Order No. 20 of the Drug Administration for qualit

2022-05-27
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The code for the quality management of drug trade (Order No. 20 of the State Drug Administration)

Director general: Zheng Xiaoyu

specifications for the quality management of pharmaceutical trading

Chapter I General Provisions

Article 1 in order to strengthen the quality management of pharmaceutical trading and ensure the safety and effectiveness of people's drug use, these specifications are formulated in accordance with the drug administration law of the people's Republic of China and other relevant laws and regulations

Article 2 pharmaceutical trading enterprises shall implement quality management in the purchase, storage, transportation and sales of drugs, establish a quality system including organizational structure, responsibility system, process management, facilities and equipment, and make it operate effectively

Article 3 this specification is the basic criterion for the quality management of drug trading, which is applicable to the exclusive or part-time enterprises dealing in drugs within the territory of the people's Republic of China after the main body and dynamometer are respectively transported to the concrete

Chapter II quality management of drug wholesale

section 1 management responsibilities

Article 4 the main person in charge of the enterprise shall ensure that the enterprise implements relevant national laws, regulations and this specification, and be responsible for the quality of drugs handled by the enterprise

Article 5 the enterprise shall establish a quality leadership organization headed by the main person in charge of the enterprise. Its main responsibilities are to establish the quality system of the enterprise, implement the quality policy of the enterprise, and ensure that the quality management staff of the enterprise exercise their functions and powers

Article 6 an enterprise shall set up a special quality management organization to exercise the function of quality management and have the power to adjudicate the drug quality within the enterprise

Article 7 the enterprise shall set up drug inspection departments and acceptance, maintenance and other organizations appropriate to the business scale. The drug inspection department and the acceptance organization shall be subordinate to the quality management organization

Article 8 an enterprise shall formulate a quality management system in accordance with relevant laws, regulations and this specification and in combination with the actual situation of the enterprise, and regularly check and assess the implementation of the system

Article 9 the enterprise shall regularly conduct internal review on the implementation of this specification to ensure the implementation of the specification

section II personnel and training

Article 10 the main person in charge of an enterprise shall have professional and technical titles and be familiar with the laws, regulations and rules of the state on drug administration and the knowledge of the drugs handled

Article 11 the person in charge of the enterprise shall have personnel with pharmaceutical professional and technical titles to be responsible for quality management

Article 12 the person in charge of the enterprise's quality management organization shall be a licensed pharmacist or have the corresponding professional and technical title of pharmacy, adhere to principles, have practical experience, and can independently solve quality problems in the process of operation

Article 13 the person in charge of the drug inspection department shall have the corresponding professional and technical title of pharmacy

Article 14 the personnel engaged in quality management and inspection in an enterprise shall have an educational background in pharmacy or related majors, or have a professional and technical title in pharmacy. They shall take up their posts with certificates after professional training and passing the examination

Article 15 personnel engaged in acceptance, maintenance, measurement, storage and other work shall have corresponding educational background or certain educational level, and work with certificates after relevant training and passing the examination

those who work in posts with national employment access regulations can only take up their posts after passing the vocational skill appraisal and obtaining the vocational qualification certificate

Article 16 every year, the enterprise shall organize the personnel in direct contact with drugs to have a health examination and establish a health file. Patients who are found to be suffering from mental illness, infectious disease or other diseases that may pollute drugs shall be transferred from the post in direct contact with drugs

Article 17 the enterprise shall regularly educate or train all kinds of personnel in drug laws, regulations, rules, professional technology, drug knowledge and professional ethics, and establish archives

section III facilities and equipment

Article 18 an enterprise shall have a business place and auxiliary and office buildings suitable for its business scale. The business place shall be bright and tidy

Article 19 there are warehouses suitable for the business scale. The ground of the reservoir area shall be flat, free of ponding, weeds and pollution sources, and shall be:

(I) the drug storage operation area, auxiliary operation area and office and living area shall be separated by a certain distance or isolation measures, and all ceilings of the loading and unloading operation site shall be provided

(II) there is a warehouse suitable for classified storage of drugs and meeting the requirements of drug storage. The walls, ceiling and ground in the warehouse are smooth and flat, and the door and window structure is tight

(III) the reservoir area has fire-fighting and safety facilities that meet the specified requirements

Article 20 the warehouse shall be divided into to be inspected warehouse (area), qualified product warehouse (area), delivery warehouse (area), and unqualified products with mechanical properties corresponding to the function of treatment or tissue regeneration; In special places such as product warehouse (area) and return warehouse (area), the operation of traditional Chinese medicine decoction pieces shall also be divided into parts and take special warehouse (area). The above warehouses (areas) shall be provided with obvious signs

Article 21 the warehouse shall have the following facilities and equipment:

(I) equipment to maintain a certain distance between drugs and the ground

(II) equipment for avoiding light, ventilation and drainage

(III) equipment for detecting and adjusting temperature and humidity

(IV) dust proof, moisture-proof, mildew proof, pollution proof and insect, rat and bird proof equipment

(V) lighting equipment meeting the requirements of safe power consumption

(VI) workplaces and storage places and equipment of packaging materials suitable for disassembly and LCL shipment

Article 22 special warehouses for storing narcotic drugs, class I psychotropic drugs, toxic drugs for medical use and radioactive drugs shall have corresponding security measures

