Read the untranslated law here: http://www.chinalaw.gov.cn/article/fgkd/xfg/gwybmgz/201303/20130300385433.shtml
Medicine quality control specifications
(January 22, 2013 the Ministry of Health announced as of June 1, 2013, 90th) Chapter I General provisions
First to improve medicine quality control, standardize drug business, ensure medication is safe and effective, according to the People's Republic of China pharmaceutical administration law and the People's Republic of China pharmaceutical administration law implementing regulations, development of this specification.
The second standard is fundamental to drug management and quality control guidelines, an enterprise shall, in drug procurement, Stockpiling, sale, transport and other sectors to take effective quality control measures, to ensure the quality of drugs.
Article trading enterprises shall strictly implement this specification.
Drug manufacturers sell drugs, others involved in the drug distribution process of storage and transport of drugs, shall conform to the requirements of this specification. Fourth pharmaceutical trading enterprises shall adhere to honesty and trustworthiness, business law.
Against any false, deceptive practices.
Chapter II administration of pharmaceutical wholesale quality management
Section quality management system
Article fifth enterprises shall, in accordance with the relevant laws and regulations and the regulations called for the establishment of quality management system, determine the quality policy, develop the quality management system documentation, quality planning, quality control, quality assurance, quality improvement and quality risk management activities.
Sixth corporate quality policy document should be clear total quality objectives and requirements, and carry out drug operations in the whole process.
Seventh enterprise quality management system should be commensurate with its business scope and scale, including organizational structure, personnel, facilities, equipment, quality management system documents and corresponding computer system.
Eighth enterprise should periodically and when significant changes in the key elements of the quality management system, organizations to carry out internal audits.
Nineth analysis of enterprise internal audit should be carried out, based on the analysis and conclusions to develop the quality management system improvement, and constantly raise the level of quality control to ensure continued effective operation of the quality management system.
Tenth review of the enterprise should be in forward or, on the quality of drug distribution in the process of risk assessment, control, communications, and auditing.
11th Enterprise shall, on drug suppliers to evaluate the quality management system, purchase units, in recognition of their quality assurance and quality reputation, site visits, if necessary. 12th Enterprise shall participate in full quality management.
Departments, staff should correctly understand and carry out their duties, bear the responsibility for the quality of.
Section II organizational and quality management functions
13th article, should be established and its business activities and compatible quality management organizations or jobs, the clear delineation of their responsibilities, authorities and relationships.
14th head of an enterprise is the primary responsibility of pharmaceutical quality, overall responsibility for the daily management of enterprises, and is responsible for providing the necessary conditions, quality assurance management and quality management staff to efficiently carry out their duties to ensure achievement of the quality objectives, and in accordance with the specification requirements for drugs.
15th corporate quality Director should be held by senior management, responsible for drug quality control and independent performance of their functions, in the internal quality control of drugs has the right to rule. 16th Enterprise shall set up a quality control Department, effective quality control.
Duties of the quality control Department shall not be discharged by other departments and personnel.
17th the quality control Department shall perform the following duties:
(A) urge relevant departments and staff to implement drug control laws and regulations and the regulations;
(B) organizations to develop the quality management system documentation, and to guide and oversee implementation of the file;
(C) is responsible for the delivery unit and the legality of purchasing units, purchase medicines legitimacy and supplier sales personnel, purchase the legal qualifications of the procurement staff review and audit content for dynamic management of change;
(Iv) is responsible for the collection and management of quality information, and set up quality files;
(V) the acceptance of drugs, to guide and monitor the drug purchasing, storage, maintenance, sales, returns, and transport and other aspects of quality management;
(Vi) is responsible for the confirmation of substandard drugs, substandard drugs supervises the process;
(G) responsible for drug quality complaint and investigation, treatment of quality accident and reports;
(VIII) is responsible for reports of counterfeit medicines;
(I) is responsible for the quality of drugs inquiry;
(10) is responsible for the instruction set computer system quality control function;
(11) computer system access auditing and quality management establishment and updating of basic data;
(12) verification, calibration-related facilities and equipment;
(13) is responsible for the management of drug recalls;
(14) is responsible for the reporting of adverse drug reactions;
(15) the Organization's quality management system audits and risk assessments;
(16) the Organization of drug suppliers and purchase quality management system and quality inspection and evaluation;
(17) the Organization shall entrust the transport carrier for transportation and quality assurance reviews;
(18) to assist in developing quality education and training;
(19) other duties as shall be carried out by the quality control Department.
Section III, personnel and training
18th enterprise engaged in the drug business and quality management staff, shall comply with the eligibility requirements under relevant laws and regulations and the regulations shall not be banned from working in relevant laws and regulations.
Article 19th business owners should have a junior college degree or above intermediate professional titles, after the basic professional training of pharmacy, familiar with the drug management law and regulations and the regulations.
20th enterprise quality in charge must have a University Bachelor degree, licensed pharmacist qualification and 3 years experience in medicine quality control, quality management work with good judgment and ability to ensure implementation.
21st Enterprise licensed pharmacists in charge of the quality control Department shall have the qualifications and 3 years experience in medicine quality control, able to solve the quality problems in the course of business.
22nd Enterprise shall be equipped with the following eligibility requirements for quality management, inspection and maintenance positions, such as:
(A) engaged in the quality control work, should have a College of pharmacy or medicine, biology, chemistry and other related professional college degree or junior professional titles with pharmacy;
(B) engaged in inspection, maintenance work, should have a pharmacy or medicine, biology, chemistry and other related professional secondary education junior professional titles or pharmacy;
(C) acceptance of Chinese herbal medicine, Chinese herbal medicine, should have traditional Chinese medicine specialized secondary education or with Chinese Materia Medica mid-level professional titles; in Chinese herbal medicine, herbal conservation work, should have traditional Chinese medicine specialized secondary education or with Chinese Materia Medica junior professional titles; direct acquisitions property of Chinese herbal medicines, approval should have Chinese medicine more than mid-level professional titles.
