North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. Safety Status Evaluation Report of Aoqide Factory
Time：2015-03-11
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1. Safety evaluation project name: North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. Safety Status Evaluation Report of Aoqide Factory
2. Introduction to the safety assessment project:
North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. Orchid Factory (hereinafter referred to as Orchid Factory), formerly known as North China Pharmaceutical Orchid Pharmaceutical Co., Ltd., was established on September 2, 2002, the legal representative is Wei Qingjie, The factory is located at No. 18 Yangzi Road, Economic and Technological Development Zone, Shijiazhuang City, with a registered capital of 10 million US dollars. The enterprise type is a Sino-foreign joint venture. It is a joint venture between North China Pharmaceutical Joint stock company and India Orchid Chemical & Pharmaceutical Ltd., one of the world's top ten pharmaceutical companies. The business scope is the production, sales, research and development of cephalosporin APIs and preparations.
North China Pharmaceutical Aoqide Pharmaceutical Co., Ltd. was absorbed and merged into a wholly state-owned factory by North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. on October 26, 2012, and is now renamed as North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. Aoqide Factory.
The Orchid factory adopts advanced pharmaceutical technology imported from India, and the product quality is in a leading position in China. The product quality meets the requirements of the Chinese Pharmacopoeia, the American Pharmacopoeia, and the British Pharmacopoeia.
The products of this factory are not classified as hazardous chemicals. The raw and auxiliary materials used in the production process include triethylamine, acetone, methanol, nitrogen, acetic acid, ethyl acetate, ethanol, dichloromethane, hydrochloric acid, caustic soda, sulfuric acid, activated carbon, Freon R22, tetrahydrofuran, acetonitrile, isopropanol, and ammonia. In addition, the production process also uses the method of rectifying methanol (Danger Regulation No.: 32058), ethanol (Danger Regulation No.: 32061), acetone (Danger Regulation No.: 31025), ethyl acetate (Danger Regulation No.: 32127) and other dangerous chemicals are recycled.
3. Safety evaluation project leader, technical leader, process control leader, evaluation report compiler, report auditor, safety evaluator, registered safety engineer, and technical expert involved in the evaluation:
Safety evaluation project leader: Gao Weili
Technical person in charge: Cao Shuhua
Person in charge of process control: Wang Lin
Evaluation Report Compilers: Xu Zhe, Sun Guang, Wang Ying
Report Reviewer: Zhou Junhong
Safety evaluators, registered safety engineers, and technical experts participating in the evaluation work: Gao Weili, Xu Zhe, Sun Guang, Wang Ying, Zhou Junhong, Cao Shuhua
4. List of personnel, time, and main tasks to carry out safety evaluation work on site, and evaluation report time:
In December 2014, North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. commissioned Hebei Huafei Technology Consulting Co., Ltd. to undertake the safety evaluation of the factory. Conduct safety evaluations on the company's production, storage and transportation equipment and public works, and sign a safety evaluation technical service contract.
This safety status evaluation is based on the company's surrounding relationships, general layout, production equipment, supporting public works and auxiliary facilities, safety management, etc. This safety status evaluation is mainly based on the checklist evaluation method. According to the current laws and regulations of the country, standards and norms are compared to identify non-conformities, so that enterprises can carry out rectification and improvement in a targeted manner. For dangerous and harmful factors with higher risk levels, risk assessment methods and major accident consequence simulation are used to quantitatively evaluate their risk level, providing a basis for enterprises to formulate emergency rescue plans and key prevention.
After solid work, the safety status evaluation report of this project was completed in January 2015.