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[新濠天地线上]Pharmaceutical quality management specification

Date:2015-06-23 10:05 Writer:Weikang Click:
No. ninetieth
"Drug operation quality management standards" have been in November 2012 6 by the Ministry of health executive will be passed, is hereby promulgated, and shall be implemented as of June 1, 2013.
Foreign minister Chen Zhu
January 22, 2013
[新濠天地线上]Pharmaceutical quality management specification
The first chapter is the total
Article 1 to strengthen the pharmaceutical quality management, standardize the behavior of drug operation, ensure safe and effective drug in the human body, in accordance with the pharmaceutical administration law of the people's Republic of China, the pharmaceutical administration law of the people's Republic of China implementation regulations, these rules are formulated.
Article 2 this specification is a set of basic rules for drug management and quality control, the enterprise shall in drug purchase, storage, sale, transportation and other sectors to take effective quality control measures, to ensure the quality of drugs.
Third pharmaceutical trading enterprises shall strictly implement the rules.
Drug production enterprises, in the sale of pharmaceuticals, the process of drug distribution in other involved in the storage and transportation of drugs should also be in line with the requirements of this specification.
Fourth pharmaceutical enterprises should adhere to honesty and trustworthiness, business law. Prohibit any false, fraud.
The second chapter of the quality management of pharmaceutical wholesale
The first section of the quality management system
Article 5. The enterprise shall, according to relevant laws and regulations and the specification of the requirements for the establishment of quality management system determined the quality policy, establishing the quality management system documentation, quality planning, quality control, quality assurance, quality improvement and quality risk management activities.
Article 6 enterprises to develop the quality policy documents should be clear enterprise total quality objectives and requirements, and carried out through the whole process of pharmaceutical trading activities.
Article 7 an enterprise quality management system shall and its business scope and scale of adaptation, including organization, personnel, facilities and equipment, quality management system documents and corresponding computer system.
Eighth enterprises should regularly and key elements of the quality management system change, organize and carry out internal audit.
Article 9 an enterprise should be on internal audit analysis. According to the results, and establish the corresponding quality management system improvement measures, and constantly improve the quality control level, to ensure sustained and effective operation of the quality management system.
The ten enterprises shall adopt prospective or review of the drug distribution process of quality risk assessment, control, communication and review.
Article 11 the enterprise should be the drug supply unit, purchase units of the quality management system for evaluation, confirm the quality assurance ability and reputation for quality, when necessary, carry out on-the-spot investigation.
Twelfth enterprises should be full participation in quality management. Various departments, staff should correctly understand and perform their duties, take the corresponding responsibility for quality. The second section organization and quality management responsibilities
Article 13 an enterprise shall set up its business activities and quality management to adapt to the organization or post, clearly defined the responsibility, authority and the relationship between them.
Article 14 enterprises responsible for the people is the primary responsibility for the quality of medicines, has overall responsibility for the daily management of the company, responsible for the provision of the necessary conditions to ensure quality management and quality management personnel effectively perform their duties, to ensure the enterprises to achieve quality objectives and in accordance with the specification requirements of pharmaceutical trading.
Article 15 the enterprise quality responsible person ought to be held the position of by the senior management personnel, responsible for the overall management of drug quality, carry out their duties independently, in enterprise interior of drug quality management has discretion.
Sixteenth enterprises should set up the quality management department, to effectively carry out the work of quality management. The quality management department shall perform the duties by other departments and personnel.
Seventeenth quality management departments shall perform the following duties:
(a) to urge the relevant departments and personnel to enforce laws and regulations on drug management and the specification;
(two) organize the formulation of the quality management system documentation, guidance, supervision and execution of documents;
(III) responsible for audit to suppliers and purchase units of legitimacy, purchase medicines legitimacy and delivery unit sales personnel, purchase units of the procurement personnel legal qualifications, and according to the changes of the contents of the audit for dynamic management;
(four) quality information collection and management, and the establishment of drug quality archives;
(5) is responsible for the drug's approval, guidance and supervision of drug procurement, storage, maintenance, sales, returns, transportation link quality management work;
(six) responsible for the confirmation of substandard medicines, supervise the implementation process of the unqualified drugs;
(seven) investigation, handling and reporting of drug quality complaints and quality accidents;
(eight) responsible for reports of counterfeit drugs;
(nine) responsible for drug quality query;
(ten) responsible for guiding the quality setting function of computer control system;
(eleven) establish and update the operating authority of computer system audit and quality management of basic data;
(twelve) organize the validation, calibration related facilities and equipment;
(thirteen) responsible for the management of drug recall;
(fourteen) responsible for the reporting of adverse drug reactions;
(fifteen) internal audit and risk assessment of the organization's quality management system;
(sixteen) the organization of drug delivery unit and purchase units, quality management system and quality inspection and evaluation;
(seventeen) the organization of the entrusted transport carrier transportation condition and quality assurance review;
(eighteen) to assist in carrying out quality management education and training;
(nineteen) by the quality management department shall perform other duties.
The third section staff and training
Article 18 enterprises engaged in drug management and quality management personnel shall comply with the requirements of relevant laws and regulations and the rules and regulations of qualification, there shall be no relevant laws and regulations prohibit the employment situation.
Article 19 enterprises responsible person should have a college degree or above the intermediate level professional and technical titles. After the basic professional knowledge of pharmacy training, familiar with the laws and regulations related to the management of drug and the specification.
The person in charge of the article 20 enterprise quality should have bachelor degree or above, licensed pharmacist qualification and more than 3 years pharmaceutical quality management work experience, have quality management ability to correct judgment and ensure the implementation.
Article 21An enterprise quality management departments responsible person should have pharmacist qualification and more than 3 years pharmaceutical quality management work experience, can independently solve the quality problems in the business process.
Twenty-second enterprises should be equipped with the following qualification requirements of the quality management, inspection and maintenance of staff positions with:
(a) engaged in the work of quality management shall have pharmacy school or medical, biological and chemical related major, college education or above the junior professional and technical titles of pharmacy;
(II) engaged in inspection and maintenance work shall have a pharmacy or medical, biological and chemical related professional college or above education or above the junior professional and technical titles of pharmacy;
(III) in Chinese herbal medicine, Chinese medicine Yinpian acceptance shall be with pharmacy of above of professional technical secondary school education or in pharmaceutical intermediate or above professional title; engaged in Chinese herbal medicine, Chinese herbal medicine maintenance work shall be with pharmacy of above of professional technical secondary school education or in a pharmacy in primary above professional technical titles; direct acquisition of property of Chinese herbal medicines, inspection personnel shall have in pharmacy at or above the intermediate level professional and technical titles.