Run vaccine business should also be equipped with 2 or more professional technicians specializing in vaccine quality control and acceptance of professional and technical staff should have a preventive medicine, pharmacy, microbiology or Bachelor degree major in medicine and mid-level professional titles, and have 3 years experience in vaccine management or technical experience.
23rd engaged in quality management, inspection staff should be working on the job, not part-time work.
Article 24th personnel involved in the procurement process should have a pharmacy or medical, biological, chemical and other related background, engaged in marketing, storage and other work should have at least a high school education.
25th enterprise should position their duties and work pre-job training and continuing training to comply with the requirements of this specification.
Article 26th training should include the relevant laws and regulations, pharmaceutical expertise and skills, responsibilities and job procedures, quality management system, and so on. 27th annual training plan of the Enterprise shall, in accordance with the training regulations and training, so that people can understand and carry out their duties.
Training should make records and archives.
28th in the special management of medicines and refrigerated cold remedies, such as storage, transport staff, shall be subject to the relevant laws and regulations and professional knowledge training and pass an evaluation test before they can post.
Article 29th enterprise employees ' personal health management system should be developed, such as storage, transport shall comply with the position of labour protection and preservation requirements. Article 30th quality management, inspection, maintenance, storage direct contacted with drugs, such as the post of personnel shall carry out pre and annual health checks and to establish health records. Suffering from a communicable disease or other diseases might contaminate the drug, may not engage in direct contact with the pharmaceuticals.
Physical condition does not meet the specific requirements of corresponding positions shall not be engaged in related work.
Fourth section quality management system documents 31st enterprise quality management system documentation shall be consistent with the actual article.
Documents including quality management systems, departments and responsibilities, procedures, documents, reports, records and documents.
Article 32nd document drafting, revision, review, approval, distribution, storage, as well as modify, revoke, replace, destruction should be carried out in accordance with the document management procedures, and save the record. Article 33rd documents shall clearly indicate the topic, type, purpose, and number and version number of the file.
Text should be accurate, clear, and easy to understand.
Documents should be classified storage and ease of reference.
34th enterprises shall regularly review and revise documents, using the text file should be in force, repealed or obsolete documents among filed away for future reference, and not at the work site.
35th enterprises shall ensure that all necessary documents corresponding to post their work, and work strictly in accordance with the regulations.
Article 36th quality management system should include the following:
(A) internal audit of quality management system requirements;
(B) the quality provisions of the veto;
(C) management of quality management documents;
(Iv) the quality of information management;
(E) suppliers, purchase units, delivery units sales and unit purchases procurement personnel qualification requirements;
(F) drug procurement, receipt, inspection, storage, maintenance, sales, library, transport management;
(VII) special control provisions of the drug;
(H) management of the drugs period of validity;
(I) management of substandard drugs, drug destruction;
(J) the drug return management;
(11) the management of drug recalls;
(12) the quality management of queries;
(13) quality accidents, complaints about the quality of management;
(14) adverse drug reaction reporting requirements;
(15) the provisions of environmental sanitation and health;
(16) the provisions of quality education and training and assessment;
(17) management of facilities and equipment storage and maintenance;
(18) management of facilities and equipment validation and calibration;
(19) the management of records and documents;
(20) computer system management;
(21) implementation of electronic monitoring of medicines regulations;
(22) other content should provide.
37th sector and job responsibilities include:
(A) quality management, procurement, storage, distribution, transport, finance and information management responsibilities;
(B) heads of the enterprises, in charge of quality and quality management, procurement, storage, distribution, transport, finance and information management responsibilities of Heads of departments;
(C) quality management, procurement, receipt, inspection, storage, maintenance, sales, library review, transportation, finance, information management responsibilities;
(D) other responsibilities associated with the drug.
Article 38th enterprises should develop a drug purchase, receipt, inspection, storage, maintenance, sales, library review, transport links and the operation of the computer system.
39th Enterprise shall set up a drug purchase, acceptance, maintenance, sales, library review, when the PIN is back and buy exit, transport, storage, temperature and humidity monitoring, substandard drugs and other treatment related records, be true, complete, accurate, effective, and can be traced back.
40th through computer systems, data was recorded, the person concerned shall, in accordance with procedures, by means of authorization and password before they can perform data entry or review data changes should be examined by the quality control Department and under the supervision, change process should keep records. 41st written records and documents should be completed in a timely manner, and be legible and shall not be altered, shall not be torn up.
Change the record, you should indicate the reason, date and signature, and keep the same information clearly visible. 42nd records and vouchers shall be retained for at least 5 years.
Vaccines, drugs under special control record and save the voucher in accordance with the relevant provisions.
Facilities and equipment article 43rd fifth section should have with its drug business, business to adapt to the size of business premises and warehouses.
44th warehouse site selection, design, layout, construction, renovation and maintenance should meet the requirements of drug stores to prevent contamination and cross-contamination of the drug, confusion and error.
Article 45th drug store operation area, auxiliary operation area should be separate from the Office area and living area at a distance or isolation measures.
Article 46th warehouse scale and conditions should satisfy the reasonable and safe storage of drugs and meet the following requirements, facilitating storage operations:
(A) the warehouse environment clean, pollution-free, surface hardening, or green;
(B) the warehouse wall, smooth the top, flat on the ground, door and window structures closely;
(C) the warehouse has a reliable safety measures, controlled management of independent access, prevent the drug from being stolen, replaced or mixed with fake;
(D) prevent external loading and unloading, handling, receiving, shipping and other operating measures affected by abnormal weather.
