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Good management practices for drug sales: quality management of drug retail distribution

 Last Update: 2023-01-01
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In order to strengthen the supervision and management of drug sales, further standardize the retail distribution of drugs, and ensure the quality and safety of drugs in the retail distribution process, in accordance with the Measures for the Supervision and Administration of Drug Online Sales and the Good Management Practices for Drug Sales, the State Food and Drug Administration has organized and formulated the Appendix 6 of the Good Management Practices for Drug Sales: Quality Management of Drug Retail Distribution, which is hereby promulgated and will come into force on January 1
, 2023.

This is hereby announced
.

Annex: Appendix 6 of the Good Management Practice for Drug Sales: Quality Management of Drug Retail Distribution

State Food and Drug Administration

November 30, 2022

annex

Good management practices for pharmaceutical business

Appendix 6: Quality Management of Pharmaceutical Retail Distribution

Article 1 This Appendix applies to the quality management
of drug distribution behaviors involved in the drug retail process (including online retail) in the Good Management Practice for Drug Trading (hereinafter referred to as the "Specification").

Article 2: Drug retail distribution (hereinafter referred to as drug distribution) refers to logistics activities
in which drugs are sorted, reviewed, packaged, sealed, shipped, and transported according to consumers' needs for drug purchase, and drugs are delivered to consumers' designated locations and signed for receipt.

Article 3: Pharmaceutical retail enterprises shall employ effective quality control measures in the process of drug distribution, and meet the requirements for traceability of drug informatization, so as to realize controllable and traceable
quality throughout the entire process of drug distribution.

Article 4: Pharmaceutical retail enterprises shall allocate 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 related to the management of drug circulation, and have the ability
to independently and correctly judge and ensure implementation in the quality management of drug distribution.

Personnel engaged in the distribution of refrigerated and frozen drugs shall also receive training in relevant laws and regulations and professional knowledge in accordance with the relevant provisions of the Specification, and pass the assessment before they can take up their posts
.

Article 5 Pharmaceutical retail enterprises shall strengthen the management of employees' personal hygiene and conduct annual health examinations
for employees.

Article 6: Pharmaceutical retail enterprises shall, in accordance with the relevant provisions of the Norms, formulate a quality management system for drug distribution, including personnel management, job responsibilities, facilities and equipment, operating procedures, records and vouchers, emergency management, and other such content, and periodically review and promptly revise
them.

Article 7: Pharmaceutical retail enterprises shall establish a quality review and management system for drug distribution, carry out an internal audit of the operation of quality management in the drug distribution link at least once a year, take the quality problems and opinions feedback from the daily collection and distribution of the enterprise as the relevant basis for the implementation of the review, and promptly improve relevant system documents according to the review results, train personnel in relevant positions, and improve the quality management level
of drug distribution.

Article 8: In the process of drug distribution, pharmaceutical retail enterprises shall assess and determine the delivery period based on factors such as distance and road conditions; Equip and select appropriate delivery tools, delivery equipment, and packaging
according to business type, scope, and delivery time.

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

Article 9: Those who use vehicles for drug distribution shall meet the following conditions:

(1) is a closed means of transport of goods;

(2) There is a separate area for placing drugs in the carriage, and there are physical isolation measures to prevent the occurrence of drug contamination, confusion and errors;

(3) Take security measures to prevent drugs from being lost or replaced
during distribution.

Vehicles specializing in the distribution of refrigerated and frozen medicines shall meet the requirements
of the Code on refrigerated trucks.

Article 10: Those who use distribution boxes for drug distribution shall meet the following conditions:

(1) The box body adopts materials with low water absorption, small air permeability, small thermal conductivity and good thermal insulation properties;

(2) Where non-drugs (except medical devices and health foods, the same below) and drugs are distributed in mixed boxes, the storage area of drugs should be physically isolated in the box to ensure that drugs and non-drugs are stored separately;

(3) Install anti-theft devices to prevent drugs from being lost or replaced
during the distribution process.

The distribution boxes for the distribution of refrigerated and frozen drugs shall comply with the requirements
of the Code on incubators (refrigerated boxes).

Article 11: Non-toxic and non-polluting materials shall be selected for packaging and filling materials for the distribution of drugs to avoid the drugs from being broken or squeezed
.
The packaging of drugs with requirements such as temperature and humidity, protection from light, etc.
shall also select packaging materials
that are insulated, moisture-proof and light-proof.

Article 12 The materials for making and delivering delivery notes and delivery packaging seals shall not be easily damaged; The seal should be clearly marked with the word "medicine", and the ink used to print the information is not easy to be wiped or cause blurred handwriting
.
After the distribution package is unopened, the package seal shall not be restored to its original state
.

Article 13 Distribution equipment shall be regularly inspected, cleaned and maintained, and a special person shall be responsible for management, and records and archives
shall be established.

Article 14: Pharmaceutical retail enterprises shall select, review, package, and ship
against consumer purchase records.
The following conditions shall not be shipped:

(1) Problems such as damage, contamination, and seal damage in drug packaging;

(2) There is abnormal noise or liquid leakage in the drug packaging;

(3) The drug label is off, the handwriting is blurred, or the content of the label is inconsistent with the physical object;

(4) The drug has expired or cannot be delivered to consumers within the validity period;

(5) Drugs
with other abnormal circumstances.

