The General Department of the State Food and Drug Administration publicly solicits opinions on the "Pharmaceutical Business Quality Management Practice-Drug Retail Distribution Quality Management Appendix (Draft for Solicitation of Comments)"


Release time:

2022-04-11

In order to further standardize the behavior of drug retail distribution and ensure the quality and safety of drugs in retail distribution, the State Food and Drug Administration has organized the drafting of the "Pharmaceutical Business quality Management Standard-Drug Retail Distribution quality Management Appendix (draft for soliciting opinions)" (Annex 1). Please fill in the feedback form (Annex 2) and send it back to the e-mail box before March 31, 2022: ypjgs@nmpa.gov.cn. Please indicate "Feedback on Appendix to Drug Retail Distribution Quality Management" in the subject of the e-mail ".

In order to further standardize the behavior of drug retail distribution and ensure the quality and safety of drugs in retail distribution, the State Food and Drug Administration has organized the drafting of the "Pharmaceutical Business quality Management Standard-Drug Retail Distribution quality Management Appendix (draft for soliciting opinions)" (Annex 1).

Please fill in the feedback form (Annex 2) and send it to email before March 31, 2022:ypjgs@nmpa.gov.cnPlease indicate "feedback on appendix of quality management of drug retail distribution" in the subject of the email ".
  
  Annexes: 1. Pharmaceutical Business Quality Management Practices-Drug Retail Distribution Quality Management Appendix (Draft for Comments)
2. Feedback Form


 

General Division of the State Food and Drug Administration

March 21, 2022

 

Annex 1

 

Pharmaceutical Quality Management Practice-Drug Retail

Distribution Quality Management Appendix

(Exposure Draft)

 

Article 1This appendix is applicable to the "Pharmaceutical Business Quality Management Regulations" (hereinafter referred to as the "Regulations"),Drugs involved in the drug retail process (including online retail)Quality management of distribution behavior.

Article IIDrug retail distribution (hereinafter referred to as drug distribution) refers to the logistics activities in which drugs are selected, reviewed, packaged, sealed, delivered and transported according to the demand of consumers for drug purchase, and drugs are delivered to the place designated by consumers and signed.

Article IIIPharmaceutical retail enterprises should take effective quality control measures in the process of drug distribution, and meet the requirements of drug information traceability, so as to realize the quality control and traceability of the whole process of drug distribution.

Article 4Pharmaceutical retail enterprises shall be equipped with full-time or part-time personnel to be responsible for the quality management of drug distribution, and relevant personnel shall be familiar with the laws and regulations on drug circulation management, and have the ability to independently and correctly judge and guarantee the implementation in the quality management of drug distribution.

Personnel engaged in the packaging, storage and distribution of refrigerated and frozen drugs shall, in accordance with the relevant provisions of the Code, receive training in relevant laws, regulations and professional knowledge and pass the examination before taking up their posts.

Article VPharmaceutical retail enterprises shall strengthen the personal hygiene management of their employees, conduct annual health examinations for their employees, and shall not engage in drug distribution if they suffer from infectious diseases or other diseases that may contaminate drugs.

ARTICLE VIPharmaceutical retail enterprises shall, in accordance with the relevant provisions of the Code, formulate a pharmaceutical distribution quality management system, including personnel management, post responsibilities, facilities and equipment, operating procedures, records and vouchers, emergency management, etc., and regularly review and revise them in a timely manner.

Article VIIDrug retail enterprises shall establish a drug distribution quality review management system, carry out at least one internal audit of the quality management operation of drug distribution links every year, take the quality problems and opinions collected by the enterprise on a daily basis and feedback from the distribution links as the relevant basis for the implementation of the review, and timely improve relevant system documents according to the review results, train relevant post personnel, and improve the quality management level of drug distribution.

Article 8In drugsdistribution process, pharmaceutical retailersThe delivery period should be evaluated and determined according to the distance, road conditions and other factors, and the appropriate distribution tools, distribution equipment and packaging should be equipped and selected according to the type of business, scope and delivery time limit.