47th warehouse should be equipped with the following facilities:
(A) effective separation between the drug and the ground equipment;
(B) avoid light, ventilation, moisture, insects, mice and other devices;
(C) effective control of indoor and outdoor temperature and humidity and air exchange devices;
(D) monitoring, recording equipment storeroom temperature and humidity;
(E) meet the storage requirements of lighting equipment;
(Vi) for zero chosen, LCL shipment operations and review the work area and equipment;
(G) packaging material storage areas;
(H) the acceptance, delivery, returns, private location;
(I) special storage areas for unqualified drugs;
(J) operating special management of medicines in line with State regulations for the storage facility.
48th engaged in traditional Chinese medicine, Chinese herbal medicine, should have a dedicated Treasury and maintenance of the workplace and direct acquisition of real estate developers should set the sample room for traditional Chinese medicine herbs (Cabinet).
49th operating in refrigeration, cold remedies, should be equipped with the following facilities:
(A) and adapted to its size and variety of cold storage, operating a vaccine cold storage shall be equipped with two or more independent;
(B) for cold temperature automatic monitoring, display, recording, control and alarm devices;
(C) refrigerated equipment stand-by generator sets or double-loop power supply system;
(Iv) drugs with special temperature requirements, shall be equipped with facilities that meet its requirements;
(E) refrigerated vehicles and on-board freezers or incubators and other equipment.
50th transport drugs should be closed cargo transport. 51st transport refrigeration, cold remedies, refrigerated trucks and car cooler, insulated box should meet the requirements of drug transport for temperature control in the process.
Refrigerated trucks with automatic regulation of temperature, temperature, storage and the ability to read the temperature data; refrigerator and incubator with an external display and the function of temperature data in the collection box.
52nd storage, transport facilities and equipment, regular checking, cleaning and maintenance should be undivided, and records and archives.
Sixth section calibration and verification
53rd Enterprise shall, in accordance with the relevant provisions of the State, measuring instruments, temperature and humidity monitoring equipment, such as regular calibration or verification.
Enterprises should be the refrigerator, storage temperature and humidity monitoring system and refrigerated before using facilities such as verification, periodic verification and validation of unavailability in excess of the prescribed time limit.
54th enterprises should be based on authentication management system, forms authentication control file, including verification measures, reporting, evaluation, treatment and prevention of deviations.
55th validation should be predetermined and approved implementation of validation reports should be subject to review and approval, verify that the file should be archived.
56th enterprises should be determined according to the validation parameters and conditions related to correct and rational use of facilities and equipment.
Seventh section computer systems
57th enterprises should be established in accordance with business process management and quality control system, achieving quality dating and meet the conditions of electronic monitoring of medicines.
Article 58th Enterprise computer systems shall meet the following requirements:
(A) support the normal operation of the system's servers and terminals;
(B) secure and stable network environments, have regular access to the Internet and secure information platform;
(C) among the departments, job information and data sharing between local area network;
(D) drug business paper, printing, and management functions;
(E) in line with the norms requirements and actual needs of enterprise software applications and related databases.
Article 59th of various types of data entry, modification, save operations should be consistent with the mandates, operational procedures and requirements of the management system, ensure data is original, authentic, accurate, secure and traceable.
60th computer systems running the businesses involved in the operation and management of data to apply security, reliable storage and backup, backup data should be stored in a safe place, save time of recording such data shall comply with the requirements of specification for 42nd.
Eighth section of the procurement
61st Enterprise procurement activities shall comply with the following requirements:
(A) determine the legal qualification of suppliers;
(B) determine the legitimacy of buying drugs;
(C) verify the legal qualifications of supplier sales personnel;
(D) the quality assurance agreement with the supplier. Enterprises involved in the purchase, the first battalion, the Purchasing Department should fill in the application form, approved by the head of quality management and quality auditing.
When necessary, organize field visits, to evaluate the supplier's quality management system.
62nd article Enterprise audit shall examine with its official seal the original seal of the following information, verify that real, effective:
(A) the pharmaceutical production license or copy of the pharmaceutical business license;
(B) the business license and annual surveillance proof;
(C) of the good manufacturing practices certificate or certified copy of the certificate of the medicine quality control specifications;
(D) the seal, with the goods peer (tickets) style;
(E) Bank name, Bank name and account number;
(Vi) the tax registration certificate and the copy of the certificate of organization code.
63rd purchase first battalion shall examine the legitimacy of drug are sealed by the supplier the original drug production or import copies of approval documents and audit, review correctly before they can purchase.
The above information should be included in drug quality files.
64th Enterprise shall verify, retained the supplier sales people the following information:
(A) the seal supplier sales receipts bearing the original identity card copy;
(B) affix a supplier raw seal and the seal or signature of the legal representative of a power of Attorney, the power of attorney shall set forth the authorized person's name and ID card number and authorized the sale of the varieties, territory and term;
(C) the supplier and supply relevant information.
65th enterprise quality assurance agreement with the supplier at least include the following:
(A) the clear quality of responsibility;
(B) the supplier should be provided in accordance with the information specified in and responsible for their authenticity and validity;
(C) the supply unit shall be invoiced in accordance with State regulations;
(D) drug quality meets pharmaceutical standards and other requirements pertaining to:
(E) the packaging, labels and instructions in accordance with the relevant provisions;
(Vi) transport of drugs quality assurance and liability;
(G) the quality assurance agreement will expire. 66th when purchasing drugs, the Enterprise shall obtain invoice from the supplier.
Invoices shall identify the drug's generic name, specifications, unit, quantity, unit price, amount, and so on; not all listed, shall be attached to the sale of goods or provide taxable services list, and sealed by the Special seal the original supplier invoice, marked tax receipt number. 67th on the invoice to the purchase, sales unit names and amount, name should be consistent with the flow of payments and amount, name, and corresponds to the financial accounts.
Save the invoice in accordance with the relevant provisions. 68th of the procurement of medicines shall establish procurement records.
Purchase record should have the generic name of the drug, dosage form, specifications, manufacturers, unit price, quantity, delivery, purchase date, purchase should also indicate the origin of the Chinese herbal medicine, herbal.
