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    Home > Active Ingredient News > Drugs Articles > Under the future drug quality management system, where should equipment maintenance personnel go?

    Under the future drug quality management system, where should equipment maintenance personnel go?

    • Last Update: 2019-12-11
    • Source: Internet
    • Author: User
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    [pharmaceutical network market analysis] pharmaceutical enterprises' quality and production departments play an important role in pharmaceutical production In recent years, with more and more strict requirements for drug quality, the quality and production departments of pharmaceutical enterprises should pay more attention to it So, what is the status of production equipment management, maintenance and repair personnel for the whole system? Under the future quality management system, where should these personnel go? Literally, the production equipment management, maintenance and repair personnel are the personnel specialized in the management, maintenance and repair of production equipment Once the equipment breaks down, these personnel are required to maintain it However, according to many industry insiders, the company's equipment maintenance personnel are not equipped enough to stop to learn equipment operation and process, which makes the maintenance equipment appear to be very laborious; some people also say that the company's equipment maintenance personnel do not have the high authority of the equipment, cannot deeply understand the equipment process, and maintenance is difficult The industry points out that the position of equipment maintenance management personnel should be improved, including the right to speak and personnel allocation In recent years, with the increasing degree of automation and specialization, the production efficiency of the equipment is constantly improving, which will also make people dependent It is based on the equipment parameters slowly, but the parameters of the equipment feedback and the stability of the equipment also need professional personnel to manage and control "To put it simply, people were in charge of people before, and people were in charge of equipment later." It is believed that from the perspective of equipment alone, engineering maintenance personnel should have high authority to modify the internal parameters of the equipment Otherwise, once there is a problem with the equipment, it is difficult to maintain without authority If they are not familiar with the process and operation steps of the equipment, they cannot have a deep understanding of the equipment and maintenance equipment In this regard, people who have done equipment operation and maintenance for many years said that they very much agree with this view "I have done equipment operation and maintenance for many years, during which I have also done projects and verification Some companies have a good strategy, with high authority in the engineering department, and can operate and maintain necessary equipment when necessary But some companies have high authority in the production department and low authority in the project, which increases the difficulty of equipment management and maintenance, and also wastes the time of both parties " Regardless of the company's considerations, the adverse consequences of this mistrusted cooperation will gradually increase, the person said The author believes that under the future drug quality management system, drug quality supervision will only become more and more strict, and the status of equipment maintenance personnel will be further improved, while also facing several challenges First, the equipment personnel need to understand the process The equipment personnel shall master the technical characteristics, system structure, process, etc of the equipment, so as to take measures for possible faults and maintain the equipment in time Secondly, the equipment personnel should be more professional and need more training Some insiders have said that many equipment personnel and even senior managers will make some low-level mistakes in their work, which is mainly caused by the low professionalism Therefore, it is very important to strengthen the training and learning and improve the professionalism of the equipment personnel The equipment personnel should have the professional knowledge and technology of the equipment, as well as good management and relearning ability and the ability to summarize experience Third, the equipment personnel should have high professional quality With the increasingly strict drug quality supervision, the equipment management personnel need to have a high quality in the maintenance and inspection work, strive for perfection, be careful and meticulous, and can not hold the attitude of "can be used, can be done" and perfunctory.
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