Specification For Quality Control Of Veterinary Drugs

Original Language Title: 兽药经营质量管理规范

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Read the untranslated law here: http://www.chinalaw.gov.cn/article/fgkd/xfg/gwybmgz/201007/20100700259027.shtml

Specification for quality control of veterinary drugs

    (January 15, 2010 2010 3rd release from the Ministry of agriculture as of March 1, 2010) Chapter I General provisions

    First to strengthen the quality control of veterinary drugs, ensure the quality of veterinary drugs, in accordance with the regulations on the management of veterinary drugs, development of this specification.

    Article of this code applies to People's Republic of China territory of veterinary drug enterprises.

    Chapter II sites and facilities Article veterinary medicine business enterprise should have a fixed place of business and the warehouse, its area shall conform to the provinces, autonomous regions and municipalities directly under the provisions of the veterinary Administrative Department under the people's Government.

    Business premises and warehouses should be reasonable and relatively independent. Area of the premises, facilities and equipment should be adapted to variety, scale of operation and management of veterinary drugs.

    Veterinary medicine business area and living area, animal diagnosis and treatment area should be set separately to avoid cross contamination. The place of business of the fourth veterinary drugs business should set forth the location with the veterinary license agreement.

    The veterinary business shall be suspended in the business place prominently.

    Change of place of business shall apply for renewal of the veterinary drug license.

    Change area of the premises shall, within 30 days of the change of issuing authority record.

    Fifth business enterprises shall have the management of veterinary drugs veterinary drugs, scale adaptation and able to guarantee the quality of veterinary medicine library, cool at room temperature (Cabinet), freezer (counter), such as warehousing and related facilities and equipment.

    Warehouse areas, and related facilities, equipment should meet the qualified veterinary drugs, substandard veterinary drugs, quarantine veterinary drugs, return of veterinary drugs in different regions and different varieties of veterinary drug Division, classification, storage, storage requirements.

    Change the warehouse location, increase, reduce the number of warehouses, areas, and related facilities and equipment, shall, within 30 days of the change of issuing authority record.

    Sixth direct chain of veterinary drugs operating enterprises in the same counties (cities) of operating in a number of stores, warehousing and related facilities and equipment can be configured unified.

    Seventh veterinary business premises and warehouse floors, walls, ceilings, etc shall be flat, smooth, doors and Windows should be tight and easy to clean.

    Article eighth veterinary drugs business establishments shall have the following facilities, equipment and warehouse:

    (A) and the operation of veterinary drugs suitable shelf, counter;

    (B) avoid light, ventilation and lighting facilities, equipment

    (C) and storage of veterinary drugs suitable for controlling temperature and humidity of facilities and equipment;

    (D) dust, moisture, mold, pollution prevention and insect, rodent, bird-proof facilities and equipment;

    (E) sanitary facilities, equipment, etc.

    Nineth veterinary business premises and warehouses facilities, equipment should be complete, clean and in good condition, and according to the varieties and categories, uses, such as the establishment of veterinary drugs logo.

    Chapter III organization and personnel

    Article tenth of veterinary drug enterprises officers directly in charge of veterinary drug management should be familiar with the laws, regulations and policies, with the corresponding knowledge of veterinary drugs. 11th veterinary medicine business enterprise shall be equipped with quality management in conformity with operating veterinary drugs.

    Conditions, you can set up quality management organization.

    12th quality of veterinary medicine business executives head and head of quality management organization should have the corresponding expertise of veterinary drugs and their professional or technical title shall comply with the provinces, autonomous regions and municipalities directly under the provisions of the veterinary Administrative Department under the people's Government. Veterinary drug quality management should have veterinary drugs, veterinary and related background, or with veterinary medicine, veterinary medicine and other related professional junior professional titles.

    Management of veterinary Biologics, veterinary drug quality management should have veterinary medicine, veterinary medicine and other related professional college education, or with veterinary medicine, veterinary medicine and other related professional more than mid-level professional titles, and veterinary Biologics expertise.

    Veterinary drug quality in units other than those of the Enterprise Manager may work part-time.