69th disasters, epidemics, accidents or clinical emergency treatment and other special circumstances, as well as other circumstances that comply with relevant regulations of the State, enterprises can be directly modulated way and selling drugs purchased drugs out of this warehouse, sent directly from the supplier to purchase units, and the establishment of a dedicated procurement records, ensuring effective quality tracking and traceability.
70th purchasing drugs under special control, should be carried out in strict accordance with the relevant provisions of the State.
71st enterprises should be carried out regularly on the overall situation of drug purchase comprehensive quality review, establish quality review and supplier quality files, dynamic tracking and management.
Nineth day receipt and acceptance
72nd Enterprise shall, in accordance with the provisions of the procedures and requirements for delivery receipt and acceptance by batches of medicines to prevent unqualified drugs in storage.
73rd drugs on arrival, receiving officers should verify whether the mode of transport to meet the requirements, and control the accompanying peer (tickets) and purchases to check drug, domestic tickets, books, ...
Accompanying peer list (votes) should include suppliers, manufacturers, generic name of the drug, dosage form, specifications, batch number, quantity, receipt, delivery address, delivery date and other information, and with drug supply units out of the seal of the original seal. 74th when chilled, frozen drug delivery, should be on the means of transport and transport of temperature records, transportation time to focus on quality control and record.
Does not meet temperature requirements shall be rejected. 75th receiving officers to meet the requirements of receiving drugs, should be requested by properties in a quarantined area, or state flag is set, notification and acceptance.
Chilled, frozen drugs should be quarantined in the freezer. 76th acceptance of medicines in accordance with drug batch number identification with the batch number of the inspection report. Supplier for wholesale business, inspection report shall bear the quality seal of the original seal.
Inspection report delivery and save electronic forms may be used, but should ensure its legitimacy and effectiveness.
77th Enterprise shall, in accordance with inspection regulations, for each delivery products for lot-by-lot sampling inspection, extraction of samples should be representative.
(A) the drug should check at least a minimum package of the same batch number, production enterprises with special quality control requirements or open a minimum package may affect the quality of medicines, don't open the minimum packaging;
(B) damage, pollution, drainage, wrapping exceptions such as seal damage and zero freight, LCL, should check out of the box to minimize packaging;
(C) the packaging and seal the complete API, implementation of the lot release management of biological products not checked out of the box.
78th approval should be sampled drugs appearance, packaging, labels, manuals and related documentation to examinations, check acceptance after the extracted sound samples should be returned to the original package, sealed and labeled.
79th special management of medicines in accordance with the relevant provisions of article library or acceptance in the area. 80th of the acceptance of the drug shall do a good inspection records, including the generic names of medicines, dosage form, specifications, approval number, batch number, production date, expiry date, manufacturers, suppliers, delivery number, arrival date, the number of acceptance, inspection results, and so on.
Inspection personnel shall sign the record of acceptance acceptance of names and dates. Chinese herbal medicines acceptance record shall include the name, country of origin, supplier number number, delivery, acceptance, and so on.
Herbal acceptance record shall include the name, size, lot number, country of origin, date of production, the number of manufacturers, suppliers, delivery, acceptance number of content, implement the approval, management of herbal or approval number shall be recorded.
Unqualified acceptance of unqualified matters to be indicated and disposal measures.
81st on the implementation of the electronic monitoring of medicines, the Enterprise shall conduct electronic monitoring code scan codes as required, and upload the data to pharmaceutical and electronic supervision network system platform. 82nd provides an enterprise is not printed or affixed to pharmaceutical and electronic monitoring code, or monitoring code printing does not meet the requirements of, and should be rejected.
Monitoring code does not match the information and drug packaging information, inquiries with the supplier shall, without delay, not be confirmed prior to storage, if necessary, report to the local drug regulatory authorities.
83rd Enterprise shall set up inventory record, qualified acceptance shall timely registration of drugs; the unqualified acceptance, shall not be reported as finished, and processed by the quality control Department. Article 84th drug pursuant to specification for the 69th straight tone, commissioned by the unit purchases drugs acceptance. Purchase units should be strictly in accordance with the requirements of this specification acceptance of drugs and conduct electronic monitoring code scan codes and data uploading, and set up special adjustment and acceptance of drug record.
Date of acceptance the acceptance record relevant information should be passed to stir business.
Tenth section storage and maintenance
85th Enterprise shall, in accordance with the quality characteristics to reasonable drug store and meet the following requirements:
(A) the temperature marked by packaging requires stockpiling medicines, specific temperature without the packaging, in accordance with the People's Republic of China Pharmacopoeia storage requirements for storage;
(B) the stockpiling of drugs relative humidity of 35%-75%;
(C) in manual operation of warehouses storing drugs, implementing color management by quality status: eligible drug green, substandard drugs are red, to be determined drug for yellow;
(D) stockpiling medicines should be taken in accordance with the requirements light, shading, ventilation, moisture, insects, mice and other measures;
(V) handling and stacking medicine outer packaging labelling requirements should be strictly in accordance with the instruction, stacking height in accordance with the packaging icon requirements, preventing damage to packaging;
(F) drug by batch number stack, different batches of the drug may not be mixed duo, Duo spaced not less than 5 cm, and warehouse walls, roof, and temperature control equipment and pipeline facilities spaced not less than 30 cm, with floor space of not less than 10 cm;
(VII) drug and non-drug, other drugs for external use and stored separately, Chinese herbal medicine and Chinese herbal medicine store;
(H) the special management of medicines shall be stored in accordance with the relevant provisions;
(IX) remove the external packaging of zero stock medicines should focus on storage;
(J) the storage shelves, trays and other drug equipment shall be kept clean and free of damage and debris piled up;
(11) unauthorised persons shall not enter the storage area, storage operations personnel may not have affected drug quality and Safety Act;
(12) the drug store operations will be allowed in articles not related to storage and storage management.
