regulations and professional knowledge and skills of medicines and skills，To meet the requirements of this specification。
Article 131 Enterprises shall formulate an annual training plan and carry out training in accordance with the training management system，enable relevant personnel to understand and fulfill their duties correctly。Training should record and establish a file。
Article 132 Enterprises shall sell special medicines for sales、Drugs with special management requirements、Persons with refrigerated drugs receive corresponding training to provide conditions，Make them master relevant laws and regulations and professional knowledge。
Article 133 In the business place，Enterprise staff should wear neat、Sanitary work clothes。
Article 134 Enterprises shall conduct pre -post and annual health checks on those who direct contact with drug positions，Establish a health file。A disease with infectious diseases or other diseases that may pollute drugs，You must not engage in work that directly contacts medicines。
Article 135 in drug storage、Display and other areas that are not allowed to store items and personal products that are not related to business activities，Do not have behaviors that affect the quality and safety of drugs in the working area。
Section 3 file
Article 136 Enterprises shall be in accordance with relevant laws and regulations and these specifications，Formulate quality management documents that meet the actual enterprise。The files include the quality management system、Job Responsibilities、Operation Regulations、File、Records and vouchers，and regular review of quality management documents、Revised in time。
Article 137 Enterprises shall take measures to ensure that the content of the personnel of each position can correctly understand the content of the quality management documents，Effective execution of quality management files。
Article 138 The quality management system of the pharmaceutical retail quality shall include the following content:
(1) Pharmaceutical purchasing、Acceptance、Show、Sales and other links management，Setting the warehouse should also include storage、Maintenance management;
(2) Review of the supplier and procurement varieties;
(3) Management of the sales of prescription drugs;
(4) The management of zero drug disassembly;
(5) Drugs that are specially managed and the management of medicines with special management requirements;
(6) Records and vouchers management;
(7) Collection and query quality information management;
(8) Management of quality accidents and quality complaints;
(9) Chinese Medicine Drinking Prescription Review、Preparation、Checking management;
(10) Management of the validity period of drugs;
(11) Management of Destroyer Destruction of Pharmaceuticals and Drugs;
(12) Regulations on environmental hygiene and personnel health;
(13) Provide medical consultation、Management of pharmacy services such as reasonable medication;
(14) Regulations on the training and assessment of personnel;
(15) Regulations on the report of adverse drug reactions;
(16) Management of computer system;
(17) Regulations on implementing drug electronic supervision;
(18) Others should be specified.
Article 139 Enterprises shall clarify the person in charge of the enterprise、My stake betting appquality Stake Sports Bettingmanagement、Purchasing、Acceptance、Sales staff and prescription review、Responsibilities of deployment and other positions，Setting the warehouse should also include storage、Maintenance and other job responsibilities。
Article 140 Quality Management positions、The responsibilities of the post -review post shall not be performed by other positions。
Article 141 The Retail Operation Regulations shall include:
(1) Pharmaceutical procurement, acceptance, sales;
(2) Prescription review, deployment, and check;
(3) Review, deploy, and check the prescriptions of Chinese medicine decoction tablets;
(4) Demolition and retail sales;
(V) Special management of drugs and nationals with special management requirements for drugs;
(6) Drug display and inspection of business places;
(7) Storage of refrigerated drugs in business places;
(8) Operation and management of computer systems;
(9) Setting the warehouse should also include the operating regulations for storage and maintenance。
Article 142 Enterprises shall establish drug procurement、Acceptance、Sales、Display inspection、temperature and humidity monitoring、Related records such as unqualified drug treatment，Be real、Full、Accurate、Effective and traceable。
Article 143 Records and related vouchers shall be stored for at least 5 years。The records and vouchers of specially managed drugs are stored in accordance with relevant regulations。
Article 144 When the data is recorded through the computer system，Related personnel shall be in accordance with the operating regulations，Log in to the computer system through authorization and password，Entry data，Guarantee data original、Real、Accurate、Safe and traceability。
Article 145 electronic record data shall be safe、Reliable ways to backup regularly。
Section 4 facilities and equipment
Article 146 The business venue of an enterprise shall be with its drug business scope、Adapted business scale，Store with medicine、Office、Life assistance and other areas。
Article 147 shall have corresponding facilities or take other valid measures，Avoid the influence of drugs due to the outdoor environment，and be spacious、Bright、Tian Jie、Sanitary。
Article 148 The following business equipment shall have the following business equipment:
(1) Shelf and counter;
(2) Equipment of monitoring and regulating temperature;
(3) operating Chinese medicine drinking tablets，Equipment with stored slices and prescriptions;
(4) The operation of refrigerated drugs，There are special refrigerated equipment;
(5) Operating the second type of psychiatric medicine、Toxic Chinese medicine varieties and poppy shells，There are special storage equipment that meets the safety requirements;
(6) The deployment tool required for drug disassembly sales、Packaging supplies。
Article 149 Enterprises shall establish a computer system that can meet the requirements of operation and quality management，and meet the implementation conditions of drug electronic supervision。