The vaccine business enterprises should also be equipped with two or more professional and technical personnel responsible for the vaccine quality management and inspection work, professional and technical personnel shall be with preventive medicine, medicine, microbiology or medical professional bachelor degree or above the intermediate level professional and technical titles, and have more than 3 years experience in vaccine management or technical work.
The twenty-third is engaged in quality management, inspection personnel should be in-service part-time work, no other business.
Article 24 in procurement personnel shall has a pharmacy or medical, biological and chemical related professional college or above, engaged in the work of the sale, storage and other personnel shall have a culture of high school above degree.
Article 25 enterprises shall be of the posts of their duties and work contents of pre job training and continuing training, to comply with the requirements of this specification.
Article 26 the training content should include the related laws and regulations, pharmaceutical professional knowledge and skills, quality management system, duty and post operation procedures, etc..
Article 27. The enterprise shall, in accordance with the training management system formulate annual training plan and training, so that they can correctly understand and perform their duties. The training shall be documented and set up files.
Article 28 in special management of drugs and refrigerated drug storage, transportation and other working personnel shall accept the relevant laws, regulations, and professional knowledge training and qualified through examination and rear but mount guard.
Article 29 the enterprise shall formulate staff personal hygiene management system, storage, transportation and other personnel dress should comply with labor protection and the preservation of product requirements.
Article 30 the quality management, inspection, maintenance and storage in direct contact with drugs post personnel shall be pre service and annual health check, and the establishment of health records. Suffering from infectious diseases or any other disease which may contaminate the medicine, shall not engage in direct contact with drugs work. Physical condition does not meet the specific requirements of the corresponding positions, shall not engage in related work.
The fourth section of the quality management system documentation
Shall conform to the enterprise actual thirty-first enterprises to develop the quality management system documentation. The file system, including the quality management departments and job responsibilities, procedures, records, reports, documents and records etc..
Article 32 the document drafting, revision, review, approval, distribution, storage, modified, revoked and replaced, such as the destruction of a should be carried out in accordance with the rules of operation for the file management, and keep relevant records.
Thirty-third documents shall be marked with the subject, purpose and document type, number and version number. The text should be accurate, clear, easy to understand.
The file should be classified storage, easy to access.
Article 34 enterprises shall regularly audit, the revised file, the file to use should be for the existing text, have been abolished or invalid file except on file for future reference and shall not appear in the field work.
Article 35. The enterprise shall ensure the positions corresponding to the content of their work necessary documents, and in strict accordance with the provisions of the work.
Thirty-sixth quality management system shall include the following contents:
(a) the provisions of internal audit of quality management system;
(two) the provisions of quality veto;
(three) quality management document management;
(four) the quality information management;
(five) provisions of the supplier, purchase units, delivery unit sales and purchase units procurement personnel qualification;
(six) drug procurement, receipt, inspection, storage, maintenance, sales, warehousing, transportation management;
(seven) the provisions of special management of drugs;
(eight) the validity of drug management;
(nine) substandard drugs, drug destruction management;
(ten) the management of drug return;
(eleven) drug recall management;
(twelve) query quality management;
(thirteen) quality accidents and quality complaints management;
(fourteen) the provisions of ADR report;
(fifteen) the provisions of environmental health, health personnel;
(sixteen) the quality of education, training and examination regulations;
(seventeen) facilities and equipment maintenance and management;
(eighteen) facilities and equipment verification and calibration management;
(nineteen) documents and records management;
(twenty) computer system management;
(twenty-one) the provisions of drug electronic supervision;
(twenty-two) other provisions shall be.
The thirty-seventh departments and job responsibilities shall include:
(a) quality management, procurement, storage, sale, transportation, finance and information management departments;
(II) the people in charge of the enterprise, responsible for the quality and quality management, procurement, storage, sale, transport, finance and information management department is responsible for person's responsibility.
(3) quality management, procurement, delivery, acceptance, storage, maintenance, sales, a library review, transportation, finance, information management responsibilities.
(four) other related responsibilities and drug business.
Article 38 enterprises shall make drug purchasing, receiving, acceptance, storage, maintenance, sales, a library review, transportation and other sectors and computer system operation rules.
Article 39. The enterprise shall establish drug procurement, inspection, maintenance, sales, warehousing review, pin return and purchase of exit, transportation, storage temperature and humidity monitoring, unqualified records related to drug treatment, do true, complete, accurate, effective and can be traced back.
Article 40 the recording data by computer system, relevant personnel shall be in accordance with the rules of operation, through the rear of the authorization and password can be data entry and review; data changes should be the quality management department audit and are done under the supervision of the change process should keep a record of when.
Forty-first written records and certificates shall promptly fill in, and be legible and shall not be arbitrarily altered, shall not be torn up. Change the record, shall indicate the reasons, date and signature, keep the original information legible.
Forty-second records and documents shall be kept for at least 5 years. Record and voucher vaccine, special management of drug storage in accordance with the relevant provisions.
The fifth section of facilities and equipment
Forty-third an enterprise shall have their pharmaceutical business scope, business scope of business premises and warehouse.
Article 44 the warehouse of the location, design, layout, construction, renovation and maintenance shall be in compliance with the drug storage requirements, drugs to prevent pollution, cross contamination, confusion and error.
Article 45 the drug storage operation area, auxiliary operation area and office area and living area separated a certain distance or isolation measures should be.
Article 46 the warehouse scale and conditions shall satisfy the requirements of drug reasonable, safe storage, and reached the following requirements, easy to carry out storage operation:
(a) the warehouse environment clean, no pollution, reservoir or green ground hardening;
(two) in the warehouse wall, the top floor is smooth, smooth, tight doors and windows structure;
(III) warehouse is reliable safety protection measures, to the irrelevant personnel entered the implementation of management control to prevent drug stolen, replace, or mixed with fake;
(four) to prevent outdoor loading and unloading, handling, receiving, shipping and other operations by abnormal weather measures.
