Last week，A pharmaceutical company GMP certificate is taken back，GSP certificate of 12 pharmaceutical merchants may be taken back，or being revoked。The following is specific details。

 

  Guangxi:

 

  September 5，Guangxi Food and Drug Administration released information to recover the GMP certificate of Guangxi Guixue Pharmaceutical Co., Ltd.，The reason is in the special rectification of the production of Chinese medicine in Guangxi in 2016，The company has seriously violated the Regulations on the Management of Quality Management of Drug Production，According to Article 55 of the Measures for the Supervision and Administration of Drug Production and Article 33，His "Drug GMP Certificate" was recovered in accordance with the law。

 

  Suspected illegal and illegal behavior:

 

  a、The inspection ability cannot meet the inspection requirements of production species。If: Inspector is not familiar with the detection operation of sulfur dioxide residues，It is also impossible to complete the micro -identification inspection of varieties such as Sisizi and other varieties in accordance with the requirements My stake betting appof the Chinese Pharmacopoeia;、Micro tape。

 

  2、For some original medicinal materials, it is not checked in accordance with regulations and is used for production。For example: Gold and Silver Flower Medicinal Materials (160101) No identification (1)、（2）、Heavy metal and harmful elements、Content measurement item。

 

  3、Putting on the inspection or full inspection of some finished products。Such as the finished licorice (160501) did not make the content measurement、Heavy metal and harmful elements、Inspection of projects such as organic chlorine pesticide residues, etc.。

 

  4、Some inspection reports、The inspection record is not true。If: Fan Ge (160103) finished product inspection original record、Gypsum (160701) inspection report。

 

  5、Quality management chaos，Quality Assurance System fails to run effectively，Audit the release shape and virtual。

 

  Treatment measures:

 

  Guangxi Guixue Pharmaceutical Co., Ltd. The above behavior has seriously violated the relevant provisions of the Drug Management Law and Drug GMP，Guangxi Bureau recovered the company's GMP certificate，The supervisor of the Nanning Municipal Bureau stops production、and deal with the illegal and illegal behavior of the existence of the enterprise in accordance with the law。

 

  Anhui:

 

  According to the news of the Anhui Food and Drug Administration on September 5，August 25th to 26th, 2016，Anhui Food and Drug Administration organized a flight inspection team，According to the "Measures for Flight Inspection of Drugs and Medical Devices" according to the State Food and Drug Administration (State Food and Drug Administration Order No. 14)，Flight examination of Wuhu Rendetang Pharmaceutical Western Medicine Co., Ltd.。

 

  Inspection found that the company has a violation of the "Specifications for the Management of Drug Management" (State Food and Drug Administration Order No. 13)。According to the "Administrative Measures for the Regulations on the Management of Quality Management of Drugs" (Guoshu and Drug Administration Market [2003] No. 25) Article 40，"Anhui Province & LT; Drug Business Quality stake betting appManagement Specification (2012 Amendment) & GT; On -site Inspection Guidance Principles" (Anhui Food and Drug Administration Trial [2014] No. 237)，Study on Study，It is confirmed that the company's drug business behavior is not in line with the "Specifications for the Management of Drug Operations"，According to the "Pharmaceutical Flight Inspection Measures"、"Opinions of the Implementation of the Quality Management Certification Management Management of Drug Management of Anhui Province"，Anhui Food and Drug Administration will recover the company's "Certificate of Quality Management Quality Management Quality Management Certification Certificate"。

 

  Shandong:

 

  September 7，Shandong Food and Drug Administration issued an announcement，Shandong Global Pharmaceutical Group Co., Ltd. violated the relevant provisions of the "Specifications for the Management of Drug Operations"，No longer meets the certification standard，According to the "Administrative Measures for the Management of Quality Management Quality Management", "Measures for Flight Inspection of Drugs and Medical Device", "Shandong Provincial Drug Management Quality Management Certification Management Measures (Trial)，The Shandong Provincial Bureau revokes its "Certificate of Quality stake betting appManagement Specifications for Drug Operations"，It is now announced。

 

  The company’s official website profile shows，Shandong Global Pharmaceutical Group has three subsidiaries，Modern storage facilities that contain more than 7,000 square meters，Core business has covered many regions in Shandong Province and other regions across the country。

 

  Hubei:

 

  September 7，Hubei Provincial Food and Drug Administration issued an announcement，Calculating Hubei Dexin Pharmaceutical Co., Ltd.、Hubei Xuanrui Pharmaceutical Co., Ltd. and Hubei Hisheng Medicine Co., Ltd. violated the "Specifications for the Management Quality Management of Drugs" (State Food and Drug Administration Order No. 13)，According to the "Measures for Flight Inspection of Drug Medical Devices" (Article 14 of the State Food and Drug Administration Order No. 14)，Our Bureau decided to take back the "Drug Operation Quality Management Certificate Certificate" of the above three pharmaceutical wholesale enterprises。

 

  The Hubei Provincial My stake betting appBureau also announced the same day，Hubei Yichang Chinese Medicine Co., Ltd.、Yuan'an Ruifu Xiang Pharmaceutical Co., Ltd.、Wufeng Kangji Pharmaceutical Co., Ltd.、Yingcheng Kangqiao Pharmaceutical Co., Ltd.、Hubei Baisikang Pharmaceutical Co., Ltd. 5 pharmaceutical wholesale enterprises violated the "Specifications for the Management Quality Management of Drugs" (State Food and Drug Administration Order No. 13)，According to the "Measures for Flight Inspection of Drug Medical Devices" (Article 14 of the State Food and Drug Administration Order No. 14)，Our Bureau has been on August 4, 2016、August 15th to recover the "Drug Operation Quality Management Certification Certificate" of the above five pharmaceutical wholesale enterprises。

 

  Liaoning:

 

  September 8，Liaoning Provincial Food and Drug Administration released information，August 24, 2016-August 25，Provincial Bureau Organization Organize your company to implement drug GSP flight inspections，It is found that Liaoning Tianyao Pharmaceutical Co., Ltd. seriously violates the relevant provisions of the "Specifications for Quality Management of Drugs"，According to Article 25 of the Measures for Flight Inspection of Drugs and Medical Device，Provincial Bureau decided to take back the company's "GSP certificate，and require the company to comprehensively rectify the problems and quality hidden dangers of quality，Establish and improve the quality management system，Make sure to operate in accordance with regulations。

 

  According to news from the Liaoning Provincial Food and Drug Administration，August 26, 2016-August 27th，The Liaoning Provincial Bureau organizes the implementation of the drug GSP flight inspection of Drugs in Liaoning Yongxing Pharmaceutical Distribution Co., Ltd.，It is found that your company seriously violates the relevant provisions of the "Specifications for the Management of Drug Operations"，According to Article 25 of the Measures for Flight Inspection of Drugs and Medical Device，The Provincial Bureau decided to recover the company's "Certificate of Quality Management of Drug Operations" (Certificate Number: A-LN14-042)。

 

  At the same time，It is required that the company should comprehensively rectify the existing problems and quality hidden dangers，Establish and improve the quality management system，Make sure to operate in accordance with regulations。