Article 150，The inner wall of the warehouse should be achieved、Top light，ground flat，The structure of the doors and windows is tight; there is reliable security protection、Anti -theft and other measures。
Article 151 Warehouse shall have the following facilities and equipment:
(1) Effective isolation equipment between drugs and ground;
(2) Avoiding light、Ventilation、moisture -proof、Anti -insects、Rat -proof and other equipment;
(3) Effective monitoring and controlling temperature and humidity equipment;
(4) Lighting equipment that meets the requirements of storage operations;
(5) Special place for acceptance and acceptance;
(6) Special storage places for unqualified drugs;
(7) Operating refrigerated drugs，There is a special equipment that is compatible with its business varieties and business scale。
Article 152 Drugs operating special management shall have a storage facility that meets the state regulations。
Article 153 Storage of Chinese medicine drinking slices shall be established for a dedicated warehouse。
Article 154 Enterprises shall be in accordance with relevant national regulations，For the measuring device、Temperature and humidity monitoring equipment, etc.。
Section 5 Purchase and acceptance
Article 155: Enterprise Purchasing Drugs，It should comply with the relevant provisions of Chapter 8 of this specification。
Article 156 When the medicine arrives,，The receiving staff should be based on the procurement record，Type the cargo (ticket) of the supplier of the supplier to verify the physical object of the drug，Tickets、Account、Consistent goods。
Article 157 Enterprises shall accept the acceptance of drug -to -drug medicines in accordance with the prescribed procedures and requirements，and do a good job of acceptance records in accordance with Article 80 of these specifications。
Samples extracted and drawn should be representative.
Article 158 refrigerated drugs when they arrive，Check in accordance with Article 74 of this specification。
Article 159 The acceptance drugs shall check the drug inspection report in accordance with Article 76 of this specification。
Article 160 Drugs shall be accepted in accordance with relevant regulations。
Article 161 Drugs that pass the acceptance and acceptance shall be put into the warehouse in time or on the shelf，Drugs implemented by electronic supervision，It should also be in accordance with Article 81 of this specification、Article 82 provisions perform code scanning and data upload，Unqualified acceptance，Can't enter the warehouse or on the shelf，Report quality management personnel treatment。
Section 6 show and storage
Article 162 Enterprises shall monitor and regulate the temperature of the business venue，to make the temperature of the business place meet the requirements of normal temperature。
Article 163 Enterprises shall conduct regular health checks，Keep the environment neat。Storage、to make the temperature of the business place meet the requirements of normal temperature，It is not allowed to place items that have nothing to do with sales activities，and take insect -proof、Rat -proof and other measures，Prevent pollution medicine。
Article 164 The display of medicines shall meet the following requirements:
(1) Press the dosage form、Uses and storage requirements Classification display，Set up the target，Category tags are clear、Putting accurate placement;
(2) Drugs are placed in shelves (cabinets)，Putting neat and orderly，Avoid direct sunlight;
(3) Prescription medicine、African prescription drug partition display，and prescription medicine、Special identifier for non -prescription drugs;
(4) The prescription medicine must not be displayed and sold by the optional way;
(5) Putting the external drugs separately from other medicines;
(6) Demolition of reticulous drugs is concentrated in the zero counter or area;
(7) The second type of psychotropic medicine、Toxic Chinese medicine varieties and poppy shells must not be displayed;
(8) Refrigerated drugs are placed in refrigerated equipment，Monitor and record the temperature in accordance with regulations，and ensure that the stored temperature meets the requirements;
(9) The writing of Chinese medicine drinking cabinets should be authentic;，Prevent wrong fight、String; should be cleared regularly，Prevention of Drinking Sets、Mold、Severing quality; Different batches of drinks should be cleared and recorded before fighting;
(10) The operating non -drug should set up a area，Obvious isolation from the drug area，And there is a wake -up target。
Article 165 Enterprises shall regularly display、Store medicines for examination，Key check zero drugs and easy deterioration、Near -effect period、Pharmaceuticals with longer placement time and Chinese medicine tablets。Discovering drugs with quality should be removed in time，Stop sales，confirmed and dealt with by quality management personnel，Keep related records。
Article 166 Enterprises shall track the effective period of drugs，Prevent the expired use that may occur after the drug is sold at the time of near the efficiency。
Article 167，Drug storage and maintenance management of the warehouse shall comply with the relevant provisions of section 10 of this specification Chapter 2。
Section 7 Sales Management
Article 168 Enterprises shall hang the "Drug Business License" at the prominent location of the business venue、Business license、Practitioner pharmacist registration certificate, etc.。
Article 169 The business staff shall wear photos、Name、job cards for posts and other content，is a practicing pharmacist and pharmacy technicians，stake betting appWorking cards should also indicate the qualifications of practice or professional Stake Sports Bettingprofessional titles of pharmacy。The practicing pharmacist who is practicing in the job should be listed clearly。
Article 170 Sales drugs shall meet the following requirements:
(1) The prescription Classic Pharmaceutical Pharmaceutical Pharmacist can be allocated after reviewing;，Prescription with compatible taboos or super doses，It should be rejected，But the prescription physician corrects or signed and confirmed，can be deployed; before the deployment prescription, it can be sold after verification;
