"Quality Management Practices for Drug Distribution - Appendix for Quality Management of Drug Retail Distribution (Draft for Comment)" released

The General Department of the State Food and Drug Administration issued an announcement stating that in order to further standardize the behavior of drug retail distribution and ensure the quality and safety of drugs in the retail distribution process, the State Food and Drug Administration organized the drafting of the "Quality Management Practice for Drug Operations-Appendix for Quality Management of Drug Retail Distribution (Draft for Comments)" )", is now open for comments
.
Please fill in the feedback form and send it back to the email address: ypjgs@nmpa.
gov.
cn before March 31, 2022.
Please indicate "Appendix Feedback on Quality Management of Drug Retail Distribution" in the subject of the email
.
Attachments: 1.
Quality Management Practices for Pharmaceutical Distribution—Appendix for Quality Management of Pharmaceutical Retail Distribution (Draft for Comment) Article 1 This appendix applies to the “Quality Management Practice for Pharmaceutical Distribution” (hereinafter referred to as the “Code”), the process of pharmaceutical retailing (including the Quality management of drug distribution behavior involved in online retail)
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Article 2 Drug retail distribution (hereinafter referred to as drug distribution) refers to the selection, review, packaging, sealing, delivery, transportation and other operations of drugs according to the needs of consumers for purchasing drugs, and delivering the drugs to the places designated by consumers and signing for receipt.
logistics activities
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Article 3 Drug retail enterprises shall take effective quality control measures in the process of drug distribution, and meet the requirements of drug informatization traceability, so as to realize the controllable and traceable quality of the whole process of drug distribution
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Article 4 A pharmaceutical retail enterprise shall assign full-time or part-time personnel to be responsible for the quality management of pharmaceutical distribution.
Relevant personnel shall be familiar with the laws and regulations on the management of pharmaceutical distribution, and have the ability to independently and correctly judge and ensure implementation in the quality management of pharmaceutical distribution
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Personnel engaged in the packaging, storage, and distribution of refrigerated and frozen medicines shall, in accordance with the relevant provisions of the Specification, receive relevant laws and regulations and professional knowledge training and pass the examination before they can take up their posts
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Article 5 Drug retail enterprises shall strengthen the management of employees' personal hygiene, conduct annual physical examinations for employees, and shall not engage in drug distribution if they suffer from infectious diseases or other diseases that may contaminate drugs
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Article 6 Drug retail enterprises shall, in accordance with the relevant provisions of the "Specifications", formulate a quality management system for drug distribution, including personnel management, job responsibilities, facilities and equipment, operating procedures, records and vouchers, emergency management, etc.
, and regularly review and revise them in a timely manner
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Article 7 A drug retail enterprise shall establish a management system for the evaluation of drug distribution quality, conduct an internal audit of the quality management operation of the drug distribution link at least once a year, and use the quality problems and opinions collected by the enterprise on a daily basis and fed back in the distribution process as the relevant basis for the evaluation.
, and according to the review results, improve the relevant system documents in a timely manner, train relevant post personnel, and improve the quality management level of drug distribution
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Article 8 In the process of drug distribution, drug retail enterprises shall evaluate and determine the delivery period according to factors such as distance and road conditions; and prepare and select appropriate delivery tools, delivery equipment and packaging according to the business type, scope and delivery time limit
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The distribution process of refrigerated and frozen medicines should strictly abide by the relevant provisions of the "Specifications" to prevent them from breaking out of the cold chain
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Article 9 The use of vehicles for drug distribution shall meet the following conditions: (1) It is a closed type of cargo transportation vehicle; (2) There is an independent area for placing drugs in the carriage, and physical isolation measures are taken to prevent drug contamination and confusion.
(3) Take security measures to prevent drugs from being lost or replaced during the delivery process
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Vehicles dedicated to the distribution of refrigerated and frozen medicines shall meet the requirements of the Specification for refrigerated vehicles
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Article 10 The use of distribution boxes for drug distribution shall meet the following conditions: (1) The box body is made of thermal insulation materials with low water absorption, low air permeability, low thermal conductivity, and good temperature insulation; (2) Non-drugs (medical devices) , except for health food, the same below) and medicines are delivered in a mixed box, the medicine storage area should be physically separated in the box to ensure that medicines and non-drugs are stored separately; (3) Install anti-theft devices to prevent medicines from being lost or replaced during the delivery process
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The distribution boxes for the distribution of refrigerated and frozen medicines shall comply with the requirements of the Specification for incubators (refrigerated boxes)
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Article 11 The packaging and filling materials of the medicines for distribution shall be non-toxic and non-polluting materials to prevent the medicines from being broken or squeezed
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The packaging materials of medicines with temperature, humidity and light-proof requirements should also be packaged with temperature-insulation, moisture-proof and light-proof packaging materials
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Article 12 The materials for making the delivery slip and the delivery package seal shall not be easily damaged; the seal shall bear the words "drug seal", and the ink used for printing information cannot be easily wiped off or the handwriting is illegible
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Once the delivery package has been opened, the package seal should not be able to return to its original state
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Article 13 The distribution equipment shall be regularly inspected, cleaned and maintained, managed by special personnel, and records and files shall be established
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Article 14 Drug retail enterprises shall conduct selection, review, packaging and delivery according to the purchase records of consumers
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If the following conditions are found, the shipment cannot be delivered: (1) The drug packaging is damaged, polluted, the seal is not strong, the liner is not solid, the seal is damaged, etc.
