Pharmaceutical companies through GSP certification
Release time:
2020-07-22
Pharmaceutical Company Passed GSP Certification Replacement
News 6# September 5 , Jinhua Pharmaceutical Company received the "Pharmaceutical Business Quality Management Standard Certification" certificate and the "Pharmaceutical Business License" sent by Zhejiang Food and Drug Administration, marking the successful completion of the license replacement and GSP certification inspection by the pharmaceutical company.
"Drug Business Quality Management Standard Certification" certification and "Drug Business License" renewal are carried out every five years. Pharmaceutical company passed the new version of GSP certification in 2014 , which expires in 8 this year and needs to reapply for renewal certification. On the third day of work after the Spring Festival holiday, the pharmaceutical company held a special meeting to mobilize and deploy, and formulated the implementation plan for the renewal and certification of drug GSP , which involved drug procurement, storage, sales, logistics, personnel and institutional files, Computer systems, quality management and other drug operations, designated the implementation department and responsible person, and set the completion time limit. At the same time, all departments are required to carry out self-examination and rectification according to GSP management standard, and zero tolerance for violation of GSP standard. The Quality Management Department lists the internal audit checklist of the quality management system, specifies the inspection results and responsible departments one by one according to the inspection contents corresponding to the items in Article GSP , carries out simulated inspection and acceptance on various departments and links, makes rectification and improvement on the places that do not meet the requirements, and sends the replacement application report to the provincial food and drug administration at the end of February 4 . On the morning of
5 6 , the GSP inspection team composed of three experts from Jinhua Drug Certification Center conducted a comprehensive inspection of the drug management and quality management of pharmaceutical companies according to the predetermined inspection plan. The experts were satisfied with the pharmaceutical company's GSP working software and hardware management work, affirmed the pharmaceutical company's efforts in implementing the GSP specification, and also pointed out the shortcomings. The pharmaceutical company formulated a rectification plan based on the rectification opinions put forward by the inspection team, implemented the responsible department and the responsible person, and immediately reported to the Jinhua Drug Certification Center after the rectification was in place, and successfully obtained the "Drug Business Quality Management Standard Certification" certificate and the "Drug Business License". (Fan Tufa)
More information
Publicity of Environmental Protection Acceptance for Completion of Kiln End Flue Gas Desulfurization Project of daye peak cement co., ltd. According to the requirements of the Interim Measures for Environmental Protection Acceptance for Completion of Construction Projects (No.4 [2017] of the State Environmental Regulations) issued by the Ministry of Environmental Protection, the environmental protection acceptance information of "Kiln End Flue Gas Desulfurization Project" of daye peak cement co., ltd. is now publicized. Basic Information of 1. Project Project Name: Kiln End Flue Gas Desulfurization Project Construction Unit: daye Jianfeng Cement Co., Ltd. Project Construction Location: Yongguang Village, Baoan Town, daye city, nature of the project in the existing plant area of daye Jianfeng Cement Co., Ltd.: The construction content of the technological transformation project is: This technological transformation project is mainly to build a wet desulfurization system for kiln end gas of the company's existing 4000t cement clinker production line, adopting limestone-gypsum wet flue gas desulfurization process. The project covers a total area of 500 m2, with a new construction area of about 450 m2. It mainly builds desulfurization complex building, flue gas system, SO2 absorption system, limestone powder conveying and limestone slurry preparation system, process water system, gypsum dehydration system and supporting pipelines. Power supply, water supply, compressed air and other public works rely on the existing plant. Total investment and environmental protection investment: the total investment of the project is 10.37 million yuan, all of which are environmental protection investment. The project was entrusted to Huangshi Yangtze River Environmental Engineering Design and Research Institute to carry out environmental impact assessment in September 2017. On November 16, 2017, Daye Municipal Environmental Protection Bureau issued a reply with YEHAN [2017] No. 354. Implementation of 2. environmental protection measures The scope of this acceptance is the flue gas desulfurization system and supporting facilities at the end of the kiln. (1) Exhaust gas pollution
2020
07-31
Spike New Drug Approved for Registration
On April 16, Jianfeng Pharmaceutical Company received the approval and issuance of Olopatadine Hydrochloride Eye Drops "Drug Registration Approval" (approval number: 2019S00296) approved by the State Drug Administration. Olopatadine hydrochloride eye drops is mainly used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments. At present, the product has been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)" and classified as Class B. According to the relevant data of IMS database, in 2018, the global sales of olopatadine hydrochloride eye drops were about 0.37 billion US dollars, and the sales in China were about 10.232 million US dollars. Spike Pharmaceuticals already has the corresponding production line, this time to obtain the registration approval, marking Spike Pharmaceuticals has the qualification to carry out the production and sales of olopatadine hydrochloride eye drops, will further enrich the product line of Spike Pharmaceuticals, help to enhance the competitiveness of the company's pharmaceutical business. (Xia Yingpin)
2020
07-31
Spike New Drug Approved for Registration
On April 16, Jianfeng Pharmaceutical Company received the approval and issuance of Olopatadine Hydrochloride Eye Drops "Drug Registration Approval" (approval number: 2019S00296) approved by the State Drug Administration. Olopatadine hydrochloride eye drops is mainly used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments. At present, the product has been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)" and classified as Class B. According to the relevant data of IMS database, in 2018, the global sales of olopatadine hydrochloride eye drops were about 0.37 billion US dollars, and the sales in China were about 10.232 million US dollars. Spike Pharmaceuticals already has the corresponding production line, this time to obtain the registration approval, marking Spike Pharmaceuticals has the qualification to carry out the production and sales of olopatadine hydrochloride eye drops, will further enrich the product line of Spike Pharmaceuticals, help to enhance the competitiveness of the company's pharmaceutical business. (Xia Yingpin)
2020
07-31
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