(2) Prescription review、Preparation、Checking personnel shall sign or seal on the prescription，and save prescriptions or copies in accordance with relevant regulations;
(3) Drugs for sales should inform customers the validity period;
(4) Selling Chinese medicine tablets can be measured accurately，Inform the decoction method and precautions; provide Chinese medicine drinking tablets for fried service，My stake betting appshall comply with relevant national regulations。
Article 171 Enterprise sales of drugs shall be issued for sales vouchers，The content includes the name of the medicine、Manufacturer、quantity、Price、Batch number、Specifications, etc.，and make a sales record。
Article 172 Demolition and retail sales shall meet the following requirements:
(1) Persons responsible for dismantling and retail have been specially trained;
(II) Remove the workbench and tools to keep clean、Sanitary，Prevent cross -pollution;
(3) Do a good job of disassembling and retail sales，The content includes the start date of zero start、The common name of the medicine、Specification、Batch number、Manufacturer、Validity、Sales quantity、Sales Date、spin -off and review personnel, etc.;
(4) Research and retail sales should be clean、Sanitary packaging，Packaging indicates the name of the drug、Specification、quantity、Usage、Dosage、Batch number、Validity period and pharmacy name and other content;
(5) Provide the original or copy of the drug manual;
(6) During the removal of retail sales，Keep the original packaging and instructions。
Article 173 Drugs that sell specially managed and have special management requirements，Strict implementation of relevant national regulations。
Article 174 Drug advertising propaganda shall strictly implement the regulations on the management of the state's advertising management。
Article 175 Non -employees of the company shall not engage in drug sales related activities in business places。
Article 176 for the implementation of electronic supervision medicines，When selling it，It should be uploaded by code scan and data。
Section 8 after -sales management
Article 177 Except for the reasons for the quality of drugs，Once the medicine is sold，No refundable。
Article 178 Enterprises shall announce the supervision phone of the drug supervision and management department at the business place，Set the customer opinion book，Timely processing customers' complaint on drug quality。
Article 179 Enterprises shall be in accordance with the provisions of the report system of adverse reaction reporting in the country，Collection、Report drug adverse reaction information。
Article 180 Enterprises have found that there are serious quality problems for drugs sold，Should take measures to recover the medicine in time and take records，Report to the drug supervision and management department at the same time。
Article 181 Enterprises shall assist pharmaceutical manufacturers to perform their recall obligations，Control and recover drugs with hidden safety hazards，Create a record of drug recall。
Chapter 4 Affiliation
Article 182 The management of the headquarters of a pharmaceutical retail chain shall comply with the relevant regulations of this specification drug wholesale enterprise，Store management shall comply with the relevant regulations of this specified pharmaceutical retail enterprise。
Article 183 This specification is the basic requirements of the quality management of drug business。Management of Enterprise Informatization、Automatic monitoring of the temperature and humidity of drugs for drug storage、Drug Acceptance Management、Drug Cold Chain Logistics Management、Specific requirements for retail chain management，It is formulated separately by the National Food and Drug Administration in the form of appendix。
Article 184 The meaning of the following terms is:
(1) In -service: The person who determines the labor relationship with the enterprise。
(2) In the job: Responsibilities of the posts stipulated by the personnel during working hours。
(3) First Camp Enterprise: When purchasing medicines，Pharmaceutical production or business enterprises that have a supply and demand relationship with the company for the first time。
(4) The first camp variety: the medicine purchased by this company for the first time。
(5) Original seal: In the purchase and sale activities，In order to prove the corporate seal stamped on related documents or vouchers for the identity of the company、Invoice special chapter、Special chapter for quality management、The original imprint of the special chapter of the drug outbound，Not printing、Photo、Copy and other copied marks。
(6) To be tested:、The drug returned after sale is used in an effective way to isolate or distinguish，The status of the quality acceptance before entering the warehouse。
(Seven) Zero: Refers to dismantling for transportation、Drugs for storage and packaging。
(8) Lakeup delivery: The way to assemble pot drugs to the same packaging box to ship in the same packaging box。
(9) Demolition of retail sales: how to split the minimum packaging and sell sales。
(10) The country has special management requirements: the state's protein assimilation preparation、peptide hormones、Pharmaceuticals with special regulatory measures with special drug compound preparations。
Article 185 Pharmaceutical Purchase of pharmacies and family planning technology service institutions in medical institutions、Storage、Maintenance and other quality management specifications by the State Food and Drug Administration, relevant competent authorities of the State Food and Drug Administration, formulated separately。
The quality management regulations of Internet sales drugs are formulated by the State Food and Drug Administration。
Article 186 Drug operating enterprises violate the specifications，The drug supervision and management department shall be punished in accordance with Article 79 of the Drug Administration Law of the People's Republic of China。
Article 187 This specification will be implemented from June 1, 2013。According to Article 16 of the Drug Administration Law of the People's Republic of China，Specific implementation measures and implementation steps shall be stipulated by the State Food and Drug Administration。