; (2) There is abnormal noise or liquid leakage in the drug packaging; (3) The drug label Falling off, indistinct handwriting, or the content of the label does not match the actual product; (4) The drug has exceeded the validity period or cannot be delivered to consumers within the validity period; (5) Drugs with other abnormal conditions
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Article 15 Drug retail enterprises shall properly package the drugs for distribution, and shall meet the following requirements during operation: (1) The drugs shall be individually packaged and shall not be packaged together with non-drugs; Select suitable packaging materials and filling materials to ensure that the packaging is not easily damaged or deformed during the distribution process, and prevent the drugs in the packaging from being broken or contaminated; Fix the shape, and seal it with a seal at the seal or other appropriate positions; (4) Post a delivery note on the outside of the package
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The information recorded in the delivery and delivery note includes at least the name and contact information of the drug retailer, the name and contact information of the distribution company, and drug storage requirements
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The delivery and delivery note can also be used as a seal; (5) The packaged items are stored in the specially set area to be delivered, and the area to be delivered meets the storage requirements of the delivered medicines
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Article 16 The delivery process shall be operated in accordance with the following requirements: (1) If the delivery box is used for delivery, the drug packages shall be placed in an orderly manner with appropriate space left to avoid damage to the package or seal due to extrusion
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If it is delivered in a box with non-drugs, the package of medicines shall be placed in the special area for medicines in the distribution box; (2) If a delivery vehicle is used for transportation, the packaged piece shall be placed in the medicine area in the carriage
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If the delivery vehicle cannot directly deliver the medicine to the consumers, the delivery enterprise shall continue to choose other suitable delivery tools according to the delivery requirements; (3) There shall be no obvious temperature difference between the frozen food, high-temperature fast food cooked food, etc.
and the storage of the medicine, and there is a hidden danger of pollution (4) During the distribution process, necessary measures shall be taken to avoid external special conditions such as rain, humidity, high temperature, direct sunlight, severe cold, etc.
during the process of packaging, handover, transshipment or transfer.
(5) The distribution of refrigerated and frozen medicines shall also comply with the relevant provisions of the "Specifications"
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Article 17 Drug retail enterprises shall, on the premise of ensuring the quality and safety of drugs, minimize the transit time of delivery
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If it is really necessary to temporarily store during the distribution process, the storage site shall have a storage space suitable for the distribution scale and meet the relevant conditions of the drug storage regulations
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Temporary storage of refrigerated and frozen medicines is prohibited
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Article 18 After the delivery of the medicine, the delivery personnel shall prompt the consumer to confirm the delivery information of the medicine and whether the medicine in the delivery package is damaged or wrong
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When consumers receive medicines, if they find that the delivery packaging is damaged, the seal is damaged, the delivery information does not match, and the medicines in the packaging have quality problems, they have the right to refuse to sign for them, and they can leave certificates through photos, videos,
etc.
Article 19 If a drug is not accepted upon delivery or is returned after sale, it shall be handled in accordance with the following requirements: (1) When the drug is delivered, the delivery package is damaged, the seal is damaged, the delivery information does not match, and the drug in the package is damaged.
If there is a quality problem and the consumer does not sign for receipt, the delivery person shall return it to the drug retail enterprise for processing in accordance with the relevant requirements of the "Specifications"; (2) The drug is signed by the consumer, but the delivery information is found to be inconsistent, or the quality of the drug is found to have problems.
In such circumstances, the drug retail enterprise shall return the product, and the returned drug shall not be further sold
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In other cases, in accordance with the relevant provisions of the "Specification", in principle, no return will be accepted
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Article 20 When a drug retail enterprise entrusts other units to distribute drugs, it shall incorporate its distribution activities into its own drug quality management system to ensure that the entrusted distribution process complies with the requirements of the "Specifications" and this appendix: (1) Check whether the distribution unit has independent The drug distribution quality management agency or the person in charge of quality; (2) Regularly audit the distribution facilities and equipment, personnel capability, quality assurance capability, and risk control capability of the distribution unit; (3) Conduct necessary training and assessment for distribution personnel; (4) ) Sign an entrusted distribution agreement with the distribution unit, clarifying the quality responsibilities of both parties, distribution operation procedures, time limit in transit and handling of drug quality and safety accidents, etc.

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If other units are entrusted to distribute refrigerated or frozen medicines, the distribution unit's refrigerated and frozen distribution facilities and equipment, temperature automatic monitoring systems, etc.
shall also be verified
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Article 21 The third-party platform shall be the unit related to the drug retail distribution where it is stationed, and in accordance with the requirements of drug informatization traceability, provide the conditions for sharing information and data during the drug distribution process as needed
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The third-party platform shall conduct a review of relevant distribution companies at least once a year, and the review content shall at least include distribution equipment and facilities, personnel qualifications, quality management level, risk control capabilities, etc.
, and shall stop cooperation with distribution companies whose review results do not meet the requirements
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Article 22 The meanings of the following terms involved in this appendix are as follows: Packaging refers to the general term for containers, packaging materials and auxiliary materials used in accordance with certain technical methods to protect medicines and facilitate distribution during the distribution process
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Packages refer to the items that need to be delivered, such as medicines, sales documents, etc.
, which have been placed in the packaging, and can be delivered after the shape is fixed, sealed and sealed, and the delivery delivery note is affixed
.
Packaging seal refers to a one-time-use seal on the package to prevent the drug from being contaminated, lost or replaced during the delivery process after the drug is put into the package
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The delivery note refers to the label affixed to the outside of the package that records the delivery information of the drug
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A third-party platform refers to a third-party service platform for drug online retail that guides or recommends delivery services for drug retail companies that have settled on the platform through protocols or data interfaces
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2.
Feedback form Instructions for filling in: 1.
Please fill in the full standard name for the name of the unit that raised the opinion, and please fill in the name for personal feedback
.
Please fill in the contact person and contact information for communication
.
2.
Please fill in the reasons for modification in detail, and attach relevant written materials if necessary
.