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How to adapt equipment management to GMP management

by:Jinzong Machinery     2021-10-29
With the implementation of 'Good Manufacturing Practices for Pharmaceutical Production' (GMP) in pharmaceutical companies, higher requirements have been put forward for the management of various related departments; how to adapt to GMP management in the implementation process of pharmaceutical production is the relevant department The problem that must be solved is that equipment management has a close relationship with pharmaceutical production. However, because GMP management focuses on the management of pharmaceutical production quality, it does not have specific requirements for equipment management. Therefore, how to adapt equipment management to GMP management? Ensuring the smooth progress of pharmaceutical production is a problem that the equipment department must think about and solve. In the following, we will talk about the corresponding countermeasures of equipment management and GMP management from several aspects in combination with actual work. 1. The implementation of standard operating procedures (SOP) in equipment management    In the implementation of GMP management, a notable feature is: in actual work, the implementation of standard operating procedures (SOP) management, that is: in the drug production process, any The related work must be carried out in full accordance with the SOP, which not only improves work efficiency, but also avoids work errors due to human reasons and affects the quality of medicines. In equipment management, the implementation of SOP management can achieve the same effect. On the one hand, in the daily management of equipment, work methods can be standardized to facilitate tracking management. For example, the SOP of filling, collecting, summarizing, and analyzing various operating records of pharmaceutical production equipment is convenient for supervisors and production planning departments to review the entire plant. The operation status of equipment can be controlled to rationally arrange the production of medicines in the whole plant; the SOPization of equipment purchase application, purchase, unpacking, installation, commissioning, and acceptance can improve the rationality of equipment purchase, reduce risks, and strengthen equipment File management facilitates the tracking and management of equipment; on the other hand, during the production and operation of the equipment, the operation of workers can be regulated and the operating skills can be improved. The skill difference between small-scale production workers; the SOPization of equipment maintenance can improve the work efficiency of maintenance workers, reduce equipment downtime, and ensure the smooth progress of pharmaceutical production.   2. Strictly implement the large and medium repair plan of the equipment to ensure that the equipment is in good condition.    In order to ensure the smooth progress of the pharmaceutical production, the equipment must be in good condition. For equipment major and medium repair plans, it is necessary to negotiate with the production planning department and implement them. As the equipment management department, according to equipment operation records and equipment conditions, a reasonable and complete annual equipment major and medium repair plan should be formulated at the beginning of each year, and According to the maintenance plan, the procurement and processing of equipment spare parts should be done in advance to ensure the smooth implementation of the equipment large and medium repair plan. During the execution of the maintenance plan, if the plan cannot be implemented due to production tasks or other reasons, the equipment management department shall negotiate with the production planning department to reschedule the implementation time. 3. Gradually replace post-maintenance with pre-maintenance. At present, the maintenance of equipment in domestic pharmaceutical companies mainly focuses on post-maintenance, that is: repair work is carried out after the equipment fails, and the cost is that the production of medicines will be interrupted, and the batch of medicines will be more serious. Rework or scrap, this kind of maintenance method seriously threatens the quality of medicines. With the implementation of GMP management, the equipment management method based on post-maintenance can no longer meet the relevant requirements of GMP; in order to meet the requirements of GMP management, it is urgent to change the backward equipment management method based on post-maintenance. At present, the development of science and technology provides solid technical support for pre-maintenance instead of post-maintenance. The so-called pre-maintenance means that the condition of various parts of the equipment is monitored through certain technical means, and the occurrence of equipment failures can be found in advance. When the equipment failure has not occurred, take measures to eliminate the hidden troubles. The essential difference between pre-maintenance and post-maintenance is: pre-maintenance is active and can minimize losses; post-maintenance is passive and can only reduce losses. Therefore, by gradually replacing post-maintenance with advance maintenance in equipment management, equipment downtime can be effectively reduced, the smooth production of medicines can be ensured, production efficiency can be improved, and production costs can be reduced. As the equipment management department, in actual implementation, it can first monitor the status of the main equipment and linked production lines in the drug production process, carry out pre-maintenance, and then gradually extend it to all equipment.  4. Technical transformation of equipment to improve the level of mechatronics. 
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