Forty-seventh warehouse shall be equipped with the following facilities:
(a) effective isolation between the drug and ground equipment;
(two) light, ventilation, moisture, insects, rodents and other equipment;
(three) effective control of temperature and humidity and indoor air exchange equipment;
(four) automatic monitoring, record the temperature and humidity of equipment;
(five) meet the operational requirements of the lighting equipment store;
(six) for the work area and equipment selection, LCL shipping goods Zero operation and review;
(seven) packaging material storage places;
(eight) special place for acceptance, delivery, return;
(nine) unqualified drugs special storage places;
(ten) business management of special drugs prescribed by the state with storage facilities.
Article 48 business of Chinese herbal medicines, Chinese herbal pieces shall be dedicated warehouse and maintenance work places, direct acquisition of property of Chinese herbal medicines should be set up traditional Chinese medicine sample room (cabinet).
Forty-ninth business, the drug should be refrigerated frozen, equipped with the following facilities:
(a) cold storage and scale and varieties to adapt to the business, the vaccine should be equipped with more than two independent cold storage;
(two) for cold storage automatic temperature monitoring, display, record, control, alarm equipment;
(three) the cold storage refrigeration equipment standby generator or double loop power supply system;
(four) of the special requirements of the drug shall be equipped with low temperature, consistent with its requirements for storage facilities;
(five) refrigerated trucks and refrigerated containers or vehicle insulation boxes and other equipment.
Fiftieth transport drugs shall be used in closed cargo transport.
Article 51 the refrigerated transport, pharmaceutical freeze refrigerated truck and car refrigerator, a heat insulation box shall be in conformity with the drug transport in the process of temperature control requirements. Refrigerated trucks with automatic temperature control and display of temperature, storage and read out the function of temperature monitoring data; storage box, an insulation box with external display and the function of the box body temperature data acquisition.
Article 52 the storage, transportation facilities and equipment regular inspection and cleaning and maintenance shall be by the person in charge, and establish records and archives.
The sixth section calibration and validation
Article 53 Enterprises shall, in accordance with the relevant provisions of the state, of measuring instruments, temperature and humidity monitoring equipment regular calibration or verification.
An enterprise shall use before the validation and periodic verification and withdrawal time exceed the time limit of the validation of cold storage, storage temperature and humidity monitoring system and refrigerated transport and other facilities.
Article 54 Where an enterprise should according to the relevant verification management system, verify the control file, including validation protocol and report, evaluation, deviation handling and preventive measures.
Article 55 validation should be according to previously identified and approved the plan implementation and verification report shall be after review and approval, validation documents should be archived.
Fifty-sixth an enterprise shall according to the parameters and conditions to verify, correct, reasonable use of related facilities and equipment.
Seventh computer system
Article 57 enterprises should be established to meet the business management and quality of the whole process control requirements of the computer system, to achieve the quality of drugs can be traced back, and meet the conditions for implementation of the drug electronic supervision.
The computer system of fifty-eighth enterprises shall comply with the following requirements:
(a) to support the normal operation of the system server and terminal;
(two) a safe, stable network environment, fixed access methods and safe and reliable information platform;
(three) information transmission and data sharing between the post, achieve the Department lan;
(four) a drug business bill generation, print and management functions;
(five) the specification of application software requirements and the actual needs of the enterprise management and the relevant database with.
Article 59 all kings of data entry, modify, save operation should comply with the licensing scope, operation rules and management system, which guarantees that the original data, true, accurate, safe and traceable.
Article 60 computer system operation involves a business and management data shall be adopted for the safe and reliable way of storing and daily backup, backup data should be stored in a safe place, record data preservation time limit shall conform to the requirements of this specification of Article 42.
The eighth section procurement
Sixty-first enterprise procurement activities shall comply with the following requirements:
(a) to determine the supplier's legal qualification;
(two) determine the legitimacy of drug purchase;
(three) verify the delivery unit sales personnel qualification;
(four) quality assurance agreement signed with the supplier.
Procurement relates to the first private enterprises, the first battalion of varieties, purchasing department shall fill in the relevant application form, after quality management department and the enterprise quality responsible person approved. Shall organize investigation when necessary, to evaluate the supplier quality management system.
Article 62 the audit of the first battalion of enterprises shall be inspection stamped with the official seal of the original seal of the following information and confirm the real and effective:
(a) "drug production license" or "drug license" copy;
(two) a copy of business license and annual inspection certificate;
(III) "drug production quality management standards" certification or the GSP certificate photocopy;
(four) the relevant seal, with the goods peer (ticket) style;
(five) the account name, bank account and;
(six) the "tax registration certificate" and "organization code certificate" copy.
Article 63 procurement first camp varieties should be the legitimacy of the drug approval and obtain stamped with the seal delivery unit is the original seal of drug production or import approval certificate copy of the file and will be reviewed, the review and correct the purchase.
The above information should be included in the drug quality archives.
Sixty-fourth, an enterprise shall verify the following information retained supply unit sales staff:
(a) affixed with the seal of the supplier's original seal sales staff ID card copy;
(II) stamped seal delivery unit is the original seal and legal representative of the people seal or signature authorization, authorization shall contain the name, identity card number is authorized, and authorized the sale of varieties, regions and periods.
(three) the supplier and supply varieties of relevant information.
The quality of sixty-fifth enterprises and supply unit signed the guarantee agreement at least include the following contents:
(a) clear responsibility for both quality;
(two) the supplier shall provide in accordance with the provisions of the data and be responsible for the authenticity and validity of;
(three) the supplier shall issue invoices in accordance with state regulations;
(four) the quality of drugs in accordance with relevant requirements of drug standards;
(five) drug packaging, labels and instructions in accordance with the relevant provisions;
(six) to ensure the quality of drug transport and responsibility;
(seven) the term of validity of the quality assurance agreement.
Sixty-sixth procurement of medicines, shall obtain invoices to the supplier of enterprise. The invoice shall column drug generic name, specification, unit, quantity, unit price and amount of money; not all listed shall be attached to the sale of goods or providing taxable services list ", and affix the delivery unit invoice seal the original seal, indicating the number of tax receipt.
Article 67 the invoice purchase, sales unit name and amount, commodity should payment flows and the amount, name the same, and corresponds to the financial accounts of the content. Save the invoice according to the relevant provisions.
Sixty-eighth purchasing drugs shall establish a record of the purchase. Procurement records shall have drug general name, dosage form, specification, manufacturer, delivery unit, quantity, price, purchase date, purchase of Chinese herbal medicines, Chinese herbal pieces should also indicate the origin.
