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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)

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