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[ Focus on Chemical Machinery Equipment Network ] In the daily production and operation of pharmaceutical factories, pharmaceutical equipment is an important part and one of the six quality sections of the FDA.
However, the equipment section has always been ignored by pharmaceutical companies, such as selection Insufficient consideration, inadequate design, inadequate confirmation, and inadequate daily operation and maintenance often occur.
Once equipment performance fails to meet regulatory requirements, it is easy to bring hidden dangers to drug quality and safety
.
Medicines are special products related to human health and safety, which also reminds pharmaceutical companies that they need to attach great importance to the maintenance and management of pharmaceutical equipment to ensure the function and service life of the equipment
.
Chemical machinery and equipment network hotspots pay attention to chemical machinery and pharmaceutical equipmentHowever, the equipment section has always been ignored by pharmaceutical companies, such as selection Insufficient consideration, inadequate design, inadequate confirmation, and inadequate daily operation and maintenance often occur.
Once equipment performance fails to meet regulatory requirements, it is easy to bring hidden dangers to drug quality and safety
.
Medicines are special products related to human health and safety, which also reminds pharmaceutical companies that they need to attach great importance to the maintenance and management of pharmaceutical equipment to ensure the function and service life of the equipment
.
There are many types of pharmaceutical equipment, including API equipment and machinery, preparation machinery, pharmaceutical crushing machinery, decoction pieces machinery, pharmaceutical water equipment, pharmaceutical packaging machinery, drug testing equipment, and other pharmaceutical machinery and equipment (pharmaceutical auxiliary equipment), etc.
The equipment in the pharmaceutical factory is responsible for their own major production missions, coupled with the short repair cycle, which makes the pharmaceutical factory have a greater challenge in the management of the equipment.
At present, the management mode of many domestic pharmaceutical companies is still relatively outdated.
The initiative of equipment management is low, and maintenance management is often performed after equipment problems occur, which causes high maintenance costs and also affects the stable operation of production
.
API equipmentThe equipment in the pharmaceutical factory is responsible for their own major production missions, coupled with the short repair cycle, which makes the pharmaceutical factory have a greater challenge in the management of the equipment.
At present, the management mode of many domestic pharmaceutical companies is still relatively outdated.
The initiative of equipment management is low, and maintenance management is often performed after equipment problems occur, which causes high maintenance costs and also affects the stable operation of production
.
The industry pointed out that there are some prominent problems in the management and maintenance of pharmaceutical equipment in pharmaceutical companies, which can be roughly classified into three aspects: First, the lack of investment in information technology, although in recent years pharmaceutical companies have begun to pay attention to equipment management and actively record Problems such as the basic parameters of the equipment, but in the actual management process, there are often situations such as the lack of specific information on the equipment and the slow provision of maintenance data, which makes the maintenance and post-modification of the equipment difficult to proceed smoothly, which directly brings hidden dangers to the quality of the medicine
.
.
Second, pharmaceutical equipment is a high-tech, highly specialized, and complex industry.
Because some equipment does not have specific maintenance standards, and some companies do not pay attention to equipment management, they lack the willingness to formulate equipment maintenance standards.
The maintenance of many equipment is difficult to implement, and many companies still use the traditional management method of "repair if an accident occurs, and nothing is ignored"
.
Because some equipment does not have specific maintenance standards, and some companies do not pay attention to equipment management, they lack the willingness to formulate equipment maintenance standards.
The maintenance of many equipment is difficult to implement, and many companies still use the traditional management method of "repair if an accident occurs, and nothing is ignored"
.
Third, pharmaceutical companies lack equipment management and maintenance personnel and teams with high professional quality, coupled with the low level of professional skills of operators, and lack of a self-contained equipment maintenance training system, which impedes equipment maintenance work and also poses potential safety hazards to equipment.
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In response to the above problems, pharmaceutical companies urgently need to change their management concepts and models, strengthen the maintenance of pharmaceutical equipment, and ensure drug quality and safety
.
For example, it is possible to establish a sound and complete information collection system for pharmaceutical equipment, to actively understand foreign new technologies and concepts, and to strengthen the good control of equipment parameters using computers and other technologies to help improve the quality of medicines and the efficiency of medicine production
.
At the same time, the quality of employees is directly related to the quality of equipment.
Pharmaceutical companies need to pay attention to the training and introduction of professional talents, strengthen the technical training of maintenance and professional management personnel, and improve their comprehensive quality and maintenance management technical level
.
In addition, pharmaceutical companies also need to strengthen the inspection of pharmaceutical equipment, determine the repair time, grasp the types of failures, etc.
, and actively take targeted measures for maintenance and management to ensure the quality of drug production
.
.
For example, it is possible to establish a sound and complete information collection system for pharmaceutical equipment, to actively understand foreign new technologies and concepts, and to strengthen the good control of equipment parameters using computers and other technologies to help improve the quality of medicines and the efficiency of medicine production
.
At the same time, the quality of employees is directly related to the quality of equipment.
Pharmaceutical companies need to pay attention to the training and introduction of professional talents, strengthen the technical training of maintenance and professional management personnel, and improve their comprehensive quality and maintenance management technical level
.
In addition, pharmaceutical companies also need to strengthen the inspection of pharmaceutical equipment, determine the repair time, grasp the types of failures, etc.
, and actively take targeted measures for maintenance and management to ensure the quality of drug production
.
Original title: Three major problems in the management and maintenance of pharmaceutical equipment in pharmaceutical factories