Article 69 the occurrence of a disaster, epidemic or unexpected events or clinical emergency treatment and other special circumstances, and other in accordance with the relevant provisions of the state, enterprises can use straightening way of buying and selling of drugs, the procurement of drugs into the warehouse of the enterprise directly from the supply unit hair sent to purchase units, and the establishment of specialized procurement records and ensure effective quality tracking and tracing.
Seventieth the purchasing management of special drugs, should be strictly in accordance with the relevant provisions of the state.
Article 71 enterprises shall regularly overall situation of drug purchase comprehensive quality assessment, the establishment of drug quality assessment and delivery unit quality files, and dynamic tracking management.
The Ninth Section of receipt and acceptance
Article 72 enterprises shall, in accordance with the prescribed procedures and requirements for the arrival of drug batch of receipt and acceptance, to prevent unqualified drug storage.
Article 73 the arrival of pharmaceuticals, receiving personnel should be verifying whether the mode of transport to meet the requirements, and control together with the goods single tickets and purchase records check drugs, so that the tickets, books, cargo line.
With the goods peer (tickets) shall be including suppliers, manufacturers, drug generic name, dosage form, specification, number, quantity, delivery unit, delivery address, delivery date, content, and affix the delivery drug library dedicated the original seal.
Article 74 refrigeration, freezing the arrival of pharmaceuticals shall be the mode of transport and transport process of recording temperature, time of shipment, quality control of key check and record. Does not meet the temperature requirements should be rejected.
Article 75 received the goods to meet the delivery requirements of the drug, should according to the characteristic varieties of requirements placed on the corresponding quarantine area or set up state flag, the notification of acceptance. Frozen in the refrigerator should be quarantined and drug.
Seventy-sixth drug approval should be in accordance with the same batch of drug batch inspection inspection report. The supplier for the wholesale enterprises, inspection report shall be affixed with the original seal dedicated seal of quality management. The inspection report can take the form of the transfer and preservation of electronic data, but should ensure its legitimacy and effectiveness.
Article 77 enterprises shall be in accordance with the provisions of the approval, on every time the arrival of the drug were by lot acceptance sampling, the sample should be representative.
(a) with a batch of drugs should be checked at least a minimal packaging, but production enterprises have special requirements of quality control or open the minimum package may affect the quality of drugs can not open for minimum packaging;
(II) damage, pollution, permeability fluid, seals damaged packaging abnormalities and zero cargo, LCL should check out of the box to the minimum packaging;
(three) the outer packing and seal integrity of the raw materials, the implementation of biological products issued by the management group, can not check out of the box.
Article 78 inspection personnel shall be of drug sampling appearance, packaging, labels, brochures and related documents one by one check; after the approval, it shall put back the original packing box of extraction of intact samples, sealed and marked.
Seventy-ninth special management of the drug should be in accordance with the relevant provisions of the special warehouse or area acceptance.
Article 80 the drug acceptance shall do a good job in the acceptance of the record, including drug generic name, dosage form, specification and approval document number, batch number, production date, period of validity, manufacturer, delivery units, the number of arrival, arrival date, acceptance number, inspection results and other content. The inspection personnel shall sign the name and date of acceptance in the acceptance record.
Chinese acceptance records should include the name, origin, supplier, delivery quantity, acceptance number etc.. The Chinese herbal medicine inspection records shall include name, size, batch number, place of production, date of production, manufacturers, delivery units, the number of arrival, the acceptance of the quantity, approved the implementation of document management of Chinese herbal medicine also shall record the approval number.
Unqualified acceptance shall also indicate the measures and disposal of unqualified items.
Article 81 on the implementation of electronic monitoring of drug, the enterprise shall in accordance with the provisions of the drug electronic supervision code scan code, and timely upload data to Chinese drug electronic supervision network system platform.
Article 82 Enterprises not in accordance with the provisions of the printed or affixed to the Chinese drug electronic supervision code, or the regulatory code printing does not conform to the specified requirements shall be rejected. Inconsistent regulatory code information and pharmaceutical packaging information shall inquire in time to supply unit, has not been recognized before may not be the warehouse. When necessary to the report of the local pharmaceutical supervisory and administrative departments.
Article 83 enterprises shall establish inventory records and acceptance of the drug should be timely warehousing registration; unqualified acceptance, may not be the warehouse and the quality management department.
Article 84 enterprises according to the provisions of Article 69 of the code of medicines direct transfer of can be entrusted purchase units for drug approval. Purchase units should be strictly in accordance with the requirements of this specification and acceptance of drugs and drug electronic supervision code scan code and data upload, and the establishment of specialized straightening records of drug approval. On the day of acceptance shall be acceptance record relevant information to the direct transfer of enterprises.
The tenth day storage and maintenance
Eighty-fifth enterprises shall rationally according to the drug storage characteristics of drug quality, and meet the following requirements:
(a) temperature according to the package labeling requirements for drug storage, packaging not marked specific temperature, in accordance with the provisions of the Pharmacopoeia of the people's Republic of China the storage requirements for storage;
(two) the drug storage relative humidity is 35% ~ 75%;
(3) in the manual operation of the warehouse storage of medicines, according to the quality state of implementation of color management: qualified drugs for green, substandard drugs for red until determine the drug is yellow.
(four) storage of drugs shall be in accordance with the requirements to avoid light, shading, ventilation, moisture, pest control, prevention measures;
(5) handling and stacking drugs should be strictly packaging labeling requirements specification in the, stacking height in accordance with the requirements for packaging graphic, to avoid the damage of the drug packaging;
(6) drug according to the number of stacking, different batches of the drug shall not mixed pile, pile spacing not less than 5 cm, and the warehouse wall, top, temperature control equipment and pipelines facilities spacing of not less than 30 cm, and ground level spacing of not less than 10 cm;
(seven) drug and non drug, medicine and other medicine separately, Chinese herbal medicine and Chinese herbal medicine storage depots;
(eight) the management of special drugs shall be stored in accordance with relevant state regulations;
(nine) the removal of external packaging goods shall be stored in drug zero;
(ten) the drug storage shelves, pallet and other facilities and equipment should be kept clean, no damage and debris piled up;
(11) is not after the approval of the personnel shall not enter the storage operation, storage within the area of operations personnel shall not act affecting the quality and safety of the drug;
(twelve) the drug storage operation area shall be kept with the storage management of unrelated items.
