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
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
07-22
Peak International Trade was rated as "excellent delivery warehouse" by the big business"
On April 12, the 2019 Dalian Commodity Exchange Industrial Products Delivery Work Summary Meeting was held in Dalian. Jianfeng International Trading Company was rated as "2018 (Industrial Products) Excellent Delivery Warehouse" and Ruan Weihang, an employee of the International Trading Company, was rated as "2018 (Industrial Products) Excellent Futures Specialist in Designated Delivery Warehouse". The delivery link is the bridge link between the futures and cash markets, an important area of risk prevention and control in the futures market, and a strong guarantee for the smooth operation and function of the market. Since obtaining the qualification of PVC delivery warehouse in 2009, the chemical warehousing and logistics business of international trading company has developed steadily. In terms of management, the international trading company strictly follows the various systems of the Dalian Commodity Exchange to implement warehouse-in and warehouse-in management. The management level has been improved year by year. Broken packages have been handled on the spot, and the loss of goods has been greatly reduced. The management goal of daily clearing has been achieved, and standardized operations have been achieved; in terms of business marketing, the futures business has driven the gradual development and growth of the spot business, futures varieties have developed from a single PVC variety to four varieties of PVC, PP, PE and plywood. The business volume has increased year by year and has exceeded 500000 tons. The operation volume can exceed 2500 tons/day; In terms of customer service, from zero experience in futures business to now, customer reputation has increased year by year, and customer complaints have gradually decreased. The annual excellent delivery warehouse of the judges is the full affirmation of Dalian Commodity Exchange on the functions of international trading companies, market satisfaction, futures management level and standardization of warehouse daily management. Lou Chunming, general manager of the international trading company, said that the international trading company will implement
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
07-30
Peak Cement Won the Bid for National Key Project Daye Peak Becomes Huang-Huang Railway Supplier
On March 19, Daye Jianfeng Cement Company officially received a notice from China Railway Construction Material Collection Center that the company was shortlisted for the new Huang (Mei) Huang (Zhou) railway project in the Hubei section of the Shanghai-Chengdu high-speed railway along the Yangtze River in the second place, and obtained the right to supply the 6th package of cement. This is the first stick undertaken by Daye Jianfeng in 2019, and it is also the second time to enter the high-speed rail project after the Wu (Han) Jiu (Jiang) high-speed rail. The Huanghuang high-speed railway is a component of the "eight vertical and eight horizontal" high-speed railway network in the "National Medium and Long-term Railway Network Plan". It is a component of the Wuhan-Hangzhou and Beijing-Hong Kong-Kowloon high-speed railway network. It has a total length of 125 kilometers and a design speed of 350 kilometers per hour. It will start construction at the end of 2018. It will be opened to traffic in 2021. In addition to the characteristics of large demand for high-speed railway and highway projects, the project time span is long and the product quality requirements are high, especially the high-speed railway project has extremely strict requirements on the alkali content of cement. After participating in the bidding, Yuan Xianming, executive deputy general manager of Daye Peak, organized production, quality control, procurement and other relevant departments for many times to carry out tests on the production of low-alkali cement and adjust the proportion of raw materials. The quality control department also sent samples to the provincial professional inspection department for comparative inspection to ensure product stability. The marketing department carefully checked the details of the tender, strictly checked and repeatedly deduced the bid price. Finally, with the full cooperation of all departments, the successful bidding was passed, finalist Huang-Huang high-speed rail project. It is understood that as the country continues to increase investment in infrastructure transportation construction, daye peak adjusted its work direction at the end of 2018, requiring marketing work in 2019 to focus on key projects.
2020
07-31
Daye Peak Opens "Standard Year"
After the 2019 overhaul ended in early March, Daye Jianfeng Cement Company immediately launched the "Standard Year" activity to carry out standardized rectification in view of a series of defects and problems in the daily management process. The goal of the "Standard Year" activity is to target specific issues that affect employees' work efficiency and safe and environmentally friendly production. Through the formulation of institutionalized work standards, further standardize employees' various operations, improve operational efficiency, and improve grassroots management execution, so as to achieve The purpose of improving the company's image, reducing costs, improving efficiency, and increasing benefits. In order to ensure the smooth progress of the activities, daye peak has set up a promotion team headed by general manager Zhang fengliang to be responsible for the overall promotion of the "standard year" activities, mainly including revising the activity plan, summarizing the standardized implementation standards of various departments, implementing the plan, supervising the implementation progress, evaluating the implementation effect, collecting suggestions and opinions in the implementation process, etc. Based on the foundation, aiming at the details and solving problems is a major feature of Daye peak's "standard year" activity. For example, the "Flange Sealing Operation Standard", which is currently being tried out, not only puts forward standardization requirements for such a "trivial matter" in equipment management as flange sealing, but also attaches "model" photos to make it clear to mechanics What should be done and what should be done. However, this "small standard" aims at three problems: leakage at the production site, extensive mechanic work and waste of materials. Once it becomes the behavior habit of employees, the hygiene and cost control at the production site are bound to be improved. It is understood that Daye peak "standard year" activities plan to continue for three years to promote, activities
2020
07-22
Daye Peak Opens "Standard Year"
After the 2019 overhaul ended in early March, Daye Jianfeng Cement Company immediately launched the "Standard Year" activity to carry out standardized rectification in view of a series of defects and problems in the daily management process. The goal of the "Standard Year" activity is to target specific issues that affect employees' work efficiency and safe and environmentally friendly production. Through the formulation of institutionalized work standards, further standardize employees' various operations, improve operational efficiency, and improve grassroots management execution, so as to achieve The purpose of improving the company's image, reducing costs, improving efficiency, and increasing benefits. In order to ensure the smooth progress of the activities, daye peak has set up a promotion team headed by general manager Zhang fengliang to be responsible for the overall promotion of the "standard year" activities, mainly including revising the activity plan, summarizing the standardized implementation standards of various departments, implementing the plan, supervising the implementation progress, evaluating the implementation effect, collecting suggestions and opinions in the implementation process, etc. Based on the foundation, aiming at the details and solving problems is a major feature of Daye peak's "standard year" activity. For example, the "Flange Sealing Operation Standard", which is currently being tried out, not only puts forward standardization requirements for such a "trivial matter" in equipment management as flange sealing, but also attaches "model" photos to make it clear to mechanics What should be done and what should be done. However, this "small standard" aims at three problems: leakage at the production site, extensive mechanic work and waste of materials. Once it becomes the behavior habit of employees, the hygiene and cost control at the production site are bound to be improved. It is understood that Daye peak "standard year" activities plan to continue for three years to promote, activities
2020
07-31