86th maintenance personnel should be according to warehouse conditions and external environment, the quality characteristics of drug maintenance, the main content is:
(A) to guide and supervise the drug store personnel to be reasonable storage and operations;
(B) review and improve storage conditions, preventive measures, health and the environment;
(C) effective monitoring, the storage temperature and humidity control;
(D) in accordance with the conservation plan to stock medicines appearance, packaging, quality checks, and establishes a record has special requirements for storage or a shorter period should focus on conservation varieties;
(V) found that the drug in question should be locked in the computer systems and records in a timely manner and notify the quality control Department;
(Vi) traditional Chinese medicine and Chinese herbal medicine should be taken according to their characteristics and effective methods of conservation and documentation, the conservation method of drugs shall not be polluted;
(G) summary and analysis maintenance information on a regular basis.
87th business computer systems to automatically inventory validity of the drug should be used to track and control, to take measures such as early warning and expired automatically locks the validity, preventing outdated drugs sales.
Article 88th due to damage caused by liquid, gas, powder leakage, should take prompt security measures prevent pollution to the storage environment and other drugs. 89th of dubious quality should take immediate measures to suspend sales of medicines, and locked in the computer system, while the quality management Department.
On quality problems of drugs should take the following measures:
(A) deposited in the clearly marked private location, and effective quarantine shall be marketed;
(B) suspected of being counterfeit, drug regulatory agency of reports in a timely manner;
(C) the special management of medicines, in accordance with the relevant provisions of the State;
(D) the unqualified drugs and processing process should have a complete set of records;
(E) on the unqualified drugs should identify and analyze the causes and preventive measures in a timely manner.
90th Enterprise stock medicines should be regular inventory, accounts, domestic matches.
11th Festival sales
91st pharmaceutical enterprises shall be sold to legitimate purchases, and purchase documents, procurement and delivery personnel verify the identity to ensure drug sales flow to real, legitimate.
92nd purchase units of production enterprises should be thoroughly examined the scope, scope or range of diagnosis and treatment, and in accordance with the appropriate scope of sales.
93rd enterprise sales, invoiced shall truthfully, tickets, books, cargo, line. 94th enterprises should make drug sales records. Records should include drug generic name, specification, dosage form, batch number, expiry date, manufacturer, purchase units, sales quantity, unit price, amount, date of sale, and more.
Drugs directly modulated in accordance with article 69th in this code, shall establish a dedicated sales records.
Sales records shall include the name, size, origin of Chinese herbal medicines, purchases, sales quantity, unit price, amount, date of sale contents; herbal sales records shall include the name, size, lot number, country of origin, manufacturer, purchase units, sales quantity, unit price, amount, date of sale, and more.
95th selling special management of medicines and medicine of national special management requirements, should be implemented in strict accordance with the relevant provisions of the State.
12th Festival 96th out of the library should be reviewed against the sales records.
Found the following cases shall not be out and report quality control Department:
(A) the packaging appears damaged, contamination, sealing unsound, gaskets, and seals damaged issues;
(B) the packaging there is abnormal sound or liquids;
(C) labels fall off, writing blurred or identify content inconsistent with the physical;
(D) the drug has expired;
(E) other abnormalities of medicines.
97th drug review records should be established, including purchasing unit, drug the generic name, dosage form, specifications, quantity, batch number, expiry date, manufacturers, date, quality and review officers, and so on.
98th special management of medicines shall be reviewed in accordance with the relevant provisions.
99th alternative package for LCL shipments of pharmaceuticals should be eye-catching LCL logo.
Article 100th out of the library, should additional cover drugs from the enterprises with the goods receipts bearing the seal of the original peer list (). Enterprise article 69th straight according to the norms regulating drugs, directly modulated drug library, issued by the supplier of two accompanying peer list (ticket), destined to stir business and purchase units respectively.
Accompanying peer list (votes) should comply with the norms of the 73rd article requirements, should also be marked directly modulated company names.
101th refrigeration, cold remedies, such as packing, loading operation, shall be a responsible and comply with the following requirements:
(A) on-board refrigerator or incubator before using it should reach the temperature required;
(B) should be completed in a refrigerated environment chilled, frozen drug packing and sealing work;
(C) should be checked before loading refrigerated vehicle starting, running, and reach the required temperature before the loading;
(D) shipments should make transport records, including means of transport, and the time of departure.
102th for implementing electronic monitoring of medicines should be swept in the library code and data upload.
13th transportation and distribution 103th Enterprise shall, in accordance with the requirements of the quality management system, strict implementation of the transport operation, and to take effective measures to ensure drug quality and safety in transport.
104th transport medicines, should be based on the drug's packaging, quality characteristics and condition, road, weather and other factors, selecting an appropriate means of transport, take the appropriate measures to prevent damage, pollution and other problems. 105th shipped products, should check that the means of transport, found that conditions do not meet the requirements, shall not be interrupted.
In the course of transporting drugs, their means of delivery should be kept closed.
106th Enterprise outer packaging marking requirements should be strictly in accordance with the transport, loading and unloading drugs.
107th enterprises shall in accordance with temperature control requirements for drugs, in the shipping process to take the necessary measures of insulated or refrigerated, frozen.
During transport, the drug may not be in direct contact with ice packs, ice coolant to prevent impact on the pharmaceutical quality.
108th in chilled, frozen and drug transit, shall monitor and record the refrigerator car, refrigerator or temperature in the incubator data.
Article 109th refrigeration, refrigerated drug transport contingency plans should be developed, may occur during transportation of equipment failure, abnormal weather, traffic congestion and other unexpected events, to take the appropriate measures.
110th enterprises entrust other unit transport drugs, the carrier should be drug quality assurance audit of the capacity of transport to obtain information on transport vehicles, in line with the regulation of transport facilities and equipment conditions and requirements to be a delegate.
