echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > Five pharmaceutical companies lost their certificates, and the rain in their hearts poured down

    Five pharmaceutical companies lost their certificates, and the rain in their hearts poured down

    • Last Update: 2016-09-06
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Recently, one pharmaceutical enterprise in Guangxi has been withdrawn GMP certificate; one pharmaceutical enterprise in Chongqing and Anhui has been withdrawn GSP certificate; one pharmaceutical enterprise in Guangdong and Chongqing has been withdrawn GSP certificate One GMP recovered in Guangxi In 2016, Guangxi Guixue Pharmaceutical Co., Ltd took back its GMP certificate in accordance with the provisions of Article 55 of the measures for the supervision and administration of drug production and Article 33 of the measures for the administration of the certification of the drug production quality management specifications due to its serious violation of the provisions of the drug production quality management specifications Chongqing: on September 5, Chongqing food and Drug Administration issued two announcements to withdraw and cancel one GSP respectively The GSP certificate of Chongqing xuanyang Pharmaceutical Co., Ltd and the GSP certificate of Chongqing dingchuang Pharmaceutical Co., Ltd were withdrawn It is pointed out in the announcement that according to the requirements of the Announcement No 94 of 2016 of the State Food and drug administration, during the special rectification flight inspection of illegal operation of drug wholesale enterprises, Chongqing xuanyang Pharmaceutical Co., Ltd was found to have seriously violated the "quality management specifications for drug operation" and had a large risk of drug operation quality and safety; Chongqing dingchuang Pharmaceutical Co., Ltd seriously violated the "quality management regulations for drug operation" There are major quality and safety risks in drug trade In order to strengthen risk prevention and control, according to Article 25 of the measures for flight inspection of medical and pharmaceutical devices (Order No 14 of the State Food and Drug Administration), Chongqing food and drug administration has withdrawn the certificate of quality management standard for pharmaceutical business of Chongqing xuanyang Pharmaceutical Co., Ltd and the certificate of quality management standard for pharmaceutical business of Chongqing dingchuang Pharmaceutical Co., Ltd according to law The cancellation of yihetang drugstore in Zijin County, a GSP drugstore, in Guangdong Province, seriously violates the provisions of the "drug trade quality management specifications" and revokes its "drug trade quality management specifications certification certificate" in accordance with the provisions of the "measures for the administration of drug trade quality management specifications certification" and other regulations, which is now publicly distributed On September 5, Anhui Provincial Food and Drug Administration issued a notice to withdraw a GSP and the certificate of quality management standard for drug distribution of Wuhu rendetang Pharmaceutical Co., Ltd From August 25 to 26, 2016, Anhui food and Drug Administration organized the flight inspection team to carry out flight inspection on Wuhu rendetang pharmaceutical Western pharmaceutical business Co., Ltd in accordance with the measures for flight inspection of pharmaceutical and medical devices (Order No 14 of the State Food and Drug Administration) The inspection found that the enterprise had violated the "quality management standards for drug trading" (Order No 13 of the State Food and Drug Administration) According to Article 40 of the measures for the administration of quality management standard certification of drug distribution (gsyj [2003] No 25), the guiding principles of on-site inspection in Anhui Province (wsyj [2014] No 237), After research, it is confirmed that the drug handling behavior of the enterprise does not conform to the "drug handling quality management specification" According to the "measures for flight inspection of medical and pharmaceutical devices" and "opinions on the implementation of certification and management of drug handling quality management specification in Anhui Province" (wsyjyhl [2014] No 26), the "drug handling quality management specification" of the enterprise is withdrawn by the food and Drug Administration of Anhui Province according to law Certification certificate.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.