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
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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