111th principal transport medicines transport agreement with the carrier, clear quality responsibilities, compliance practice for transport and in-transit time, and so on. 112th principal transport drugs should be on the record, quality tracking of the transport process. Records include at least the delivery time, shipping address, consignee, receiving address, order number, number of drugs, mode of transport, principal-agent, forwarding, transport shall contain the registration number, and retain copies of driver's license.
Records shall be retained for at least 5 years. 113th has been served drug loading should be shipped in a timely manner as soon as possible.
Commission transport, firms and supervising the carrier should be required strict compliance with principle agreement to prevent the long transit time affect drug quality.
114th transportation safety management enterprises shall take measures preventing transport occur during drug robbery, loss, replacement and other accidents.
115th drugs under special control of transport shall conform to the relevant regulations of the State.
14th day after sales management
116th enterprises shall strengthen the management of returns, guarantees the return aspect of drug quality and safety, prevent mixing counterfeit drugs.
117th Enterprise shall, in accordance with the requirements of the quality management system, develop complaint management procedures, including complaint channels and methods, archival records, survey and assessment, treatment, such as feedback and track.
118th enterprises should be staffed with full-time or part-time personnel responsible for after sales complaints management, identifying causes of quality problems to complaints and take effective measures to deal with and feedback, and make a record and, if necessary, shall notify the supplier and the manufacturer.
119th Enterprise shall promptly complaints and results of information recorded in the archive, in order to query and track.
120th company found drug with serious quality problems have been sold, it shall immediately inform the purchase unit sale, recovery and record and report to the pharmaceutical supervisory and administrative departments.
121th enterprises shall assist the drug manufacturers perform their recall obligations, in accordance with the recall program requires timely communication, feedback and drug recall information, control and retrieval of potentially unsafe drugs, and establish a record of drug recalls.
122th enterprise quality management Department should be staffed with full-time or part-time workers, in accordance with the relevant provisions of the State responsibility for adverse drug reaction monitoring and reporting.
Chapter quality management of pharmaceutical retail
Section quality management and responsibility
123th enterprises shall, in accordance with relevant laws and regulations and requirements of this specification to develop quality management documents, carry out quality control activities, to ensure the quality of drugs.
124th enterprises shall have the scope of its operations and to adapt to the size of the operating conditions, including organizational structure, personnel, facilities, equipment, quality management documents and in accordance with the requirement of a computer system.
125th enterprises is the primary responsibility of pharmaceutical quality, responsible for day-to-day management, is responsible for providing the necessary conditions, quality assurance management and quality management staff to efficiently carry out their duties to ensure that enterprises in accordance with the specification requirements for drugs.
126th Enterprise shall set quality management or quality management staff, shall perform the following duties:
(A) urge relevant departments and staff to implement drug control laws and regulations and the regulations;
(B) organizations to develop quality management documents and guidance, oversee implementation of the file;
(C) is responsible for the supplier and the qualification of the salesperson audits;
(D) is responsible for the procurement of drug legality audit;
(V) the acceptance of drugs, to guide and monitor the drug procurement, storage, display and sales of quality management;
(Vi) is responsible for the quality of pharmaceutical quality enquiries and information management;
(G) responsible for drug quality complaint and investigation, treatment of quality accident and reports;
(VIII) is responsible for the identification of substandard drugs and treatment;
(I) is responsible for reports of counterfeit medicines;
(10) is responsible for the reporting of adverse drug reactions;
(11) drug quality management in education and training;
(12) computer system access auditing, control and quality management of basic data maintenance;
(13) responsible for the calibration and verification of measuring instruments;
(14) to guide and monitor the pharmaceutical services;
(15) should be carried out by the quality assurance or quality management responsibilities.
Section II personnel management
127th personnel working in an enterprise engaged in the drug business and quality management shall meet the eligibility requirements under relevant laws and regulations and the regulations shall not be banned from working in relevant laws and regulations.
128th enterprise legal representative or responsible persons shall meet the qualifications of practicing pharmacists.
Enterprise shall be equipped with a licensed pharmacist in accordance with the relevant provisions, responsible for prescription review to guide rational drug use.
129th quality management, inspection, procurement officers should have a pharmacy or medicine, biology, chemistry and other related professional education or have the pharmacy professional titles.
Chinese herbal medicine quality control, inspection, procurement officers should have Chinese medicine secondary education or with traditional Chinese medicine specialty junior professional titles. A salesperson should have at least a high school education or comply with the conditions prescribed by the provincial drug supervision and Management Department.
Herbal relief personnel should have Chinese medicine secondary education or have Chinese medicine pharmacist qualifications.
Article 130th position shall be subject to the relevant laws and regulations and medical expertise and skills for the job training and continued training to comply with the requirements of this specification. 131th enterprises shall in accordance with the training management system to establish annual training plan and training, so that people can understand and carry out their duties.
Training should make records and archives.
132th enterprises should be selling special management of medicines, countries have special management requirements of pharmaceutical, refrigerated pharmaceutical personnel receive appropriate training to provide the conditions so that their relevant laws and regulations and professional knowledge.
133th open venues, corporate staff should clean and hygienic smock. 134th personnel of the enterprise should be in direct contact with drugs post pre and annual health checks and to establish health records.
Suffering from a communicable disease or other diseases might contaminate the drug, may not engage in direct contact with the pharmaceuticals.
135th in the drug store, the exhibition area shall not store items and personal items not related to operating activities, in work area shall not affect the quality and safety of medicines.
Section III files 136th Enterprise shall, in accordance with the provisions of relevant laws and regulations and the regulations, establish enterprise quality management documents.
Documents including quality management systems, job responsibilities, operating rules, files, records and documents, and file periodic audits of quality management, timely amendments.
137th Enterprise shall take measures to ensure that all staff understand contents of quality management documents, and ensure the effective implementation of quality management documents.
