Intellectual property management is not simple
Release time:
2020-08-14
Intellectual Property Management is Not Simple
5# In May, I attended the third training course for enterprise internal auditors in Zhejiang Province and learned the foundation of enterprise standard management system, interpretation of intellectual property management standard text, compilation of management system documents, and implementation process of intellectual property standards.
, as a QA member of the pharmaceutical quality management department, at first I didn't think the correlation between intellectual property rights and quality management was very big, because for drug production, quality is the most important thing, GMP is what we should focus on learning, and we should take GMP as the criterion everywhere in our work to ensure good quality. But after this study, I have some preliminary ideas on how to integrate intellectual property into the quality department. For example, "confidentiality", although the quality management department is not as good as the core department of new drug research and development, once it enters the trial production stage, the quality management department will participate in it, and all kinds of relevant documents of drug production should be summarized to the quality management department, so confidentiality work is also very important for the quality management department. The QA department involves the most documents, including quality standards, supplier information, process procedures, post operation SOP , equipment list, floor plan, etc. The classified level of each type of document should be refined and stipulated in the document. In my opinion, in the process of establishing a new system, after formulating the principles and objectives, we should not only have an accurate understanding of the norms, but also proceed from reality and formulate them based on the actual situation of each department. Only in this way can we have operability. The intellectual property management system is not a completely independent management structure, it needs to be attached to the existing management system of the enterprise, make full use of the existing management system foundation, enhance the effectiveness and feasibility of the system operation, reduce the operation cost of the enterprise intellectual property management system, and improve the operation efficiency. After the establishment of
intellectual property management system, the next step is to implement it. In the process of implementation, we adopt the method of PDCA to ensure the continuous operation and continuous improvement of the intellectual property system. The cycle of PDCA is also called quality ring, which is the basic criterion in the quality management system. Our daily GMP management also follows this basic principle, in which P is planning, D is implemented or executed, C is checked, and A is effective. This is a dynamic management mode, which continuously discovers problems, raises problems, and then improves, make GMP management implement every link of production management. So the intellectual property management system can learn from the PDCA approach. The establishment of
intellectual property management system, the implementation of the process, the internal audit and external audit of the inspection and implementation results, corresponding to GMP management work is GMP self-inspection and GMP certification. Among them, the internal audit process is very similar to the GMP self-inspection process, and the production of various forms can be completely referenced. Our quality management department has a very detailed internal self-inspection management procedure of GMP on GMP self-inspection, which we can learn from in the intellectual property management system.
It is not an overnight thing to push forward the implementation of standards. It requires us to persevere and unswervingly to achieve results. It is the general trend for enterprises to implement standards. As an internal auditor, I have the responsibility to assist the company's intellectual property management department to establish an intellectual property management system, enhance the competitiveness of enterprises and create added value. (Lin Jianping)
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
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