Recently, the Anhui Food and Drug Administration announced the “physical examination results” of 16 pharmaceutical companies, requiring “sub-health” enterprises with defects to pay close attention to “diagnosis and treatment”. It is normal for pharmaceutical companies to be found to be "ill". As the country pays more and more attention to drug safety, each drug manufacturer should also take this as a precept to actively respond to the inspection by the drug regulatory authorities.

Frequent refrigeration temperature is not up to standard

During the flight inspection process, Anhui Food and Drug Administration discovered that many companies have failed to reach the standard. For example, the qualifications of the Chinese medicine decoction pieces are not in compliance with the requirements, and the temperature and humidity storage conditions of the drugs are not met; the company keeps the normal temperature preservation drugs and the shady preservation drugs in the same stock, and does not meet the temperature control requirements of the normal temperature preservation drugs; the company does not refrigerate the car, keep warm The box carries out extreme weather verification, and fails to strictly check the temperature record of the refrigerated medicine in transit; the company's temperature and humidity automatic monitoring system backs up the data, the company's cold storage humidity exceeds the standard in some periods, and no effective measures are taken to regulate and so on.

In this regard, industry experts said that drugs are special commodities, and their storage temperature should meet relevant standards. Pharmaceutical companies and pharmacies should operate drugs in accordance with the "Good Manufacturing Practices" issued by the Drug Administration Law. "The acceptance of traditional Chinese medicine decoction pieces requires professional personnel to run, in order to ensure the temperature and humidity of the drug storage. For the preservation of drugs at room temperature and the preservation of drugs in the shade, they should be stored according to different temperature environments."

With the development of China's refrigeration technology and the advancement of technology, many refrigeration equipment and automatic monitoring systems are on the stage. Automation and intelligent technology bring great convenience to the monitoring and management of drugs in China, saving labor costs and energy, and reducing the output cost of enterprises. At the same time, however, the supervision of equipment and the regulation of necessary time periods are still indispensable. Therefore, while using the equipment, the pharmaceutical enterprises also need to carry out necessary monitoring, management and maintenance of the operation of the equipment to ensure the normal operation of the equipment and further ensure the safety of the medicine.

The performance of the testing equipment needs to be improved

It is understood that many pharmaceutical companies in the "physical examination" process, was found that part of the company's processes are not strictly in accordance with the requirements of the process regulations, the company's testing equipment does not meet the corresponding standards. For example, some companies' gas chromatographs, high performance liquid chromatographs, and atomic absorption spectrophotometers do not have the management authority and audit trail function, which is difficult to meet the detection requirements of drugs.

Taking meteorological chromatographs as an example, chromatographic detection methods and related technologies are constantly being popularized as food safety issues intensify. According to the research report, the total market size of the global chromatographic instrument market will reach 10.99 billion US dollars in 2022. Compared with 2017, the compound annual growth rate is 6.9%, which shows that the chromatograph market has considerable prospects.

However, industry insiders pointed out that the high-standard chromatographs on the market in China are mostly imported and expensive. Although the domestic equipment is cheap, it still needs to be improved in terms of functions, and the technology is difficult to meet the drug testing standards. Therefore, it is necessary for pharmaceutical companies to carry out research and development of new types of testing equipment, to create preferential and practical equipment, and to help China's pharmaceutical companies to develop better.

Employees should be clear about job responsibilities

The inspection also found that the data authenticity and reliability of some pharmaceutical companies were insufficient, the material management was not standardized, the post personnel were not familiar with the post business knowledge, and the training was not in place. The above phenomenon is the lack of responsibility of employees, which is caused by unclear job responsibilities.

The prosperity of a country and a nation always supports prosperity through cultural prosperity. Similarly, the development of a company is inseparable from the excellent corporate culture. In terms of employee management mechanism, pharmaceutical companies should establish effective methods to establish and improve the system guarantee system, activity organization system, incentive mechanism, and publicity and commendation mechanism to enhance employees' sense of responsibility, mission and honor, and fully mobilize employees' enthusiasm. , initiative and creativity, let each employee adhere to the integrity, truth-seeking and pragmatic spirit.

At the same time, talent is the fresh blood of the company's development. It is essential for the cultivation of professional talents. Many domestic pharmaceutical companies adopt the form of “collision” between technology and knowledge in the form of school-enterprise cooperation and enterprise technical talent exchange. They provide professional training for new employees or employees who are not familiar with the business, and improve their skills and professionalism to further ensure The stable development of pharmaceutical companies.

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