The distribution process of refrigerated and frozen drugs shall strictly abide by the relevant provisions of the Code to prevent them from being separated from the cold chain.

Article IXUse of carvehicle carried outThe distribution of drugs shouldThe following conditions are met:

The (I) is a closed means of transport for goods;

There is an independent area for placing drugs in the (II) compartment, and there are physical isolation measures to prevent drug contamination, confusion and errors;

Security measures are (III) in place to prevent medicines from being lost or replaced during distribution.

Vehicles specialized in the distribution of refrigerated and frozen drugs shall meet the requirements of the Code for refrigerated vehicles.

Article XThe use of distribution boxes for drug distribution shallThe following conditions are met:

The (I) box is made of low water absorption, small air permeability, small thermal conductivity and good thermal insulation material;

(II) non-drugs (except medical devices and health food, the same below) are mixed with drugs for delivery, the drug storage area in the box shall be physically isolated to ensure that drugs and non-drugs are stored separately;

(III)Install anti-theft devices to prevent the loss or replacement of medicines during distribution.

Distribution boxes for the distribution of refrigerated and frozen drugs shall comply with the requirements of the Code for heat preservation boxes (refrigerated boxes).

Article 11Distribution of drugsPackaging and Filling MaterialsNon-toxic and non-polluting materials should be selected to avoid crushing or squeezing of drugs. There are temperature and humidity, light and other requirements of the drug packaging should also be selected temperature, moisture-proof, light-proof packaging materials.

Article 12Make delivery orders and distribution packaging.The material of the seal shall not be easily damaged; the seal shall beDrug sealThe ink used to print information is not easily wiped or blurred. After the distribution package is removed, the seal of the package shall not be restored to its original condition.

Article 13The distribution equipment shall be inspected, cleaned and maintained regularly, managed by special personnel, and records and files shall be established.

Article 14Pharmaceutical retail enterprises shall conduct selection, review, packaging and delivery against consumer purchase records. The following conditions shall not be shipped:

(I) drug packaging damage, pollution, sealing is not firm, the liner is not real, seal damage and other issues;

Abnormal noise or liquid leakage in (II) drug packaging;

(III) drug labels fall off, the handwriting is blurred or the identification content is inconsistent with the actual product;

(IV) the drug has exceeded the period of validity or cannot be delivered to the consumer within the period of validity;

Drugs (V) other abnormalities.

Article XVPharmaceutical retail enterprises shall properly pack the distributed drugs and meet the following requirements during operation:

(I) use separate packaging for drugs, and may not be combined with non-drugs;

The (II) selects appropriate packaging and filling materials according to the volume, weight, storage conditions, etc. of the drugs to ensure that the packaging is not easily damaged or deformed during distribution and to prevent the drugs in the packaging from being broken and contaminated;

After the (III) drugs and sales documents are loaded into the packaging, the packaging shall be fixed in shape and sealed with a seal at the sealing place or other appropriate positions;

It is (IV) to post and deliver the distribution slip on the outside of the package. The information recorded in the delivery list shall at least include the name and contact information of the drug retail enterprise, the name and contact information of the distribution enterprise, the storage requirements of the drug, etc..Delivery of delivery orders can also be used as a seal;

(V) packages are stored in a specially set up area to be distributed, which meets the storage requirements of the distributed drugs.

Article 16The distribution process shouldOperate according to the following requirements:

(I)Where the distribution box is used for distribution, the drug packaging shall be placed in an orderly manner and appropriate space shall be reserved to avoid crushing and causing damage to the packaging or seal. In the case of mixed box distribution with non-drugs, the drug packaging shall be placed in the special drug area in the distribution box;

(II)If a distribution vehicle is used for transportation, the package should be placed in the drug area in the compartment. If the distribution vehicle cannot directly distribute drugs to consumers, the distribution enterprise shall continue to choose other appropriate distribution tools in accordance with the distribution requirements;

The (III) shall not be mixed with frozen food, high-temperature fast food cooked food and other products that have obvious temperature difference with drug storage and have potential pollution;

In the process of (IV) and distribution, necessary measures shall be taken to avoid the impact of rain, humidity, high temperature, direct sunlight, severe cold and other special external environments on the way, handover, transfer or storage of packages;

(V) distribution of refrigerated or frozen drugs shall also comply with the relevant provisions of the Code.