Article 86 of the maintenance personnel should according to the warehouse conditions and external environment, drug quality characteristics of drug maintenance. The main contents are:
(a) guide and supervise the store personnel to carry out reasonable storage and operation of drugs;
(two) check and improve the storage, protection measures, and health conditions;
(three) for effective monitoring, control of temperature and humidity;
(4) according to the maintenance plan of drug stocks appearance, packaging and other quality status were examined and the establishment of maintenance records; may have of the storage conditions varieties of special requirements or short period of validity shall focus on maintenance;
(5) found that the drug problem should be timely in the computer system locking and logging, and notify the quality management department;
(VI) of traditional Chinese medicine and Chinese herbal medicine should according to the characteristics of efficient methods were adopted to perform maintenance and record and conservation methods taken shall not contaminate the drug;
(seven) regular summary, analysis of maintenance information.
Article 87 enterprises should computer system is used for the drug inventory validity of automatic tracking and control. Take nearly valid early warning and over the validity of automatic locking measures, to prevent the sale of expired drugs.
Article 88 the drugs for damage and lead to leakage of liquid, gas, powder, should quickly take safety measures, to prevent the pollution of storage environment and other drugs.
Article 89 the drugs of questionable quality should be immediately taken to stop the sale of the measures, and the computer system lock, also report to confirm the quality management department. On the quality problems of the drug shall take the following measures:
(a) stored in a special place for obvious signs, and effective isolation, may not be sold;
(two) suspected to be counterfeit, timely reporting of drug supervision and administration department;
(three) belongs to the special management of drugs, in accordance with relevant state regulations;
(four) the process of substandard medicines shall have complete procedures and records;
(five) of substandard drugs should identify and analyze the reasons, to take timely preventive measures.
The ninetieth business should be to stock drugs in regular inventory, do accounts, goods.
Eleventh quarter sales
Article 91 enterprises shall sell drugs to the legitimate purchase units, and the purchase document units, procurement personnel and delivery personnel identity verification, to ensure the authenticity and legality of the drug sales flow.
Article 92 enterprises shall strictly audit purchase units of production scope or range of diagnosis and treatment, and in accordance with the corresponding range of drug sales.
Ninety-third drug sales enterprise shall truthfully, invoices, tickets, accounts, goods, payment agreement.
Ninety-fourth enterprises should do a good job in drug sales records. Sales records shall include drug generic name, specifications, dosage form, batch number, valid, manufacturers, purchase units, sales amount, unit price, total amount, date of sale, etc.. The drugs in accordance with the standard provisions of article sixty-ninth direct transfer, shall establish a special sales record.
Chinese herbal medicine sales records shall include the name, specification, origin, purchase units, sales amount, unit price, total amount, date of sale, etc.; Chinese herbal medicine sales records shall include name, size, batch number, place of origin, manufacturers, purchase units, sales amount, unit price, total amount, date of sale, etc..
Article 95 Where the sales management of special drugs, as well as countries have specialized management requirements of the drugs shall be implemented strictly in accordance with the relevant provisions of the state.
The twelfth section library
Ninety-sixth the library should control sales records for review. The following shall be found out, and report the quality management department:
(a) drug packaging damage, pollution, poor sealing, seal gasket is not real, etc.;
(two) in the package there is abnormal sound or liquid leakage;
(three) the label off, illegible or inconsistent with the physical identification content;
(four) the drug has expired;
(five) other abnormalities of the drug.
Article 97 drug library review shall establish records, including purchase unit, drug generic name, dosage form, specification, quantity, batch number, period of validity, the manufacturer, the date of the Treasury, quality and review personnel.
Ninety-eighth special management of drugs delivery shall be reviewed in accordance with the relevant provisions.
Alternative packaging box ninety-ninth drug delivery LCL should have eye-catching signs of consolidation.
100th drug storehouse, should cover additional enterprise dedicated seal drug out the original seal together with the goods (single ticket).
Enterprises in accordance with the provisions of Article 69 of the code directly modulated drug, straightening drugs out of the library, by the delivery units issued two together with the goods (ticket) respectively, to enterprises and purchase units. With goods peer (ticket) content should conform to the requirements of the specification of the second paragraph of Article 73, should also be marked with the direct transfer of enterprise name.
101st reefer, frozen drug packing, loading and other operations, shall be made by the person responsible for and comply with the following requirements:
(a) car refrigerator or incubator before use shall meet the corresponding requirements of temperature;
(two) shall be completed in refrigerated conditions, frozen refrigerated drug packing, sealing work;
(three) start, running status should be checked for refrigerated vehicles before loading, to reach the required temperature before loading;
(four) the shipment should do transport records, including transport and departure time etc..
The drug 102nd on the implementation of electronic supervision, shall carry out the scan code and data upload in the library.
The thirteenth section transportation and distribution
Article 103 enterprises shall be in accordance with the requirements of the quality management system, strict implementation of the transport operation rules, and take effective measures to ensure the transport process of product quality and safety.
Article 104 of the transport of drugs shall be according to the drugs packaging, quality characteristics and according to the condition, such as road, weather factors, choose suitable means of transport and take the appropriate measures to prevent damage, pollution and other issues.
105th shipment of drugs, shall examine the means of transport, transportation conditions found not in conformity with the provisions, shall not be shipped. In the process of drug transport, vehicles should be kept closed.
106th an enterprise shall, in strict accordance with the requirements of packaging marked handling, loading and unloading of drugs.
Article 107 enterprises shall, according to the requirements of the temperature of the drug control, in the transport process to take the necessary heat preservation and refrigeration, freezing measures.
In the process of transportation, drugs shall not be in direct contact ice, ice and other coolant, to prevent the impact on the quality of drugs.
Article 108 in chilled, frozen drug transit shall be real-time monitoring and recording refrigerated trucks, refrigerated containers or insulation box temperature data.
Article 109, an enterprise shall formulate chilled, frozen drug transport emergency plan, in transit possible equipment failure, abnormal weather, traffic congestion and other emergencies, to take corresponding measures.
Article 110 enterprises entrust other unit of drug transport shall be of carrier transport drug quality assurance ability to audit and obtain transportation vehicle related information, with this specification transport facilities and equipment conditions and requirements of entrusting.
Article 111 the company commissioned by the transport of drugs shall transport agreements with the carrier, clear responsibility for drug quality, abide by the operation regulation of transportation and transit time, etc..