138th of drug retail management system should include the following:
(A) drug procurement, inspection, exhibition, marketing and other aspects of management, set the warehouse should also include storage, conservation management;
(B) the variety of suppliers and procurement audits;
(C) the management of prescription drug sales;
(D) standardizes the management of drugs;
(E) special control medicines and special management requirements of the State Drug Administration;
(F) the management of records and documents;
(G) collection and query the quality of information management;
(H) quality accidents, complaints about the quality of management;
(IX) the management of Chinese herbal medicine prescription audits, deployment, check;
(J) the management of the drugs period of validity;
(11) the management of substandard drugs, drug destruction;
(12) the provisions of environmental sanitation and health;
(13) the medication consultation, guide rational drug use of pharmaceutical care and management;
(14) the provisions of the personnel training and assessment;
(15) adverse drug reaction reporting requirements;
(16) computer system management;
(17) the provisions of implementation of electronic monitoring of medicines;
(18) other content should provide.
139th enterprises shall identify the owner, quality control, purchasing, inspection, sales and prescription approval, deployment of job responsibilities, set the Treasury should also include storage, maintenance and other duties.
140th quality job duties, prescribed audit positions shall not be discharged by others on his behalf.
141th pharmaceutical retail operating procedures should include:
(A) drug procurement, inspection and sales;
(B) the prescription audits, deployment and check;
(C) Chinese herbal medicine prescription audits, deployment and check;
(D) drug standardizes sales;
(E) the special management of medicines and the country has a dedicated pharmaceutical sales management requirements;
(F) the place of display and test of drugs;
(VII) place of storage of refrigerated drugs;
(H) the operation and management of computer systems;
(I) set the Treasury should also include storage and maintenance procedures.
142th Enterprise shall establish a drug purchase, acceptance, sales, display check, temperature and humidity monitoring, substandard drugs and other treatment related records, be true, complete, accurate, effective, and can be traced back. 143th records and related documents shall be kept for at least 5 years.
Special management of records and documents in accordance with the relevant provisions of the drug saved.
144th through computer systems record data, related posts should be in accordance with procedures, by means of authorization and password to log on the computer system, data entry, data original, authenticity, accuracy, security, and traceability.
145th electronic records data should be backed up on a regular basis in a safe, reliable manner.
Fourth section, facilities and equipment
Article 146th place and to adapt to the size of its drug business, management and drug storage, separate Office, life support and other areas.
147th place of business shall have the appropriate facilities or take other effective measures to avoid drugs under the influence of the outdoor environment and spacious, bright, clean and hygienic.
148th place should have the following operating devices:
(A) the shelves and counters;
(B) monitoring, regulating temperature equipment;
(C) the business of herbal, and storage of herbs and prescription dispensing equipment;
(D) the management of refrigerated drugs, have special refrigeration equipment;
(V) management of second kind psychotropic drugs, poisonous varieties of traditional Chinese medicines, and poppy, dedicated storage device that complies with the safety requirements;
(F) drug desired standardizes sales deployment tools and packaging supplies.
149th Enterprise shall set up to meet the requirements of business and quality management systems, and meet the conditions of electronic monitoring of medicines.
150th, enterprise settings to the Treasury, ought to storehouse wall, smooth the top, flat on the ground, door and window structures closely; reliable security protection and anti-theft measures.
151th warehouse shall have the following facilities:
(A) effective separation between the drug and the ground equipment;
(B) avoid light, ventilation, moisture, insects, mice and other devices;
(C) effective monitoring and regulation of temperature and humidity of the equipment;
(D) meet the storage requirements of lighting equipment;
(V) the acceptance of private location;
(Vi) special storage areas for unqualified drugs;
(G) the management of refrigerated drugs, its range and scale of equipment.
Article 152th drugs under special control provisions should be consistent with national storage facility.
Article 153th special warehouse for storage of Chinese herbal medicine should be established.
154th Enterprise shall, in accordance with the relevant provisions of the State, measuring instruments, temperature and humidity monitoring equipment, such as regular calibration or verification.
Fifth section, procurement and acceptance 155th purchasing drugs shall meet the eighth section of the relevant provisions of chapter II of this specification.
Wantong pharmaceutical coverage.
156th drugs arrive, the consignee shall be recorded by the procurement, control supply unit with the goods of the peer list () to verify the drug physical, domestic tickets, books, ...
157th enterprises shall in accordance with the regulations, procedures and requirements for drug acceptance by batches of arrival, and check acceptance records in accordance with this specification section 80th.
Acceptance sampling the sample should be representative.
158th refrigerated drugs on arrival, should be checked in accordance with this specification 74th article.
159th acceptance of medicines in accordance with this standard article 76th inspection report on drug testing.
160th Special management of medicines in accordance with the relevant provisions of article acceptance.
161th acceptance of medicines should be put in storage or shelf, implementing electronic monitoring of drugs, should also be in accordance with this specification 81st, 82nd article scan code and data upload, unqualified acceptance, shall not be put in storage or on the shelves, and quality managers.
Sixth section display and storage
Article 162th place temperature should be monitored and regulated, to place temperature meets the temperature requirements. 163th enterprises shall conduct periodic health checks, keep the environment clean and tidy.
Storage, display the device should be kept clean of drugs and put items regardless of the sales activities and take measures such as pest control, prevention, pollution prevention medicine.
Article 164th displayed shall conform to the following requirements:
(A) according to the preparation, use and store category display and set logo, category labels are clear, placing accurate;
(B) placed on the shelves of medicines (Cabinet), put in good order, avoid direct sunlight;
(C) prescription drugs, non-prescription drugs Division exhibition, and prescription drugs, non-prescription drug special identification;
(D) the prescription of open choice exhibition and sales can not be used;
(E) for external use with other drugs separately;
(Vi) standardizes sales of drug deposited standardizes counters or area;
(G) the second kind psychotropic drugs, poisonous varieties of traditional Chinese medicines, and poppy must not display;
(VIII) placed in refrigeration equipment of refrigerated drugs, to monitor and record the temperature as required, and ensure that the storage temperature is consistent with requirements;
(I) the writing of Chinese herbal medicine cabinet spectrum should justify a positive; loading bucket should be reviewed before, prevent the wrong bucket, bucket; should be clear on a regular basis to prevent pieces insects, mildew, deterioration; different lots of the pieces loaded bucket should be clear and documented before;
(J) the management of non-drugs should be set zone, and pharmaceutical areas in isolation, and logo.