    In charge of quality, quality management, head of Heads of institutions, quality managers is changed, shall, within 30 days of the change of issuing authority record.

    13th veterinary drug enterprises engaged in veterinary drug procurement, storage, sales, technical and service staff working, should have a high school education, and have the appropriate expertise such as veterinary medicine, veterinary, familiar with veterinary drug management law, regulations and policy provisions.

    14th veterinary drug enterprises should develop a training plan, and regular staff of veterinary drug management law and regulations, policies and related expertise, ethics training, assessment, and establish a training, assessment files.

    The fourth chapter rules and regulations

    15th enterprise quality management system should be established for veterinary drugs, developing management systems, procedures and other quality management documents.

    Quality management documents shall include the following:

    (A) quality management objectives;

    (B) the Organization, job and personnel responsibilities;

    (C) on the supply unit and the purchase of veterinary drug quality assessment system;

    (D) veterinary drugs purchase, acceptance, storage, display, storage, transportation, sales, outbound link management system;

    (E) environmental management systems;

    (F) the veterinary drug adverse reaction reporting system;

    (VII) failed and return of veterinary drugs veterinary drugs management system;

    (H) quality, quality queries and complaints about the quality management system;

    (I) the corporate records, archives and document management system;

    (J) training, assessment of quality management systems.

    16th veterinary medicine business enterprise shall set up the following records:

    (A) staff training and appraisal records;

    (B) to control the temperature and humidity of the facilities, equipment, maintenance, repair, cleaning, and running record;

    (C) the veterinary drug quality assessment records;

    (D) veterinary drugs purchase, acceptance, storage, storage, sales, library and other records;

    (E) inventory records of veterinary drugs;

    (F) the quality of veterinary medicine quality complaints, disputes, accidents, adverse records;

    (VII) veterinary drug dealings of substandard veterinary drugs and return;

    (H) the Veterinary Administration of the supervision and inspection of records. Records shall be true, accurate, complete, legible, shall not be altered, forged or altered.

    Necessitates modification shall be signed and dated, the original data should be clearly visible.

    Article 17th of veterinary drug enterprises should establish veterinary drug quality control files, setting file management Chamber or a filing cabinet, and by the person in charge.

    Quality management record should include:

    (A) the personnel, training, equipment and facilities Archives Archives Archives, product quality, supplier quality assessment files;

    (B) issuing the prescription, purchase and sales documents;

    (C) purchase and sale records and other records specified in this specification.

    Quality management archive may not be altered, retained for periods of not less than 2 years; purchase and sale records and supporting documents shall be kept until one year after the expiration date.

    The fifth chapter purchasing and storage 18th article veterinary drug enterprises must purchase illegal veterinary drug products.

    Veterinary drug distribution enterprises shall supply units of qualifications, quality assurance, quality reputation and product approval documents for approval and procurement contracts with the supplier. Article 19th enterprises when purchasing veterinary drugs veterinary drugs, shall, in accordance with national regulation of veterinary drugs, veterinary drugs and contract standards, each batch of veterinary drugs packaging, labels, specifications, quality certification, review content, meet the requirements of the party can be purchased.

    If necessary, buy veterinary drugs should be tested or inspected by the veterinary drug inspection institutions to conduct inspection, inspection reports and product quality should be saved with the file. Business enterprise should purchase valid certificate of veterinary drugs veterinary drugs, establish real and complete record of procurement, so that valid documents, accounts and goods in line.

    Procurement records shall set forth the veterinary drugs generic name, trade name, approval number, batch number, dosage form, specifications, availability, production units, delivery units, purchase number, purchase date, sponsor, or person in charge, and so on.

    Article 20th veterinary drug storage, inspection should be carried out and recorded.

    Have one of the following veterinary drug, not storage:

    (A) conformity with the list;

    (B) the internal and external packaging damage may affect the quality of products;

    (C) no identity or identity ambiguous;

    (Iv) quality;

    (E) other irregularities.

    Veterinary biological products in storage, should be checking by two or more persons.

