Evaluation of Safety Conditions of Hebei Anjian Chengyi Original Drugs and Preparation Series (Phase I)
Time：2014-08-14
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1. Name of safety assessment project:
Hebei Anjian Chengyi Pharmaceutical Technology Co., Ltd. National New Drug API Series Products and Preparation Series Industrialization Construction Project (Phase I Project) Safety Conditions Evaluation Report
2. Introduction to the safety assessment project:
The construction unit of this project is Hebei Anjian Chengyi Pharmaceutical Technology Co., Ltd. The company was established in October 2013 and is located in the biological industry zone of Zhaoxian Industrial Park (Zhaoxian Industrial Cluster Area). The registered capital is 3.30 million yuan, and the legal representative is Li Jiapei. The company's business scope is the development of medical technology, technology transfer, technical services, and technical consultation; the sale of pharmaceutical intermediates (except hazardous chemicals and state-controlled products) (all the above business scope laws, regulations and decisions of the State Council shall not be operated; matters requiring approval by other departments shall be operated after approval).
Hebei Anjian Chengyi Pharmaceutical Technology Co., Ltd. is located in the bio-industrial zone of Zhaoxian Industrial Park (Zhaoxian Industrial Cluster Area), covering an area of about 51 acres. The company plans to invest in the construction of a national-level new drug API series product and preparation series product industrialization project in the factory area (Phase I Project).
The main components of this project (Phase I) are:
The first phase of this project (API series products + preparation series products) will build a production workshop, warehouse, power workshop, and environmental protection facilities with an annual output of 100 tons of oxiracetam and 300 tons of ornithine aspartate. Construction of the annual production of allyl estradiol, levosupiride, nimodipine, olotadine hydrochloride tablets each 50 million tablets; annual production of entecavir capsules, tamoxin capsules each 40 million capsules; annual production of aspartate ornithine particles 50 million bags, acetyl glutamyl particles 30 million bags; annual production of levofloxacin hydrochloride eye drops 50 million bottles; olotadine hydrochloride eye drops 30 million bottles; levetila oral liquid 20 million bottles; risperidone oral liquid, entecavir oral liquid 30 million bottles; annual production of fasudil hydrochloride injection 30 million bottles, olacetam injection 50 million bottle preparation project production workshop, warehouse, etc.
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: Zhou Junhong
Technical person in charge: Cao Shuhua
Person in charge of process control: Wang Lin
Evaluation Report Compilers: Xu Zhe, Sun Guang, Gao Weili, Wang Ying, Zhao Yongzeng
Report Reviewer: Zhang Lijuan
Safety evaluators, registered safety engineers, and technical experts participating in the evaluation work: Zhou Junhong, Xu Zhe, Sun Guang, Gao Weili, Wang Ying, Zhao Yongzeng, Zhang Lijuan, Cao Shuhua
4. List of personnel, time, and main tasks to carry out safety evaluation work on site, and evaluation report time:
In March 2014, Hebei Anjian Chengyi Pharmaceutical Technology Co., Ltd. commissioned Hebei Science and Technology Consulting Co., Ltd. to evaluate the safety conditions of its national-level new drug API series products and preparation series product industrialization project (Phase I project), and signed a safety evaluation technical service contract. Huafei Company established an evaluation team in a timely manner, carefully collected relevant laws, regulations, standards and relevant information and accident case analysis of the same industry of the construction project, and went to the site to conduct on-site inspections of the project site, surrounding environment, production equipment and company safety management. The relevant personnel of Hebei Anjian Chengyi Pharmaceutical Technology Co., Ltd. were invited to introduce the relevant situation of the project.
During the evaluation process, the members of the evaluation team carefully analyzed and sorted out the relevant materials provided by the enterprise and collected on site, identified the dangerous and harmful factors existing in the project, conducted a qualitative and quantitative evaluation of the inherent danger degree of the project according to the divided evaluation units, and analyzed the risk degree of the project, put forward targeted safety countermeasures and suggestions, and fully communicated with the construction unit, exchanged opinions, and made a safety evaluation conclusion on this basis. In April 2014, the safety condition evaluation report of the project was completed. On April 27, 2014, Zhao County Safety Production Supervision and Administration Bureau organized experts to review the report and put forward revised opinions. The evaluation team has carefully revised the report in accordance with expert opinions and delivered it to the construction unit, which has been submitted to the Municipal Safety Supervision Bureau for administrative approval.