Dongying City Food and Drug Administration established risk profile for pharmaceutical companies

In order to strengthen the risk awareness of pharmaceutical companies, Dongying City Food and Drug Administration strengthened risk awareness, analyzed risk factors, and gradually established a risk prevention and control management system. While strengthening awareness of corporate risk responsibility and establishing credit rating, it also achieved The real-time dynamic monitoring of the whole process of drug production, distribution, and use in the city prevented major food and drug safety accidents.

In order to strengthen the awareness of corporate risk responsibility, the Bureau signed responsibilities and commitments with catering services and drug-and-arms enterprises, intensified the implementation of the drug regulatory authority system, urged enterprises to improve the quality traceability system, and fulfilled the responsibility of the company's first responsible person. The Bureau also implements annual, quarterly and special risk conferences and consultations systems, and conducts risk-based consultations with relevant companies at various levels and in different areas to determine prevention and control measures.

In order to ensure seamless and full coverage of the supervision, the Bureau has vigorously strengthened the construction of real-time drug monitoring systems and installed monitoring systems in more than 800 pharmaceutical companies throughout the city to achieve real-time dynamic monitoring of the whole process of drug production, distribution and use in the city. On this basis, the Bureau also strengthened the system construction of online auditing, counterfeit and inferior drug information inquiry, administrative examination and approval, and electronic supervision of essential drugs, established the early warning system for short-term drug and drug safety risks in Dongying City, and regularly sent food and drug warning information to further improve drug supervision and control. Risk warning and control mechanisms.

The Bureau has established risk management archives for more than 2,600 medical devices and pharmaceutical companies in the city. According to the registration of administrative licenses and daily regulatory records of the drug-related units, risk information is collected in a timely manner and assessed according to the scale of punishment, the severity of the circumstances, and the amount of subjective faults. The company's credit rating is divided into four levels A, B, C, and D and recorded in files. The bureau will appropriately reduce the frequency and items of daily supervision and inspection for the A-level drug-related units in the following year; establish warning mechanisms for B-level drug-related units, and take measures such as case review and individual interviews to strengthen supervision; for Class C and Class D Drug-related units, establish a disciplinary mechanism, as a key monitoring object, increase daily supervision and inspection efforts, increase product quality sampling frequency. For C- and D-grade pharmaceutical companies and business units that have records of multiple violations, the Bureau will revoke its production and business licenses according to law.

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