Chinese herbal medicines production quality management standard certification management measures of Chinese herbal medicines production quality management standard certification management measures

(Trial)

Article 1 According to the "Drug Administration Law" and "Drug Administration Law Enforcement Regulations" of the relevant provisions of the "Drug Administration Law", in order to strengthen the supervision and management of the production of Chinese herbal medicines, standardize the "production of Chinese herbal medicines quality management standard (Trial)" (Good Agricultural Practice for Chinese Crude Drugs, referred to as Chinese herbal medicines GAP) certification. , referred to as GAP for Chinese herbal medicines) certification, the development of this approach.

Second, the State Food and Drug Administration is responsible for the national GAP certification of Chinese medicinal herbs; responsible for the GAP certification of Chinese medicinal herbs, inspection and evaluation of standards and related documents, the development and revision of the work; responsible for the GAP certification of Chinese medicinal herbs, the inspector's training, assessment and appointment and other management.

State Food and Drug Administration Drug Certification and Management Center (hereinafter referred to as "Bureau Certification Center") to undertake the specific work of GAP certification of Chinese herbal medicines.

Third, provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration) is responsible for the administrative region of the GAP certification of Chinese herbal medicines manufacturers to declare the preliminary examination of information and through the daily supervision and management of Chinese herbal medicines GAP certified enterprises.

Fourth apply for Chinese herbal medicines GAP certification of Chinese herbal medicines manufacturers, the declaration of species at least one production cycle. Declare the need to fill out the "Chinese herbal medicines GAP certification application form" (in duplicate), and to the province, autonomous region, municipalities directly under the Central Food and Drug Administration (Drug Administration) to submit the following information:

(a) "Business License" (copy);

(b) declared varieties of planting (farming) history and scale, ecological environment of the origin, varieties of source and identification, germplasm Source, distribution of wild resources and information on the growth habits of plants and animals of Chinese herbal medicines, breeding of good seeds, suitable harvesting time (harvesting year, harvesting period) and the basis for determining, integrated control of pests and diseases, quality control and evaluation of Chinese herbal medicines, etc.;

(c) Overview of the production enterprises of Chinese herbal medicines, including the organizational form with an organizational chart (indicating the names of the various departments and their responsibilities), the operating mechanism, personnel structure, background information of the person in charge of the enterprise, the person in charge of the production and quality departments (including specialty, education and experience), personnel training, etc.;

(iv) planting (farming) flow charts and key technical control points;

(v) planting (farming) area layout map (indicating the scale, output and scope);

(vi) planting (farming) location selection basis

(vii) ecological environment of origin test report (including soil, irrigation water, atmospheric environment), varieties of source identification report, statutory and enterprise internal control quality standards (including quality standards based on and drafting instructions), sampling methods and quality inspection report, quality control and testing over the years;

(viii) production management of traditional Chinese medicinal herbs, quality management documents catalog;

(viii) production management of traditional Chinese medicinal herbs, quality management documents;

(viii) production management of traditional Chinese medicinal herbs, quality management documents catalog;< /p>

(ix) enterprise implementation of Chinese herbal medicines GAP self-examination summary information.

Article V Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration) shall receive from the date of declaration of Chinese herbal medicines GAP certification within 40 working days of the preliminary opinion. In line with the provisions of the initial review and certification information will be forwarded to the State Food and Drug Administration.

Sixth, the State Food and Drug Administration organization of the preliminary examination of qualified Chinese herbal medicines GAP certification information on the form of review, if necessary, can ask experts to demonstrate that the review work time limit of 5 working days (if the need to organize expert demonstration, can be extended to 30 working days). Meet the requirements to be accepted and transferred to the certification center.

Article VII of the Bureau of Certification Center within 30 working days after receiving the application information to put forward technical review, the development of on-site inspection program. Inspection program includes scheduling, inspection items, inspection team members and division of labor, etc., such as the need to verify the issues should be included in the scope of the inspection. On-site inspection is generally scheduled in the harvest period of the variety, the time is generally 3-5 days, and can be appropriately extended if necessary.