    The sixth chapter on display and storage

    21st exhibition, storing veterinary medicines shall comply with the following requirements:

    (A) according to species, category, use, and storage requirements, such as temperature, humidity, category, area or inventory;

    (B) in accordance with the requirements of veterinary drug packaging graphic mark handling and storage;

    (C) warehouse maintains a certain distance between the floors, walls, and so on;

    (D) veterinary drugs veterinary drugs for external use in separate, use of prescription and non-prescription drugs for animals separate;/or veterinary drugs, dangerous drugs special veterinary drugs and other veterinary drug store;

    (E) to be inspected, qualified veterinary drugs veterinary drugs, substandard veterinary drugs, veterinary drug partition returns storage;

    (F) the product of the same batch number of the same enterprise storage. 22nd different regions, different types of animal drugs should have a clear identity.

    Logo should be placed accurately and clearly legible.

    Identified substandard veterinary drugs in red; quarantine and veterinary drug to return the yellow font identification; qualified veterinary drugs identified in green.

    Article 23rd veterinary medicine veterinary drug and its trading enterprises shall, on a regular basis exhibitions, storage, check the condition and operation of the facilities, equipment, and records.

    Article 24th of veterinary drug enterprises should timely inventory published fake veterinary drugs veterinary administrative departments, and completes the record.

    The seventh chapter sales and transport 25th business sales of veterinary drugs veterinary drugs, should be followed by batch number and first in, first out principle. Veterinary Medicine Library, check, checks should be carried out, establishing a library records.
Veterinary Medicine Library records should include veterinary drugs generic name, trade name, batch number, dosage form, specifications, manufacturer, quantity, date, sponsor, or person in charge, and so on.

    Have one of the following veterinary drug, may not be sold out:

    (A) identifies the blurring or loss;

    (B) the package appears damaged, sealing unsound, seals are damaged;

    (C) beyond the expiration date;

    (Iv) other irregularities. 26th veterinary medicine business enterprise shall set up sales records.

    Sales records shall set forth the veterinary drugs generic name, trade name, approval number, batch number, expiry date, dosage form, specifications, manufacturers, purchases, sales quantity, date of sale, handling or responsible person and so on.

    27th enterprise sales of veterinary drugs veterinary drugs to be issued shall be valid documents, valid documents, accounts, cargo, consistent record.

    28th business sales of veterinary drugs, veterinary prescription drugs shall comply with veterinary use prescription management; sales of veterinary Chinese herbal medicine, Chinese herbal medicine, you should indicate the origin.

    Article 29th standardizes sales of veterinary drugs, may not take apart the smallest sales unit. Veterinary drug trading enterprises shall, in accordance with article 30th packaging transportation graphic mark requirements of veterinary drugs veterinary drugs.

    Temperature control of veterinary drugs in transport temperature control measures should be taken when necessary, and to maintain detailed records.

    The eighth chapter service

    31st trading enterprises shall be approved by the Veterinary Administration of veterinary drugs veterinary drug labels, brochures and other publicity shall not mislead buyers.

    Article 32nd veterinary drug distribution enterprises shall provide technical advisory services to buyers, service and quality commitment to the Convention explicitly in the premises to guide buyers science, safety and rational use of veterinary drugs.

    Article 33rd enterprises should pay attention to the collection of veterinary drugs veterinary drug use information, find the false and inferior veterinary drugs and quality questionable veterinary drugs, and serious adverse veterinary drug reactions, shall promptly report to the local veterinary administrative departments, and according to the provisions of the relevant work.

    Nineth chapter by-laws

    Article 34th veterinary drug distribution business, veterinary narcotic drugs, psychotropic substances, precursor chemicals, poisonous drugs, radioactive drugs, special drugs should also comply with the other relevant regulations of the State.

    35th animal epidemic prevention institutions engaged in the operation of the veterinary drug, shall comply with this specification.

    Article 36th in all provinces, autonomous regions and municipalities directly under the veterinary administrative departments under the people's Government of this code, combined with local conditions, formulate rules for its implementation, and report to the Department of agriculture records.

    37th article of the specifications come into force on March 1, 2010. This specification has been introduced before the implementation of veterinary drug enterprises shall, within 24 months from the date of implementation of this standard meet the requirements of this standard, and shall apply for a license for veterinary drugs.