Article 23 there are drug inspection departments corresponding to the business scale and scope, equipped with corresponding inspection instruments and equipment. A herbarium (cabinet) of traditional Chinese medicine shall be set up for those engaged in the business of traditional Chinese medicine and decoction pieces of traditional Chinese medicine

Article 24 there shall be an acceptance and maintenance room suitable for the scale of the enterprise and in line with the hygiene requirements, equipped with necessary tools, instruments and equipment for acceptance and maintenance

Article 25 the facilities and equipment used shall be inspected, repaired and maintained regularly, and archives shall be established

Article 26 there shall be a special place for repacking Chinese herbal pieces, and its area and equipment shall meet the repacking requirements

Section IV purchase

Article 27 An enterprise shall put quality first in the selection of drugs and suppliers, and formulate purchase procedures that can ensure that the purchased drugs meet the quality requirements

Article 28 drugs purchased shall meet the following basic conditions:

(I) drugs produced or sold by legal enterprises

(II) have legal quality standards

(III) unless otherwise specified by the state, there shall be a legal approval number and production batch number. Imported drugs shall have copies of the registration certificate of imported drugs and the inspection report of imported drugs that meet the regulations and are stamped with the original seal of the quality inspection institution of the supplier

(IV) the packaging and identification shall comply with relevant regulations and storage and transportation requirements

(V) the origin of Chinese medicinal materials shall be indicated

Article 29 An enterprise shall conduct an examination of the first enterprise, including qualification and quality assurance ability. The audit shall be conducted jointly by the business department and the quality management organization. In addition to reviewing relevant materials, field investigation shall be conducted when necessary. Only after being examined and approved, can we purchase goods from the first enterprise

Article 30 the enterprise shall review the legality and basic quality of the first varieties (including new specifications, new dosage forms, new packaging, etc.) and can operate only after passing the review

Article 31 when preparing the purchase plan, the enterprise shall take the drug quality as an important basis and have the participation of the personnel of the quality management organization

Article 32 the quality terms shall be specified when signing the purchase contract

Article 33 drugs purchased shall have legal bills, and purchase records shall be established according to regulations to ensure the consistency of bills, accounts and goods. Purchase records shall be kept as required

Article 34 the enterprise shall conduct quality review on the purchase every year

Article 35 the quality acceptance of drugs purchased and sold shall be carried out in strict accordance with the provisions of the contract

(II) during acceptance, the packaging, labels, instructions and certificates or documents of relevant requirements of drugs shall be checked one by one

(III) the samples taken for acceptance shall be representative

(IV) acceptance records shall be made according to relevant regulations. The acceptance records shall be kept for more than one year, but not less than three years

(V) the inspection of the internal quality of drugs shall also be carried out when the first varieties are accepted

(VI) the acceptance shall be carried out in a place that meets the regulations and completed within the specified time limit

Article 36 the warehouse keeper shall receive the goods with the signature or seal of the inspector. Have the right to reject the goods that are inconsistent with the order, abnormal quality, loose or damaged packaging, fuzzy marks, etc., and report to the relevant departments of the enterprise for handling

Article 37 the drug inspection department of an enterprise shall undertake the inspection task of drug quality of the enterprise and provide accurate and reliable inspection data

Article 38 the number of sampling inspection batches by the drug inspection department shall reach the specified proportion of the total incoming batches

Article 39 the main contents of drug quality acceptance and inspection management are:

(I) collection, distribution and storage of drug quality standards and relevant regulations

(II) sampling principles and procedures, and operating procedures for acceptance and inspection

(III) treatment methods of problematic drugs found

(IV) regular calibration and verification of instruments, equipment and measuring tools, use, maintenance and registration of instruments, etc

(V) establishment, collection, archiving and safekeeping of original records and drug quality archives

(VI) collection and storage of traditional Chinese medicine specimens

Article 40 the enterprise shall carry out control management of unqualified drugs, and the key points of management are:

(I) unqualified drugs shall be reported according to the specified requirements and procedures

(II) identification and storage of unqualified drugs

(III) find out the causes of unqualified quality, distinguish the quality, deal with it in time and formulate preventive measures

(IV) records of scrapping and destruction of unqualified drugs

(V) summary and analysis of treatment of unqualified drugs

section 6 storage and maintenance

Article 41 drugs shall be stored in a special warehouse and classified according to the specified storage requirements. The following points shall be observed during storage: according to the different measures and means taken

(I) drugs shall be stored in the corresponding warehouse according to the requirements of temperature and humidity

(II) all drugs in stock shall be subject to color code management

(III) the handling and stacking shall strictly comply with the requirements of the schematic mark of the outer packaging of drugs and operate in a standardized manner. The stacking height of drugs that are afraid of pressure shall be controlled and the stacking shall be turned over regularly

(IV) there shall be corresponding spacing or isolation measures between the drugs and the floor, wall, top and radiator of the warehouse

(V) drugs shall be stacked according to batch number. Drugs with expiration date shall be stored in a relatively centralized manner by classification, and stacked in sequence or separately according to batch number and expiration date, with obvious marks

(VI) drugs and non drugs, internal and external drugs, prescription drugs and non prescription drugs shall be stored separately; Drugs, Chinese herbal medicines, Chinese herbal pieces and dangerous goods that are easy to taste shall be stored separately from other drugs

(VII) narcotic drugs, class I psychotropic drugs, toxic drugs for medical use and radioactive drugs shall be stored in a special warehouse or counter, with two persons and two locksWebsite Under Construction
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