Hebei Anjian Chengyi Pharmaceutical Technology Co., Ltd. Safety Conditions Evaluation Supplementary Report
Time：2018-08-17
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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 Supplementary Report
2. Introduction to the safety assessment project:
The first phase of the project was completed in May 2014 by Hebei Huafei Technology Consulting Co., Ltd. to compile the "Hebei Anjian Chengyi Pharmaceutical Technology Co., Ltd. National-level New Drug API Series Products and Preparation Series Products Industrialization Construction Project (Phase I Project) Safety Conditions Evaluation Report". The conclusion in the evaluation report on the surrounding environment and general layout of the plant site is that it meets the requirements of laws, regulations, standards and norms. The evaluation report passed the safety review organized by experts from Zhao County Safety Supervision Bureau and obtained a safety license opinion.
Due to the long construction period of the project and the changes in the surrounding facilities of the project plant, a preparation workshop was added to the general layout of the first phase of the project, the location of the Class A warehouse was adjusted, and the number and layout of the process flow and equipment were adjusted. The product variety, capacity and process route produced by this project have not changed. Due to the large adjustment of the layout of the general plan of this project, which caused the discrepancy between the approved and the actual general plan of the project to be implemented. It is necessary to evaluate the compliance after adjustment.
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 Ying
Evaluation Report Compilers: Zhou Junhong, Xu Zhe, Wang Lin
Report Reviewer: Gao Weili
4. List of personnel, time, and main tasks to carry out safety evaluation work on site, and evaluation report time:
Safety evaluators, registered safety engineers, and technical experts participating in the evaluation work: Xu Zhe, Wang Ying, Zhou Junhong, Wang Lin
In October 2017, Hebei Anjian Chengyi Pharmaceutical Technology Co., Ltd. commissioned Hebei Science and Technology Consulting Co., Ltd. to conduct a supplementary evaluation of safety conditions for the changes of the company's national-level new drug API series products and preparation series products industrialization construction project (Phase I project). Huafei Company established an evaluation team in a timely manner, carefully collected relevant laws, regulations, standards and relevant technical information, and went to the site to conduct on-site inspections of the project's surrounding environment, layout, process technology, equipment and facilities, public auxiliary projects and supporting facilities, and the company's safety management. The relevant information was collected, and the relevant personnel of the construction unit were invited to introduce the relevant situation of the project.
The evaluation report was completed in November 2017 and experts were hired to review the report, and suggestions for revisions were put forward. The evaluation team carefully revised the report according to the expert opinions and delivered it to the enterprise after improvement.