Article VIII of the inspection team members are selected to follow the principle of avoidance within the administrative region, generally composed of 3-5 inspectors. According to the needs of the inspection work, relevant experts may be temporarily appointed as inspectors.

Article IX Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration) may choose to send a person responsible for the supervision and management of the production of Chinese medicinal herbs as observers, liaison and coordination of inspection matters.

The tenth on-site inspection of the first meeting should confirm the inspection of varieties, the implementation of the inspection schedule, announced the inspection discipline and precautions, to determine the company's inspection accompanied by personnel. Inspection accompanying personnel must be the person in charge of the enterprise or the production of Chinese herbal medicines, quality management department in charge, familiar with the whole process of production of Chinese herbal medicines, and be able to answer the relevant questions raised by the inspection team.

Article XI of the inspection team must be strictly in accordance with the scheduled on-site inspection program on the implementation of the enterprise GAP of Chinese herbal medicines. The defective items found during the inspection shall be faithfully recorded, and evidence shall be taken when necessary. If any information is required to be provided by the enterprise during the inspection, the enterprise shall provide it in time.

Article XII of the end of the on-site inspection, the inspection team leader to organize the inspection team to make a comprehensive assessment of the discussion, the formation of a written report. Comprehensive assessment of the period, the inspection of the enterprise personnel should be avoided.

Article XIII of the on-site inspection report shall be signed by all personnel of the inspection team, and attached to the lack of foreign currency banknote entry and exit management of the interim measures to carry foreign currency banknote entry and exit management of the interim measures to trap the project, the inspector's records, the views of the objectionable issues and related evidence.

Article 14 The final meeting of the on-site inspection shall announce on-site the comprehensive evaluation opinions. The inspected enterprise may arrange for relevant personnel to attend. If the enterprise has different opinions on the evaluation opinions and the defective items found in the inspection, it can make appropriate explanations and clarifications. The inspection team shall adopt the reasonable opinions put forward by the enterprises.

Article 15 The defective items found in the inspection shall be signed by all the staff of the inspection team and the person in charge of the inspected enterprise, with one copy for each side. If there is any problem that can not be reached, the inspection team shall make a record, signed by all members of the inspection team and the person in charge of the inspected enterprise, each party shall take a copy.

Article XVI of the on-site inspection report, defective item list, each inspector on-site inspection records and original evaluation and related information should be submitted to the Bureau of Certification Center within five working days after the completion of the inspection work.

Article XVII of the Bureau Certification Center within 20 working days after receipt of the on-site inspection report for technical review, in line with the provisions of the State Food and Drug Administration for approval. In line with the "production quality management standard for Chinese herbal medicines," the issuance of "Chinese herbal medicines GAP certificate" and be announced.

Article XVIII of the on-site inspection does not meet the standards of GAP certification of Chinese herbal medicines, not through the GAP certification of Chinese herbal medicines, by the Bureau of Certification Center to the inspected enterprises to send certification failure notice.

Article XIX of the certification failed enterprises to apply again for GAP certification of Chinese herbal medicines, as well as obtaining GAP certificate of Chinese herbal medicines to change the planting (breeding) area (location) or to expand the scale, etc., should be in accordance with the provisions of Article IV of these measures.

Article 20 "Chinese herbal medicines GAP certificate" is generally valid for five years. Producers should be in the "Chinese herbal medicines GAP certificate" six months before the expiration of the limited period, in accordance with the provisions of Article IV of these measures to reapply for Chinese herbal medicines GAP certification.

Article 21 of the "Chinese herbal medicines GAP certificate" by the State Food and Drug Administration unified printing, should contain the certificate number, enterprise name, legal representative, the person in charge of the enterprise, the registered address, planting (farming) area (location), certified varieties, planting (farming) scale, the issuance of authority, the date of issuance of certificates, the expiration date and other items.

