Natural products company to accept GMP, GEP audit
Release time:
2020-07-22
Natural Products Company Accepted GMP and GEP Review
News 12# November 16 -19 , Tianjin Jianfeng Natural Products Company Accepted GMP and GEP Double Review.
NSF Senior technical experts in the United States through in-depth analysis and understanding of the regulations, after a year of preparation, the requirements for GMP registration have been comprehensively upgraded and officially released and implemented in 2019 . This upgrade and revision is mainly aimed at manufacturers of dietary supplements and their raw materials to comply with 21 CFR PART 111 "current regulations on the manufacture, packaging, labeling and storage of dietary supplements". the new version adds food safety control (21 CFR PART 117 "human food preventive control " ) on the basis of cGMP , mainly reflected in the corrective and preventive measures, supplier qualification and food safety and other three aspects. GMP comprehensive upgrade can make natural products companies more in line with the requirements of the new standards, respond to the market, improve business competitiveness. The new GMP certificate also adds the words "meets FSMA" ( 21 CFR PART 117 ) and "cGMP" ( 21 CFR PART 111 ), which indicates that natural products companies meet the quality and safety requirements of FDA for dietary supplements.
Since the new version of GMP was officially issued in 4 this year, all functional departments of the natural products company have started to study the documents and carry out internal rectification according to the requirements of the documents. in early 12 , GMP internal audit was conducted. all departments worked together, supervised and reviewed each other, from the scene to the documents, and tried to do every detail well.
This audit is stricter and more rigorous than before. The presiding audit is also accompanied by supervision. They come from Shanghai Hebang Certification Co., Ltd. under the NSF certification organization. The 4 -day audit will not only take warehouses, production workshops and laboratories as the main on-site audit sites, but also conduct document audit. At the same time, the audit of "plant extract quality supplier GEP" was also completed by the authoritative NSF certification organization.
audit experts give true, accurate and objective evaluation according to each audited clause, put forward guidance and suggestions, and decompose each clause more carefully and rigorously, so as to have laws to follow and evidence to check. Natural products companies will also carry out rectification and upgrading according to the opinions put forward by experts to further ensure the safety of products. (Mu Ruixin)
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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