Article 15: Pharmaceutical retail enterprises shall properly package the drugs they distribute, and shall meet the following requirements during operation:

(1) Separate packaging of drugs shall not be combined with non-drugs;

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

(3) After the drugs and sales documents are loaded into the packaging, the shape of the packaging should be fixed, and the seal should be used at the seal or other appropriate position to seal it;

(4) Affix and deliver the delivery note on the
outside of the package.
The information recorded in the delivery note includes at least the name and contact information of the pharmaceutical retail enterprise, the name and contact information of the delivery enterprise, and the storage requirements of the drug (such as room temperature, cool, refrigerated, frozen, etc
.
).
The delivery note can also be used as a seal;

(5) The packaging is stored in a specially set up area to be distributed, and the area to be distributed meets the storage conditions
of the drugs to be distributed.

Article 16 The distribution process shall be operated in accordance with the following requirements:

(1) Where distribution boxes are used for distribution, pharmaceutical packaging shall be placed in an orderly manner with appropriate space to avoid crushing and causing damage to the packaging or seal
.
Where it is distributed in mixed boxes with non-drugs, the pharmaceutical packaging shall be placed in the special area for drugs in the distribution box;

(2) If a delivery vehicle is used for transportation, the package shall be placed in the pharmaceutical area
in the carriage.
If the delivery vehicle cannot directly deliver the drug to the consumer, the distribution enterprise shall continue to select other suitable distribution tools in accordance with the delivery requirements;

(3) Where commodities with obvious temperature differences from drug storage requirements are mixed boxes or mixed trucks, effective measures such as temperature insulation and packaging shall be adopted, and verified in accordance with relevant requirements to ensure that drugs continue to meet storage requirements
.

(4) During the distribution process, necessary measures shall be taken to avoid the special external environment such as rain, humidity, high temperature, direct sunlight and severe cold in the process, handover, transfer or transfer;

(5) The distribution of refrigerated or frozen drugs shall also comply with the relevant provisions
of the Norms.

Article 17: Pharmaceutical retail enterprises shall, on the premise of ensuring the quality and safety of drugs, minimize the transit time
for distribution.
Where temporary storage is really necessary during the distribution process, the storage site shall have storage space appropriate to the scale of distribution and meet the relevant conditions
for drug storage.
Temporary storage
of refrigerated and frozen medicines is prohibited.

Article 18: After the delivery of drugs, pharmaceutical retail enterprises shall use effective methods to remind consumers to confirm the delivery information of the drugs and whether the drugs in the delivery packages are damaged or incorrect
.

Article 19: In the event that drugs are not signed for upon delivery or are returned after sale, they shall be handled in accordance with the following requirements:

(1) When the drug is delivered, if the consumer does not sign for the delivery due to the damage to the delivery package, the damaged seal, the inconsistency of the delivery information, or the quality problem of the drugs in the package, the delivery staff shall return it to the pharmaceutical retail enterprise for handling in accordance with the relevant requirements of the Specification;

(2) Where the drug is signed for by the consumer, but it is later discovered that there is a problem with the quality of the drug, the pharmaceutical retail enterprise shall return the drug, and the returned drug must not continue to be sold
.
In other cases, in accordance with the relevant provisions of the Code, in principle, no return will be made
.

Article 20 When a pharmaceutical retail enterprise entrusts the distribution of other drugs, it shall include its distribution activities in its own drug quality management system to ensure that the entrusted distribution process complies with the requirements of the Code and this Appendix:

(1) Verify whether the distribution has an independent drug distribution quality management agency or a person in charge of quality;

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

(3) Sign a entrusted distribution agreement with the distribution, clarifying the quality responsibilities of both parties, the delivery operation procedures, the time limit in transit, and the handling of drug quality and safety accidents
.

Where other refrigerated or frozen drugs are entrusted with the distribution, the distribution facilities and equipment for the distribution of refrigerated or frozen medicines, automatic temperature monitoring systems, etc.
shall also be verified
.

Article 21: Third-party platforms for drug online transactions shall provide conditions for sharing relevant information and data in the process of drug distribution as needed in accordance with the requirements for traceability of drug informatization
.

Third-party platforms for online drug transactions shall conduct a review of relevant distribution enterprises at least once a year, and the review content shall at least include distribution equipment and facilities, personnel qualifications, quality management levels, risk control capabilities, etc.
, and distribution enterprises whose review results do not meet the requirements shall stop cooperating
.

Article 22 The following terms referred to in this Appendix have the following 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 items that have been placed in the packaging such as drugs and sales receipts, and can be delivered after being fixed in shape, sealed and sealed, and posted and delivered with a delivery note
.

Packaging seal refers to the sealing piece
that is used once on the packaging to prevent the drug from being contaminated, lost or replaced during the distribution process after the drug is placed in the package.

A delivery note refers to a label
that contains the delivery information of a drug on the outside of the package.

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