There should be a record of 112nd principal drug transport enterprises, implementation of quality traceability during transportation. Record includes at least the delivery time, delivery address, consignee, delivery address, invoice number, number of drug, means of transport, commissioned by the agency, the carrier unit, the transport vehicles should also be indicated in the license plate number, and retained the driver driving license copy pieces. Records shall be kept for at least 5 years.
The 113rd drugs had been loading shall timely shipment and delivery as soon as possible. Commissioned by the transport, the enterprise shall requirements and monitors the carrier shall strictly fulfill the consignment agreement, to prevent the transit time is too long may affect the drug quality.
Article 114 the enterprise should take transportation safety management measures, prevent the accident of the in transit drug robbery, lost, exchange.
115th special management of drug transport shall comply with the relevant state regulations.
The fourteenth section customer service management
Article 116 enterprises shall strengthen the management to return, the return link drug quality and safety assurance, to prevent the mixing of counterfeit drugs.
Article 117 enterprises should establish a complaint management procedures in accordance with the requirements of the quality management system, including channels for complaints and way, records, investigation and evaluation and treatment measures, feedback and follow up afterwards etc..
Article 118. The enterprise shall be equipped with full-time or part-time personnel responsible for the management of after-sales complaints, complaints of quality problems, identify the reasons, take effective measures timely processing and feedback, and make a record, if necessary should notice delivery unit and pharmaceutical production enterprises.
119th an enterprise shall timely complaints and the handling results and other information in the archives, for querying and tracking.
Article 120 enterprises sold drugs have serious quality problems shall immediately notify the purchase units to stop selling and to recover and make a record, at the same time to the drug supervision and administration department report.
Article 121 enterprises shall assist in drug production enterprises to fulfill the obligation to recall, in accordance with the recall plan timely communication and feedback drug recall information, control and recover the drugs with hidden safety problems, and the establishment of drug recall records.
Article 122 the quality control department of the enterprise shall be equipped with full-time or part-time personnel, in accordance with the relevant provisions of the state bear the adverse drug reaction monitoring and reporting work.
The third chapter of the quality management of pharmaceutical retail
The first section of the quality management and responsibility
Article 123 enterprises shall, in accordance with the relevant laws and regulations and the specification of the requirements of establishing the quality management documents, to carry out quality management activities, to ensure the quality of drugs.
Article 124 enterprise shall have its business scope and scale to adapt to the operating conditions, including organization, personnel, facilities and equipment, quality management, file and in accordance with the provisions of the set of computer system.
Article 125 of the responsible person of the enterprise is the primary responsibility for the quality of medicines, responsible for the daily management of the enterprise, is responsible for providing the necessary conditions to ensure quality management and quality management personnel effectively perform their duties, to ensure that enterprises in accordance with the requirements of this specification drug business.
126th enterprises should set up the quality management department or staff quality management personnel, perform the following duties:
(a) to urge the relevant departments and personnel to enforce laws and regulations on drug management and the specification;
(two) organize the formulation of quality management documents, and guide the supervision, the implementation of document;
(three) responsible for the proof of the supplier and sales personnel qualification examination;
(four) responsible for the procurement of medicines legitimacy audit;
(five) responsible for drug approval, guidance and supervision of drug procurement, storage, display, marketing and other aspects of quality management;
(six) responsible for drug quality and quality management information query;
(seven) investigation, handling and reporting of drug quality complaints and quality accidents;
(eight) responsible for the confirmation of substandard drugs and treatment;
(nine) responsible for reports of counterfeit drugs;
(ten) responsible for the reporting of adverse drug reactions;
(eleven) to carry out drug quality management education and training;
(twelve) maintenance audit, control and quality management of basic data for the operation of the computer system permissions;
(thirteen) the organization responsible for the calibration and measurement instruments;
(fourteen) guidance and supervision of the pharmaceutical service;
(fifteen) shall be made by the quality management department or other quality management personnel to perform the duties.
The second section staff management
Article 127 enterprises engaged in drug management and quality management personnel shall comply with the requirements of relevant laws and regulations and the rules and regulations of qualification, there shall be no relevant laws and regulations prohibit the employment situation.
The person in charge of the legal representative or the enterprises 128th enterprises should have a licensed pharmacist.
In accordance with the relevant provisions of the state enterprises should be equipped with a licensed pharmacist, is responsible for the prescription audit, to guide the rational use of drugs.
Article 129 quality management, inspection, procurement staff shall have pharmacy or medical, biological and chemical related professional education or pharmaceutical professional and technical titles. In Chinese herbal medicine quality management, inspection, procurement staff should have in pharmaceutical technical secondary school degree or above or with medicine specialty in junior college or professional and technical titles.
The salesperson should be in conformity with the provisions of the provincial drug supervision and management departments or more than high school education conditions. Chinese herbal medicine dispensing medicine dispensing with personnel shall have the qualification or above in pharmacy.
Article 130 of the company all staff should receive relevant laws and regulations and medical professional knowledge and skills of pre job training and continuing education, to comply with the requirements of this specification.
Article 131 enterprises shall, in accordance with the training management system formulate annual training plan and training, so that they can correctly understand and perform their duties. The training shall be documented and set up files.
Article 132 enterprises should for sales management of special drugs, countries have a special management requirements of the drug, cold medicines personnel receive appropriate training to provide conditions for the mastery of the relevant laws and regulations and professional knowledge.
133rd in the place of business, enterprise staff should wear clean, sanitary overalls.
Article 134 the enterprise should be to come into direct contact with drugs post pre service and annual health check, and the establishment of health records. Suffering from infectious diseases or any other disease which may contaminate the medicine, shall not engage in direct contact with drugs work.
Article 135 in drug storage and display area shall not be stored and business activities unrelated to the goods and private activities, shall not have behavior affecting the quality and safety of the drug in the work area.
The third section file
Article 136 the enterprises shall, in accordance with relevant laws and regulations and the rules and regulations are formulated in accordance with actual enterprise quality management documents. Documents, including the quality management system, job responsibilities, operating rules, archives, records and documents and other, and the quality management documents regularly reviewed, revised timely.
Article 137 enterprises shall take steps to ensure that the staff a correct understanding of the contents of quality management documents and ensure the effective implementation of the quality management documents.