Article 17Pharmaceutical retail enterprises shall, on the premise of ensuring the quality and safety of drugs, minimize the time in transit for distribution. If temporary storage is really needed in the process of distribution, the storage place shall have a storage space suitable for the distribution scale and meet the relevant conditions of drug storage regulations. Refrigerated and frozen drugs are prohibited from temporary storage.

Article 18After the drug is delivered, the distribution personnel shall prompt the consumer to confirm the distribution information of the drug and whether the drug in the distribution package is damaged or wrong. When receiving drugs, if consumers find that the distribution package is damaged, the seal is damaged, the distribution information is inconsistent, and there is a quality problem with the drugs in the package, they have the right not to sign for it, and can leave a certificate by means of photos, videos, etc.

Article 19If the drug is not signed at the time of delivery or returned after sale, it shall be handled in accordance with the following requirements:

(I)When the medicine is delivered, becauseIf the distribution package is damaged, the seal is damaged, the distribution information is inconsistent, and the quality of the drugs in the package is not signed by the consumer, the distributor shall return it to the drug retail enterprise for handling in accordance with the relevant requirements of the Code;

(II)If the drug is signed by the consumer, but the distribution information is found to be inconsistent afterwards, or if there is a problem with the quality of the drug, the drug retail enterprise shall return the product, and the returned drug shall not continue to be sold. In other cases, in accordance with the relevant provisions of the "Code", in principle, no return is allowed.

Article 20When a drug retail enterprise entrusts other units to distribute drugs, it shall incorporate its distribution activities into its drug quality management system to ensure that the entrusted distribution process meets the requirements of the Code and this Appendix:

(I) check whether the distribution unit has an independent drug distribution quality management agency or quality person in charge;

(II) regular audits of distribution facilities and equipment, personnel capacity, quality assurance capacity and risk control capacity of distribution units;

(III) necessary training and assessment of distribution personnel;

The (IV) signs an entrusted distribution agreement with the distribution unit to clarify the quality responsibilities of both parties, distribution operation procedures, time limit in transit and the disposal of drug quality and safety accidents.

Where other units are entrusted to distribute refrigerated or frozen drugs, the distribution facilities and equipment of the distribution unit for refrigeration and freezing, and the automatic temperature monitoring system shall also be verified.

Article 21The third-party platform shall provide the conditions for the sharing of relevant information and data in the process of drug distribution in accordance with the requirements of drug information traceability.

The third-party platform shall review the relevant distribution enterprises at least once a year, and the review contents shall at least include distribution equipment and facilities, personnel qualification, quality management level, risk control ability, etc., and the distribution enterprises whose review results do not meet the requirements shall stop cooperation.

Article 22The following terms referred to in this Appendix shall have the meanings:

Packaging refers to the general term for containers, packaging materials and auxiliary materials used in the distribution process to protect drugs and facilitate distribution according to certain technical methods.

Packaging, refers to the drugs, sales documents and other items to be distributed in the packaging, and after the shape is fixed, sealed, affixed to the delivery of the delivery order, can be distributed.

Packaging seal, refers to the drug, etc. into the packaging, in order to prevent the drug in the distribution process of contamination, loss orA closure that is replaced and used once on the package.

A delivery order is a label affixed to the outside of the package that records the drug delivery information.

A third-party platform refers to a drug online retail third-party service platform that guides or recommend distribution services for drug retail enterprises settled in the platform through an agreement or data interface.

 

Annex 2

 

Feedback Form

Unit for putting forward opinions:

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    1.Please fill in the full name of the unit that puts forward the opinions, and please fill in the name of the individual feedback. Please fill in the contact person and contact information for communication.

    2.Please fill in the reasons for the modification in detail, and attach relevant written materials if necessary.