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    Home > Medical News > Latest Medical News > Yunnan Provincial Drug Administration: 33 kinds of banned pesticide testing equipment can be shared within the group

    Yunnan Provincial Drug Administration: 33 kinds of banned pesticide testing equipment can be shared within the group

    • Last Update: 2020-11-05
    • Source: Internet
    • Author: User
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    Medicine Network October 29 - October 27, Yunnan Provincial Drug Administration on the further strengthening of drug production quality management notice.
    In view of the "Chinese Pharmacopoeia" (2020 edition) of Chinese herbal medicine, Chinese medicine drink tablets testing general rules added 33 kinds of banned pesticide testing equipment is expensive, by the production enterprises to equip their own equipment for inspection is more difficult situation.
    from December 30, 2020, during a certain transition period, the production enterprises may share inspection resources within the Group for inspection or entrust third-party testing institutions with statutory inspection and testing qualifications for inspection.
    also stressed that the common inspection resources or commissioned inspection, should develop a corresponding program, improve the relevant system, after risk assessment, the relevant information reported to the provincial bureau for the record.
    this is after Gansu, Anhui, another province made it clear that the group can share inspection equipment.
    Whether to approve inspection, by the enterprise to master the "Chinese Pharmacopoeia" (2020 version) of Chinese herbal medicine, Chinese medicine drink tablets testing general rules added 33 kinds of banned pesticide quality control requirements, not under the variety of factory inspection items, whether the batch inspection can be controlled by enterprises according to the actual situation, but pharmaceutical production enterprises must strictly fulfill the main responsibility of quality, take effective measures to ensure that Chinese herbal medicine, Chinese medicine tablets banned pesticides may not be detected (no quantitative limit).
    The original text is as follows: Pharmaceutical production enterprises: "Vaccine Management Law", the new revision of the "Drug Administration Law" after the implementation of the State Drug Administration has issued a number of supporting regulations, "China Pharmacopoeia" (2020 edition) has also been promulgated and will be implemented on December 30, 2020.
    In order to improve the quality management level of pharmaceutical production, reduce the compliance risk of pharmaceutical production enterprises, and strengthen the supervision and management of drug production in our province, we heed the following notifications on matters related to further strengthening the quality management of drug production in the province: First, to confirm the legality of the standards implemented by drug production, pharmaceutical production enterprises shall, in accordance with existing laws, regulations and documents, The standards of raw materials, accessories, medicinal packages, Chinese herbal medicines, Chinese herbal medicine tablets, preparations, etc. carried out in the process of quality control of the pharmaceutical production of this enterprise shall be checked and combed, and the legality of the standards implemented shall be confirmed, and the non-legal standards such as expiration, failure, annulment or invalidity shall not be enforced.
    II, do a good job in the implementation of the "Chinese Pharmacopoeia" (2020 version) of Chinese herbal medicine, Chinese medicine drink tablets new external pollutants quality control requirements of the bridging preparations "Chinese Pharmacopeia " (2020 edition) Chinese herbal medicine, Chinese medicine tablets testing general rules added 33 kinds of banned pesticides can not be detected (not over quantitative limits) requirements, some varieties also added banned pesticides, heavy Metals, harmful elements, aflatoxin and other project testing requirements, enterprises should in advance to find out the quality and safety of Chinese herbal medicine, Chinese medicine tablets used by enterprises, and take standardized cultivation, breeding, strengthen supplier audit and carry out regular quality inspection and monitoring measures to strengthen the control of Chinese herbal medicine (drink tablets) external pollutants, to ensure that the production of products in line with the "Chinese Pharmacopoeia" (2020 version) requirements.
    III. Strengthen the management of quality inspection and release of pharmaceutical production (1) Pharmaceutical production enterprises shall strictly abide by the quality management norms for drug production, carry out production in accordance with the national drug standards, drug registration standards approved by the drug supervision and administration departments and production processes, and drug production enterprises shall have quality inspection institutions, personnel and necessary equipment appropriate to the drugs produced, and all inspection projects shall be completed in accordance with the provisions of the drug standards for the products released from the factory.
    shall not be released or put on the market if the drug has not completed the factory legal project inspection or the factory inspection fails to meet the requirements.
    (2) According to the relevant provisions of the Notice on Specific Matters in the Process of Drug GMP Certification (National Food and Drug Administration (2004) No. 108), pharmaceutical production enterprises in the inspection of raw materials and packaging materials entering the factory, such as the use of small frequency of large-scale inspection equipment (e.g. nuclear magnetic, infrared, etc.), the corresponding inspection items may be entrusted to qualified units for inspection.
    the relevant entrustment (including change of trustee) shall be reported to the provincial drug regulatory department for the record.
    (iii) In view of the "Chinese Pharmacopoeia" (2020 edition) Of the 33 new prohibited pesticide testing equipment is expensive, by the production enterprises to equip their own equipment for inspection difficult situation, since December 3, 2020 From 0 onwards, within a certain period of transition, the production enterprises may share inspection resources within the Group for inspection or entrust third-party testing institutions with statutory inspection and testing qualifications for inspection, and if they share inspection resources or entrust inspection, they shall formulate corresponding plans, improve the relevant system, and, after risk assessment, report the relevant information to the provincial bureau for the record.
    (4) "China Pharmacopoeia" (2020 edition) Chinese herbal medicine, Chinese medicine tablets testing general rules added 33 kinds of banned pesticide quality control requirements, not under the variety of factory inspection items, whether the batch inspection can be mastered by enterprises according to the actual situation, but pharmaceutical production enterprises must strictly fulfill the main responsibility of quality, take effective measures to ensure that Chinese herbal medicine, Chinese medicine tablets banned pesticides may not be detected (no quantitative limit).
    the implementation of the 2020 Chinese Pharmacopoeia, the provincial bureau will arrange for the supervision and sampling of 33 banned pesticides in 2021 to investigate and punish products and enterprises that do not meet the requirements.
    (5) Pharmaceutical production enterprises may, in accordance with the provisions of Appendix 7 of the Code of Quality Management of Pharmaceutical Production (revised in 2010), apply the inspection results of Chinese herbal medicines, intermediate products and products to be packaged for the quality evaluation of Chinese medicine tablets in order to effectively reduce expenditure and save costs.
    (6) The pharmaceutical production enterprise shall strengthen the audit and supervision of the inspection qualification, inspection ability and inspection level of the entrusted inspection institution of the enterprise to ensure that the inspection results are true and effective.
    provincial bureaus in the daily supervision and inspection and GMP compliance inspection will be entrusted inspection as the focus of inspection, and the joint market regulatory authorities will regularly carry out inspection and inspection of inspection institutions, in accordance with the law to investigate and punish fraud violations.
    Drug Administration of Yunnan Province, China, October 12, 2020
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