How to strictly control the quality and safety of drugs?

[Pharmaceutical Network Technical Articles] Medicines are special commodities, and their quality affects the health of the human body
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As a drug manufacturer, it is necessary to strictly control the quality and safety of drugs, standardize the production process, and ensure that China's drugs meet the national quality standards, so as to ensure the safety of public medication
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At this stage, domestic pharmaceutical companies have generally recognized the importance of GMP management in the "Good Manufacturing Practice for Drugs" and have widely used this management model
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 How to strictly control the quality and safety of drugs? It is very important to do a good job in the management of pharmaceutical equipment (Photo source: Pharmaceutical Network) To implement GMP management in pharmaceutical companies, it is necessary to strictly comply with national standards in terms of personnel, materials, equipment, and quality control
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Among them, equipment management is closely related to drug production
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In the process of producing and processing drugs, pharmaceutical companies not only need to strictly abide by the relevant standards of GMP management to produce and process drugs, but also need to scientifically and rationally apply and manage pharmaceutical equipment
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It is understood that verification is a new requirement put forward by GMP management to ensure the quality of drugs.
As the equipment management department, it is necessary to regularly verify the pharmaceutical production equipment to ensure that the equipment can meet the needs of pharmaceutical production
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 　　At the same time, after any technical transformation of pharmaceutical production equipment, the equipment should be reorganized and verified to ensure that it can meet the needs of pharmaceutical production
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 　　In addition, in the process of organizing the verification of pharmaceutical production equipment, it is also emphasized that the rationality and perfection of the verification scheme and verification content should be strengthened, and continuous supplementation should be made to enhance the accuracy of the verification of pharmaceutical production equipment
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 　　At present, the domestic pharmaceutical equipment market has a wide variety of equipment with complete specifications, which can basically meet the needs of pharmaceutical companies, especially small and medium-sized enterprises
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However, compared with large foreign pharmaceutical companies, the overall technical equipment level of domestic pharmaceutical companies is generally relatively low, the implementation of mechatronics of equipment is not high, and the degree of dependence on people in the production process of drugs is still relatively high.
The quality of medicines also varies
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 　　"In the pharmaceutical process, GMP management requires that the production of drugs be carried out in batches and the transfer of the process to be completed in a very short time
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However, some companies may still use pure mechanical and single-function pharmaceutical equipment, which makes it impossible to achieve In the case of the above requirements
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" said the person with the medicine machine
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 　　The author has learned that some pharmaceutical companies have previously had some of the inspection equipment and production equipment outdated and failed to meet the relevant requirements of the current GMP management, resulting in the withdrawal of the relevant product GMP certificate
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 　　In order for pharmaceutical equipment to better meet the needs of drug production, the industry believes that the elimination of backward technology equipment should be accelerated.
The degree of implementation of mechatronics in production equipment further liberates the hands of employees, improves production efficiency, and ensures the stability of the quality of the drugs produced
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 　　At the same time, the functions of the equipment should be expanded.
For example, in the monitoring and control functions of pharmaceutical equipment, the ability to analyze and deal with problems of the equipment should be continuously improved to better serve the pharmaceutical enterprises; another example, in the purification function of the equipment , the purification function is one of the very important functions in the GMP management function
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Purification in pharmaceutical equipment mainly includes two aspects: one is that the pharmaceutical equipment will not pollute the pharmaceutical environment and studio during the working process; Oil, dust and other pollution for purification
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In order to ensure that drugs are less affected by contamination, it is necessary to strengthen the control of the entire drug purification process, to ensure that the equipment is fully automated in the process of drug production and processing, and to realize the separation of man and machine in operation
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 　　It is worth mentioning that the maintenance and management of equipment is also a big homework
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The level of professional skills of maintenance personnel directly affects the service life of the equipment.
Therefore, it is very important to strengthen the training and assessment of personnel
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It is suggested in the industry to strengthen the training, improve the technical level of maintenance personnel, establish a stable maintenance team, and ensure the quality of maintenance
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At the same time, it can also pass the assessment to improve the work enthusiasm and professionalism of maintenance personnel
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