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
Recently, it was learned from the competent department that the "ERP/MES full-process informatization" project of Jianfeng Pharmaceutical Company has been included in the list of key projects of "integration of industrialization and industrialization" in Jinhua City, and has now entered the publicity period. In order to speed up the in-depth integration of informatization and industrialization, according to the evaluation criteria in Jinhua City's "Several Opinions on Accelerating Informatization Construction" and "Jinhua City Informatization and Industrialization Integration Key Project Management Measures", 148 projects were included in 2017 Jinhua City's "Integration of Industrialization and Industrialization" key projects. The "ERP/MES Full Process Informatization" project of Jianfeng Pharmaceutical Co., Ltd. was finally included in the list after being recommended, material reviewed and expert reviewed by Jinhua Economic and Information Committee. The ERP-level subsystems of ERP/MES full-process informatization project include sales system, procurement system, MRP system, GMPQbD system, connecting UFIDA financial software and HR system. MES-level subsystems include industrial data acquisition and monitoring system, GAMP/MES system, eBPR (electronic batch production record system), cGMP quality assurance system, QC/eBTR(QC process and electronic batch inspection record system), LIMS system, etc. After the construction is completed, the visualization of drug production process and the collection and integration of industrial data will be realized. Realize the electronization of drug production process parameters, electronic batch production and inspection records; the realization of big data integration of industrial data and information will also be in line with the regulatory concept of GMP data integrity and quality traceability to the greatest extent. The establishment of a unified enterprise information platform will eliminate information islands and realize data one.
2020
07-31
The company's first-half profit record high
According to the 15th meeting of the ninth board of directors of the company on August 25, in the first half of 2017, the company achieved a net profit of 240.5357 million yuan, the highest level in half a year's history. In the first half of 2017, the company focused on the general work policy of "grasping trends, precise development, strengthening management, and improving efficiency", grasping the opportunities brought by economic structure optimization and industrial upgrading, strengthening lean production and management improvement internally, and actively exploring externally Develop new opportunities and continue to promote the "three reductions and three improvements" work. Through the joint efforts of all employees of the company, the best semi-annual performance in history has been achieved. As of the end of June 2017, the company's total assets were 4.226 billion yuan and net assets were 2.511 billion yuan; the company achieved total operating income of 1,305.9327 million yuan, an increase of 18.42 percent over the same period last year, and net profit attributable to owners of the parent company was 240.5357 million yuan, an increase of 132.11 percent over the same period last year. Earnings per share are 0.7 yuan. In the second half of the year, the company will continue to focus on the annual business plan, carry out in-depth work of "three reductions and three improvements", further do a good job in internal control, prevent business risks, and further do a good job in safety and environmental protection. we will further develop and improve the complementary relatively diversified main business structure and constantly enhance the company's core competitiveness. The 15th meeting of the 9th board of directors held on August 25 was presided over by Jiang Xiaomeng, chairman of the group company. Four proposals and reports including the 2017 semi annual report and the proposal on the change of the company's accounting policy were deliberated and passed. on the same day, the 12th meeting of the eighth board of supervisors was held,
2020
07-31
General Manager Yu Jianhong to Yunnan Peak to Guide Work
On August 23, Yu Jianhong, general manager of the group company, went to Yunnan Jianfeng cement company for investigation and guidance, and put forward requirements for the key work in the last few months of this year. At the peak of Yunnan Province, Yu Jianhong went deep into the production site to learn more about the current production and operation situation, and convened the middle-level and above management backbones to have in-depth exchanges and discussions with everyone on the problems existing in work efficiency changes, personnel stability, current production and management after the implementation of post optimization and re-organization. Since the beginning of this year, Yunnan's peak production and sales volume, profits and various technological and technical indicators have been relatively ideal. The kiln output in April has also reached the best level since it was put into production. The development and maintenance of the market, the environmental management of the factory area, and the professional quality and mental state of cadres and workers have also been greatly improved. While fully affirming the above achievements, Yu Jianhong pointed out that as the homogenization of the cement market becomes more and more serious, the market changes faster and faster. If we can't recognize the situation and seize the opportunity, enterprises will face more and more problems. In this case, the management backbone should give full play to the role of the backbone, quickly change the management concept, and strive to improve the competitiveness of enterprises. In view of the focus of work in the last four months of this year, Yu Jianhong put forward the following requirements for Yunnan Jianfeng: break the inherent concept of post functions and responsibilities, set up posts and organizational structures around logistics, people flow and capital flow, and cultivate and forge a team that can fight well. To further implement the training of job skills and quality, managers should take the lead in strengthening their own learning and formulate annual, monthly and weekly training plans, through the combination of internal and external training, theory and practice.