165th enterprises shall regularly check the display and storage of drugs, focus check standardizes perishable drug, peri, placed a long time drug and herbal.
Found that drugs should be withdrawn in a timely manner with quality questions, stop sale, confirmed by the quality manager and handle and keep related records.
166th enterprises should track the validity of drug administration to prevent drugs sold may occur after expiration of the validity.
167th Enterprise warehouse, warehouse drug store management and maintenance shall meet the tenth section of the relevant provisions of chapter II of this specification.
Seventh day sales management
168th Enterprise shall, in place of a significant position in the drug business license, business license, the licensed pharmacist registered card. 169th personnel should wear has photos, names, posts and other content are licensed pharmacists and pharmacy technicians, work shall be indicated in the licensing or pharmacy professional titles.
Practicing licensed pharmacists on duty should be listed explicitly.
170th sales of medicines shall conform to the following requirements:
(A) the prescription by the pharmacist review before the deployment to the prescription drugs listed shall alter or substitute, the incompatibility or overdose of prescription, refuse to deploy, but signed by the prescribing physician to correct or to confirm, deployment prescription dispensing can be checked after sales;
(B) the prescription review, dispensing and checking personnel should hold one in the prescription, and save the copy of the prescription or the in accordance with the relevant provisions;
(C) selling drugs should tell patrons the validity validity;
(D) sales of herbal accurate measurement, and inform the decoction methods and precautions offering herbal and frying service, shall comply with the relevant provisions of the State.
171th enterprises sold medicines should issue sales receipts, including drug name, manufacturer, lot number, quantity, price, specification, and sales records.
Article 172th standardizes sales of medicines shall meet the following requirements:
(A) responsible for standardizes sales through specialized training;
(B) standardizes the Workbench and tools clean, sanitary, and prevent cross contamination;
(C) standardizes sales records, including standardizes the starting date, the drug's generic name, specifications, lot number, manufacturer, date of expiry, sales quantity, date of sale, spin-offs and review personnel;
(D) standardizes sales should use clean and hygienic packaging, the packaging indicated the drug name, specification, quantity, usage name, quantity, batch number, expiry date, as well as pharmacies and so on;
(E) provide medicines originals or photocopies;
(Vi) standardizes sales period, keep the original packaging and instructions.
173th selling special management of medicines and special management requirements of the State of medicine shall strictly implement relevant regulations of the State.
174th pharmaceutical advertising should strictly implement the State regulations on advertising.
175th non-incumbents of the Enterprise shall not be engaged in activities related to drug sales in the business premises.
176th on the implementation of the electronic monitoring of drugs sold, should scan code and data upload.
Eighth day after sales management
177th in addition to pharmaceutical quality reasons, drugs sold may not be returned.
178th enterprises should be announced in place of drug supervision and management departments of supervision, set the customers guestbook, handling complaints from customers on the quality of drugs in a timely manner.
179th enterprises shall, in accordance with the relevant provisions of the adverse drug reaction reporting system, collection, reporting adverse drug reaction information.
180th enterprises found have sold drugs with serious quality problems, shall promptly take measures to recover drugs and record and report to the pharmaceutical supervisory and administrative departments.
181th enterprises shall assist the drug manufacturers perform their recall obligations, control and retrieval of potentially unsafe drugs, and establish a record of drug recalls.
The fourth chapter by-laws
182th headquarters management of pharmaceutical retail chain enterprises should conform to the relevant provisions regulating pharmaceutical wholesale enterprises, store management relevant provisions should comply with the norms of medicine retail enterprises. 183th standard for basic medicine quality control requirements.
On enterprise information management, the storage temperature and humidity automatic monitoring and drug inspection management, pharmaceutical cold chain logistics management, retail chain management and other specific requirements formulated by the State food and Drug Administration Appendix separately.
184th standard the following terms mean:
(A) job: head counts of determining labor and enterprise.
(B) post: related posts within the prescribed job duties during working hours.
(C) the first enterprise: purchasing products, and the enterprise supply and demand of drugs producing or trading enterprises for the first time.
(D) first camp: the first procurement of medicines.
(E) the original seal: purchase and sale activities of enterprises, in order to prove identity documents or documents stamped with the company seal, special nationwide invoice stamp, quality management seal, medicines used for the original mark, cannot be printed, photocopied, copy after copy of the mark.
(F) the quarantine: the delivery, after-sales back drugs to use effective ways to isolate or distinguish, in front of the warehouse waiting for the acceptance of State.
(VII) zero goods: removed for transport, storage and packaging of drugs.
(VIII) LCL shipments: 0 pharmaceuticals Assembly to the same container shipment way.
(IX) standardizes sales: splitting the minimum package sales approach.
(J) the State has a dedicated pharmaceutical management requirements: State of protein assimilation preparations and peptide hormones, including special variety special regulatory measures such as drug compound drugs.
185th medical institutions, pharmacies and family planning technical service institutions drug procurement, storage, conservation and other quality control by the State food and drug administration authorities shall be formulated separately.
Internet sales of medicine quality requirements shall be separately formulated by the State food and drug administration.
186th drug-handling enterprise in violation of this specification, by the pharmaceutical supervisory and administrative department in accordance with the People's Republic of China pharmaceutical management law provides for punishment of the 79th. 187th standard come into force on June 1, 2013. In accordance with the People's Republic of China 16th article of the pharmaceutical administration law, specific implementation measures and procedures prescribed by the State food and drug administration.
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