Interim Measures for Safety Production Management in the Pharmaceutical Industry

Chapter 1 General Provisions Article 1 In order to strengthen the management of production safety, protect the safety and health of workers during the production process, maintain the security of national property, and promote the development of the pharmaceutical industry, according to the "People's Revolution of the People's Republic of China and the These measures are specially formulated in accordance with the Constitution of the People's Republic of China and relevant state regulations. Article 2 All units and employees engaged in pharmaceutical enterprises and institutions must abide by these Measures. Article 3 The policy of “safety first, prevention first” must be implemented in production and business activities. When planning, arranging, inspecting, summarizing, and evaluating production work, safety production should be planned, arranged, inspected, summarized, and evaluated at the same time. Work. Rely on the masses, technological progress and scientific management to achieve safe and civilized production. Chapter 2 Responsibilities Article 4 Safety responsibilities of pharmaceutical authorities at all levels

1. Implement national guidelines, policies, regulations and relevant provisions on occupational safety and health, and formulate specific policies and methods for the pharmaceutical industry;< /p>

2. Guide the safety production work in the industry, organize the exchange of safety production information and the promotion of typical experience;

3. Organize safety technology training in the industry;

4. Participate in the investigation, handling, summary and reporting of major accidents. Report the safety production situation in the pharmaceutical industry;

5. Organize safety production inspections in the industry, supervise and coordinate the rectification of major hidden dangers;

6. Responsible for new construction, reconstruction, expansion, technological transformation, Review and acceptance of labor safety and health facilities in technology introduction projects;

7. Commend and reward advanced collectives and individuals in safe production. Article 5 Safety responsibilities of pharmaceutical enterprises and public institutions:

1. Implement labor protection laws and regulations and relevant national regulations, and formulate and strictly implement production safety systems based on the conditions of the unit;

2. Make plans to improve working conditions and prepare and organize the implementation of safety technical measures plans;

3. Regularly report labor protection work to the Workers’ Congress;

4. Organize safety education and Safety technology training;

5. Organize safety inspections, implement hidden danger rectification, and promptly resolve and report major hidden dangers;

6. Organize accident investigation, handling and reporting;

< p>7. Recognize and reward advanced collectives and individuals in safety production. Article 6: Pharmaceutical authorities at all levels and enterprises and institutions must set up corresponding safety technical institutions or full-time personnel. Article 7: The first administrative person in charge of pharmaceutical authorities at all levels and enterprises and institutions shall be fully responsible for the safety production of their own systems and units. The deputies shall be responsible for the safety work within their respective business scopes, and each functional department shall bear specific responsibilities. Article 8 Safety Responsibilities of Employees

1. Employees must perform safety responsibilities, abide by labor disciplines, implement safe operating procedures and safety systems, and correctly use production equipment, protective facilities and labor protection supplies.

2. Employees have the right to refuse illegal orders, oppose risky operations, and stop others from illegal operations. They have the right to criticize, report and accuse leaders who ignore the safety and health of employees. Chapter 3 Places and Facilities Article 9 Labor places and facilities must comply with relevant regulations such as "Factory Safety and Health Regulations", "Hygiene Standards for Design of Industrial Enterprises" and "Code for Fire Protection Design of Buildings". Article 10 Engineering projects that are newly built, renovated, technologically transformed or introduced with technology must have labor safety and health facilities and be designed, constructed and put into operation at the same time as the main project. Article 11: The design and manufacture of new products and new equipment, the use of new processes, new technologies and imported equipment and technologies must comply with the provisions of national labor protection laws, standards and technical specifications. Article 12 When producing and using dangerous goods such as flammable, explosive, highly toxic (including highly toxic traditional Chinese medicines and anesthetics), volatile, highly corrosive, radioactive elements, etc., the relevant national regulations and safety regulations must be implemented, and the production environment must be regularly monitored. Toxic and harmful substances in the environment must be treated if they exceed the deadline specified by the national standards. Article 13: Work places and passages must be kept clean and tidy, and protective facilities, lighting and obvious signs must be installed in accordance with regulations. Article 14 In the workplace, relevant national standards must be met for high temperature, low temperature, humidity, radiation, mercury, static electricity, noise and dust (including chemical dust and silica dust). Article 15 When working in dangerous places with poor air circulation such as containers, pipes, caves, sewers, etc., reliable safety precautions must be taken, and there must be dedicated supervision and approval procedures. Article 16 Warehousing management must comply with the provisions of the State Council’s Regulations on the Safety Management of Hazardous Chemicals and the Warehouse Fire Safety Management Rules.

Article 17 Containers, tanks, towers, kettles, pipelines and other equipment must be inspected and maintained regularly to prevent leaks, leaks, and leaks. For equipment with flammable and explosive hazards, signal alarms, explosion-proof pressure relief, insurance control and other facilities should be installed as required to ensure good performance, sensitivity and reliability. All types of equipment must not be over-temperature, over-pressure, over-speed, over-load, or malfunctioning. Article 18: Ensure the normal operation of various safety and health facilities. Any improvements, misappropriations, demolitions or installations must be approved by the responsible safety director or manager. Article 19 The design, manufacture, installation, use, inspection, repair and modification of boilers (including hot water boilers) and pressure vessels shall be carried out in accordance with the "Safety Supervision Regulations for Steam Boilers", "Safety Technical Supervision Regulations for Hot Water Boilers" and "Pressure Container Safety Supervision Regulations shall be implemented. Article 20 Electrical equipment and circuits must comply with the provisions of the Electrical Industry Safety Work Regulations.