2020
07-30
General Manager Yu Jianhong to Yunnan Peak to Guide Work
On August 23, Yu Jianhong, general manager of the group company, went to Yunnan Jianfeng cement company for investigation and guidance, and put forward requirements for the key work in the last few months of this year. At the peak of Yunnan Province, Yu Jianhong went deep into the production site to learn more about the current production and operation situation, and convened the middle-level and above management backbones to have in-depth exchanges and discussions with everyone on the problems existing in work efficiency changes, personnel stability, current production and management after the implementation of post optimization and re-organization. Since the beginning of this year, Yunnan's peak production and sales volume, profits and various technological and technical indicators have been relatively ideal. The kiln output in April has also reached the best level since it was put into production. The development and maintenance of the market, the environmental management of the factory area, and the professional quality and mental state of cadres and workers have also been greatly improved. While fully affirming the above achievements, Yu Jianhong pointed out that as the homogenization of the cement market becomes more and more serious, the market changes faster and faster. If we can't recognize the situation and seize the opportunity, enterprises will face more and more problems. In this case, the management backbone should give full play to the role of the backbone, quickly change the management concept, and strive to improve the competitiveness of enterprises. In view of the focus of work in the last four months of this year, Yu Jianhong put forward the following requirements for Yunnan Jianfeng: break the inherent concept of post functions and responsibilities, set up posts and organizational structures around logistics, people flow and capital flow, and cultivate and forge a team that can fight well. To further implement the training of job skills and quality, managers should take the lead in strengthening their own learning and formulate annual, monthly and weekly training plans, through the combination of internal and external training, theory and practice.
2020
07-31
Spike Pharmaceuticals set out to explore a new sales model
Agency and Terminal Link Production and Chain Cooperation Spike Pharmaceuticals to Explore New Sales Models From August 16 to 21, the 2017 China Pharmaceutical Retail Industry Information Conference (hereinafter referred to as "Xipu Conference") with the theme of "Building a Blueprint-Market Awakening Focusing on Demand" was held in Boao, Hainan. Huang Jinlong, deputy general manager of the group company and general manager of the pharmaceutical company, and relevant leaders of Spike Health, pharmaceutical sales company and Spike Pharma pharmacy were invited to attend the event, to create a new sales model "road". This year coincides with the 10th anniversary of the Western Conference. More than 1200 mainstream chain pharmacies, more than 800 brand pharmaceutical industries, more than 100 cross-border affiliated institutions, more than 130 top domestic and foreign capital institutions, more than 60 representatives of authoritative media, and authoritative experts in the industry, with nearly 4000 people gathered in Boao. The meeting combed the context of the pharmaceutical retail industry in the past ten years, discussed the development of the industry in the new decade, and built a new blueprint for the industry. During the meeting, Huang Jinlong led the peak participants to have in-depth exchanges with the organizers of the conference and industry experts on issues such as the impact of national policies such as the brand strategy of enterprises, the role of brand enterprises in the industry, medical reform, prescription outflow, etc. on the original sales mode of pharmaceutical enterprises. He also had extensive contact with pharmaceutical counterparts and terminal chains, listened to front-line sales experience, collected relevant information on terminal chains, and collected market trends of the top 100 chains. In the past ten years, the scale of drug retail sales in China has increased from 143 billion yuan to 337.7 billion yuan, and the chain rate has increased from 35.3 percent to 49.4 percent.
2020
07-31
General Manager Yu Jianhong to Yunnan Peak to Guide Work
On August 23, Yu Jianhong, general manager of the group company, went to Yunnan Jianfeng cement company for investigation and guidance, and put forward requirements for the key work in the last few months of this year. At the peak of Yunnan Province, Yu Jianhong went deep into the production site to learn more about the current production and operation situation, and convened the middle-level and above management backbones to have in-depth exchanges and discussions with everyone on the problems existing in work efficiency changes, personnel stability, current production and management after the implementation of post optimization and re-organization. Since the beginning of this year, Yunnan's peak production and sales volume, profits and various technological and technical indicators have been relatively ideal. The kiln output in April has also reached the best level since it was put into production. The development and maintenance of the market, the environmental management of the factory area, and the professional quality and mental state of cadres and workers have also been greatly improved. While fully affirming the above achievements, Yu Jianhong pointed out that as the homogenization of the cement market becomes more and more serious, the market changes faster and faster. If we can't recognize the situation and seize the opportunity, enterprises will face more and more problems. In this case, the management backbone should give full play to the role of the backbone, quickly change the management concept, and strive to improve the competitiveness of enterprises. In view of the focus of work in the last four months of this year, Yu Jianhong put forward the following requirements for Yunnan Jianfeng: break the inherent concept of post functions and responsibilities, set up posts and organizational structures around logistics, people flow and capital flow, and cultivate and forge a team that can fight well. To further implement the training of job skills and quality, managers should take the lead in strengthening their own learning and formulate annual, monthly and weekly training plans, through the combination of internal and external training, theory and practice.
2020
07-31