Article 22 The Chinese herbal medicine GAP certification inspector shall have the following conditions:

(1) abide by the law, integrity, adherence to principle, and seek truth from facts;

(2) be familiar with and master the national drug supervision and management of relevant laws and regulations and guidelines and policies;

(3) have a university degree in traditional Chinese medicine or intermediate or above, and have more than 5 years engaged in the Chinese medicine supervision and management of laws and regulations.

(d) be able to correctly understand the principles of GAP for Chinese herbal medicines and accurately grasp the inspection standards for GAP certification of Chinese herbal medicines;

(e) be physically capable of performing on-site inspections and be free of infectious diseases;

(f) be able to comply with the selection and actively participate in the GAP certification of Chinese herbal medicines on-site inspection work.

Article 23 The Chinese herbal medicines GAP certification inspector should be recommended by the unit, fill out the "National Chinese herbal medicines GAP certification inspector recommendation form", signed by the provincial Food and Drug Administration (Drug Administration) reported to the State Food and Drug Administration for accreditation.

Article 24 of the State Food and Drug Administration is responsible for the GAP certification of Chinese herbal medicines inspectors for the annual review, unqualified to be dismissed.

Article 25 of the Chinese herbal medicine GAP certification inspector assigned by the State Food and Drug Administration, to undertake the production of Chinese herbal medicine GAP certification on-site inspection, follow-up inspection and other work.

Article 26 The Chinese herbal medicine GAP certification inspectors must strengthen their own cultivation and knowledge update, and constantly improve the Chinese herbal medicine GAP certification inspection of business knowledge and policy level.

Article 27 The Chinese herbal medicine GAP certification inspector must abide by the Chinese herbal medicine GAP certification inspector code and on-site inspection discipline. Violation of the relevant provisions, be criticized and educated, the circumstances are serious, cancel the qualification of Chinese herbal medicines GAP certification inspector.

Article 28 The State Food and Drug Administration is responsible for organizing the acquisition of "Chinese herbal medicines GAP certificate" of the enterprise, according to the characteristics of the growth of varieties to determine the frequency of inspection and focus on follow-up inspection.

Article 29 In the "Chinese herbal medicines GAP certificate" validity period, provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration) is responsible for the annual follow-up inspection of the enterprise, tracking and inspection of the situation should be promptly reported to the State Food and Drug Administration.

Article 30 to obtain "Chinese herbal medicines GAP certificate" of the enterprise, such as the occurrence of major quality problems or not in accordance with the GAP organization of production of Chinese herbal medicines, the State Food and Drug Administration will be warned and ordered to make corrections; the circumstances are serious, it will be revoked, "Chinese herbal medicines GAP certificate".

Article 31 Obtained the "Chinese herbal medicines GAP certificate" of Chinese herbal medicines manufacturers, such as the declaration process is found to take fraudulent certificate, or non-certified enterprises to produce Chinese herbal medicines to pretend to be certified enterprises to produce Chinese herbal medicines for sale and use of serious problems, once verified, the State Food and Drug Administration will revoke its "Chinese herbal medicines GAP certificate".

Article 32 The Chinese herbal medicines manufacturer "Chinese herbal medicines GAP certificate" registration matters change, should be in the matter of change within 30 days from the date of change, to the State Food and Drug Administration to apply for the change procedures, the State Food and Drug Administration should be within 15 working days to make the corresponding changes.

Article 33 of the Chinese herbal medicines production enterprises to terminate the production of Chinese herbal medicines or closed, by the State Food and Drug Administration to withdraw the "Chinese herbal medicines GAP Certificate".

Article 34 The application for Chinese herbal medicines GAP certification of Chinese herbal medicines manufacturers should pay the certification fee in accordance with relevant regulations. Failure to pay the required certification fees, suspend the certification or withdraw the "Chinese herbal medicines GAP certificate.

Article 35 The State Food and Drug Administration is responsible for the interpretation of these measures.

Article 36 These measures shall November 1, 2003 shall come into force.