138th drug retail quality management system shall include the following contents:
(a) drug procurement, inspection, display, sales link management, warehouse settings should also include the storage, maintenance management;
(two) the supplier and procurement audit;
(three) prescription drug sales management;
(four) drug zero management;
(five) the management of special drugs and countries have specialized management requirements for the management of drugs;
(six) documents and records management;
(seven) collect and query quality information management;
(eight) the quality accident, quality complaints management;
(nine) Chinese herbal medicine prescription audit, deployment, check management;
(ten) the validity of drug management;
(eleven) substandard drugs, drug destruction management;
(twelve) the provisions of environmental health, health personnel;
(thirteen) provide medication consultation, to guide the rational use of drugs in pharmacy service management;
(fourteen) the provisions of staff training and assessment;
(fifteen) the provisions of ADR report;
(sixteen) computer system management;
(seventeen) the provisions of drug electronic supervision;
(eighteen) other provisions shall be.
Article 139 enterprises should be clear enterprise responsible, quality management, procurement, inspection, salesperson and prescription audit, such as the deployment of job duties, the Treasury set up should also include storage, maintenance and other responsibilities.
140th quality management positions, prescription audit responsibilities not by other personnel to perform.
141st drug retail operating procedures should include:
(a) drug procurement, acceptance, sales;
(two) check the prescription audit, deployment;
(three) Chinese herbal medicine prescription audit, deployment, check;
(four) drug zero sales;
(five) the management of special drugs and countries have specialized management requirements of drug sales;
(six) business premises drug display and inspection;
(seven) store business premises refrigerated drugs;
(eight) the operation and management of computer system;
(nine) set the warehouse operation rules should also include storage and maintenance.
Article 142 enterprises shall establish a drug procurement, acceptance, sales, display check, temperature and humidity monitoring, unqualified records related to drug treatment, do true, complete, accurate, effective and can be traced back.
143rd records and related documents shall be kept for at least 5 years. Record and voucher management of special drugs kept in accordance with the relevant provisions.
Article 144 through computer system to record data, the relevant personnel shall be in accordance with the rules of operation, through the authorization and password to log on to the computer system, data entry to ensure original data, true, accurate, safe and traceable.
145th electronic record data should be in a safe, reliable way to backup.
The fourth section of facilities and equipment
Article 146 of the enterprise business premises shall be with pharmaceutical business scope and scale of operation to adapt, and drug stores, office, assisted living and other regions separately.
Article 147 business premises shall be with corresponding facilities or take other effective measures and avoid drug products from the influence of outdoor environment, and achieve a spacious, bright, clean and tidy.
148th business premises shall have the following operating equipment:
(a) shelves and counters;
(two) monitoring, temperature control equipment;
(three) management of Chinese herbal medicine, storage pieces and prescription dispensing equipment;
(four) operating cold medicines, special refrigeration equipment;
Operation of the second kind psychotropic substances, toxic varieties of traditional Chinese medicines and poppy shell, comply with the safety rules of special storage facilities;
(six) deployment tools, packaging supplies and drug zero sales required.
Article 149 enterprises should be built to conform to the management and quality management requirements of the computer system, and meet the conditions for implementation of the drug electronic supervision.
Article 150 enterprises set up warehouse, should be done in the warehouse wall, the top finish, ground leveling, door and window structure tight, reliable security protection, security and other measures.
151st warehouse shall have the following facilities:
(a) effective isolation between the drug and ground equipment;
(two) light, ventilation, moisture, insects, rodents and other equipment;
(three) the effective monitoring and control of temperature and humidity equipment;
(four) meet the operational requirements of the lighting equipment store;
(five) acceptance of special places;
(six) unqualified drugs special storage places;
(seven) operating cold medicines, special equipment and operating varieties and scale to adapt.
152nd business management of special drug shall be prescribed by the state in accordance with a storage facility.
153rd storage warehouse shall establish a special Chinese herbal medicine.
Article 154 enterprises shall, in accordance with the relevant provisions of the state, of measuring instruments, temperature and humidity monitoring equipment regular calibration or verification.
The fifth section of procurement and acceptance
155th enterprises purchasing drugs, shall comply with the relevant provisions of the second section of the eighth chapter of this specification.
Article 156 the arrival of pharmaceuticals, receiving personnel shall record in accordance with the procurement, supply unit together with the goods single (ticket) for verification of the drug in kind, so tickets, books, cargo line control.
Article 157 enterprises should comply with the procedures and requirements of the arrival of pharmaceuticals by group of acceptance, and make record of acceptance in accordance with the provisions of Article 80 of the specification of the.
Acceptance of the sample should be representative.
158th cold medicines on arrival, shall be inspected in accordance with the provisions of article seventy-fourth of this specification.
159th drug approval should be in accordance with the provisions of article seventy-sixth of this specification for inspection of pharmaceutical inspection report.
160th special drug management shall conduct acceptance inspection in accordance with the relevant provisions.
The 161 qualified approval of drugs should be timely put in storage or shelf, the implementation of electronic monitoring of drug, should also be in accordance with the provisions in Article 81 and 82 of the specification of scan code and data upload, unqualified acceptance, may not be the warehouse or on the shelves, and reported to the quality management personnel.
The sixth section display and storage
Article 162 of the enterprise should be to monitor and regulate the temperature of the business premises, to the place of business of the temperature to meet the normal requirements.
163rd an enterprise shall conduct regular health checks, to keep the environment clean and tidy. Storage and display pharmaceutical equipment should maintain clean sanitation, shall not be placed has nothing to do with the activities of the sales of goods and take insect pest prevention, rat and other measures, to prevent the contamination of the drug.
Display 164th drugs shall comply with the following requirements:
(a) according to the dosage form, use and storage requirements classification display, and set up eye-catching signs, labels clear handwriting, accurate placement;
(two) the drug is placed on the shelf (cabinet), placed orderly, avoid direct sunlight;
(three) prescription drugs, non prescription drugs and prescription drug partition display, special identification, non prescription drugs;
(four) prescription drugs shall not be used in the way of open optional display and sale;
(five) external medicine and other medicine separated;
(six) zero sales of the drug are stored in zero counters or area;
(seven) second kinds of psychotropic drugs, toxic and poppy varieties of traditional Chinese medicines should be on display;
(VIII) cold medicines placed in refrigerated equipment, in accordance with the provisions of temperature was monitored and recorded, and guarantee the stored temperature to meet the requirements;
(9) of Chinese herbal medicine cabinet bucket spectrum of writing should name the orthography; installed before the fight should check, prevent the wrong bucket, on bucket; should be regular cleaning bucket and prevent pieces worm, moldy, metamorphism, different batches of pieces installed before the fight should cleaning bucket and record;
(ten) non operating drug shall set up a special zone, obvious isolation and drug area, and there are eye-catching signs.
Article 165 enterprises shall periodically check the display and storage of medicines, focus on examination of dismantling zero drugs and easy metamorphism, nearly period of validity, placed a long time medicine and Chinese herbal medicine. Found some questions about the quality of the drug should be promptly removed cabinet, to stop the sale, by quality control personnel recognised and dealt with, and keep the relevant records.
Article 166 enterprises should be the validity of drug tracking and management, to prevent the use of proximity effect of drugs sold may occur after expired.
Article 167 enterprises set up warehouse, warehouse drugs storage and maintenance management should be in accordance with the relevant provisions of this specification in Chapter 2, section 10.
Seventh quarter sales management
Article 168 enterprises shall be a prominent position in the business place hanging a drug business license, business license, licensed pharmacist registration certificate etc..
Article 169 operating personnel shall wear photo, name, job content, work card, is practicing pharmacists and pharmacy technicians, work cards should also indicate the qualification or pharmaceutical professional and technical titles. In the practice of licensed pharmacist should be listed explicitly.
170th sales of pharmaceutical products shall meet the following requirements:
(a) prescription by the licensed pharmacist examination before deployment; prescription listed drugs shall not be arbitrarily changed or substituted, incompatible or over dose prescription, shall refuse to deploy, but the doctor's prescription corrections or re signed, can be deployed; prescription dispensing after your partner may be sold;
(II) prescription audit, deployment, check their shall sign or affix a seal on the prescription, and in accordance with the relevant provisions of the preservation of prescription or a copy of its parts;
(three) sales nearly valid drugs shall be valid to inform customers;
(IV) sales of Chinese herbal pieces do accurate measurement, and inform the decoction method and the matters needing attention; Chinese herbal medicine decoction service, shall comply with the relevant provisions of the state.
Article 171 enterprises, in the sale of pharmaceuticals shall issue sales vouchers, including drug name, manufacturer, quantity, price, batch number, specifications, etc., and make a record of the sale.
172nd drug zero sales shall comply with the following requirements:
(a) responsible for zero sales personnel with specialized training;
(two) clean, demolition work station zero and tools for health, to prevent cross contamination;
(3) do demolition zero sales records, including dismantling zero starting date, drug generic name, size, batch number, manufacturer, period of validity, sales volume, sales date, spin off and check personnel and so on.
(IV) dismantling zero sales should use clean, sanitary packaging, packaging marked drug name, specification, quantity, usage, dosage, batch number, period of validity and the name of the pharmacy etc.;
(five) provide the original or a copy of drug instructions;
(six) during the period of zero sales, retain the original packaging and instructions.
Article 173 the sales management of special drugs and countries have special requirements for the management of the drug, it shall strictly implement the relevant provisions of the state.
174th drug advertisement shall strictly implement the provisions of the relevant national advertising management.
175th non working personnel of the enterprise shall not be engaged in drug sales related activities in the place of business.
The drug 176th on the implementation of electronic supervision, shall be sold in, scan code and data upload to.
The eighth section customer service management
177th in addition to drug quality reasons, the drug once sold, shall not be returned.
Article 178 enterprises shall release of the drug supervision and management department supervision of telephone on the premises, setting up customer opinion book, the timely processing of customer complaints on the quality of pharmaceuticals.
Article 179 enterprises shall, in accordance with the provisions of the relevant national adverse drug reaction reporting system, collect and report information of adverse drug reaction.
Article 180 enterprises sold drugs have serious quality problems, should take timely measures to recover the drug and make a record. And at the same time to the drug supervision and administration department report.
Article 181 enterprises should assist in drug production enterprises to fulfill the obligation to recall, control and recover the drugs with hidden safety problems, and establish the drug recall records.
The fourth chapter is attached
Article 182 of the pharmaceutical retail chain enterprise headquarters management shall comply with the relevant provisions of the standard of pharmaceutical wholesale enterprises, the management of the stores shall comply with the relevant provisions of the standard drug retail enterprises.
183rd this specification for the basic requirements of drug quality management. The specific requirements of enterprise information management, drug storage of temperature and humidity automatic monitoring, approval and management of drugs, pharmaceutical cold chain logistics management, retail management, by the State Food and Drug Administration in Appendix shall be formulated separately.
184th this specification is the meaning of the following terms:
(a) in: and the enterprise labor relations staff determined.
(two): job related personnel to perform their duties at work within the provisions of the post.
(three) the first business: procurement of medicines, pharmaceutical production or operation enterprises for the first time the relationship between supply and demand with the enterprise.
(four) the first camp breed: the procurement of pharmaceutical enterprises for the first time.
(5) the original seal: enterprise in marketing activities, in order to prove the original imprint of corporate identity in the relevant documents or document stamped with the official seal of the enterprise, the special invoice seal, a special seal for quality management, storehouse special chapter, not printing, photocopying, copying, reproduction of the mark.
(VI) quarantine: on returned after the delivery, sales of the drug by effective way isolation or differentiate, in storage before the wait for quality acceptance of the state.
(seven) zero goods: refers to the removed for transport, storage packaging of pharmaceuticals.
(eight) LCL delivery: zero goods assembled to the same drug package delivery way.
(nine) zero sales: the minimum package split sales.
(ten countries have specialized management requirements of the drug: the state of protein assimilation preparations, peptide hormones, containing special medicine compound preparation and other varieties of the implementation of special supervision measures of drug.
Article 185 medical institutions pharmacies and plan family services of drug procurement, storage, and maintenance of quality management specification shall be formulated separately by the State Food and drug supervision and Management Bureau, the relevant departments.
The Internet sales of pharmaceutical quality management regulations formulated by the State Food and drug administration.
Article 186 pharmaceutical trading enterprises in violation of this specification, by the pharmaceutical supervisory and administrative departments in accordance with the provisions of Article 79 of the pharmaceutical administration law of the people's Republic of China shall be punished.
187th this specification shall be implemented as of June 1, 2013. In accordance with the provisions of Article 16 of the pharmaceutical administration law of the people's Republic of China, the specific implementation measures and implementation procedures shall be prescribed by the State Food and drug administration.