North China Pharmaceutical Joint Stock Company Water Needle Freeze-Dried Preparation Construction Project
Time：2014-01-18
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1. Safety evaluation project name: North China pharmaceutical joint stock company water needle freeze-dried preparation construction project
2. Introduction to the safety assessment project:
North China pharmaceutical joint stock company (hereinafter referred to as Huayao Company) is a joint stock enterprise established by the original North China pharmaceutical factory to invest all its production and operation assets, and through the issuance of shares. In June 2009, with the support of the State-owned Assets Supervision and Administration Commission of Hebei Province, Jizhong Energy reorganized the North China pharmaceutical joint stock company. Huayao joint stock company now has 5 branches and 11 subsidiaries.
The evaluation is North China pharmaceutical joint stock company (Keruite Branch) water needle lyophilized preparation construction project, the project to produce anti-tumor drugs, the main products are tega fluoride tablets and capsules, compound fluorouracil oral solution, norcantharidin tablets, paclitaxel injection.
This project is a new pharmaceutical preparation product project. The raw and auxiliary materials used in the production process of this project mainly include paclitaxel, polyoxyethylene castor oil, tegafluoride, pre-gelatinized starch, microcrystalline cellulose, sucrose, magnesium stearate, micronized silica gel, povidone K30, norcantharidin, Cellactose-80 (cellulose lactose), magnesium stearate, gelatin, sucrose, talc, Sichuan wax, lemon yellow, fluorouracil, oleic acid, cholesterol, vitamin E, benzoic acid, polysorbate 80, povidone K30, ginseng polysaccharide, bean phospholipid, etc., are not dangerous chemicals; the products tegafluoride tablets and capsules, compound fluorouracil oral solution, norcantharidin tablets, paclitaxel injection are also not dangerous chemicals The excipient used in the process - compressed air (mainly used as instrument gas) - is a hazardous chemical.
The project was initiated and started construction in December 2008. After the unremitting efforts of the construction unit, design unit, construction unit, supervision unit and relevant parties, the construction was completed in December 2011. Since March 2012, the project has carried out trial production and mass production operations. During the production process, the company improved various safety facilities while carrying out production commissioning, and carried out safety acceptance safety evaluation work, meeting the conditions for safe completion acceptance.
According to the contract signed between Huayao Company and Huafei Company, the object of this safety evaluation is the site selection, layout, production equipment, public works and auxiliary facilities, and safety management of Huayao Company's water needle lyophilized preparation construction project.
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
Compilers of the evaluation report: Gao Weili, Xu Zhe, Sun Guang, Ma Junxing
Report Reviewer: Zhang Lijuan
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: Gao Weili, Xu Zhe, Sun Guang, Ma Junxing
In November 2012, the report completed the "North China pharmaceutical joint stock company water needle freeze-dried preparation construction project safety acceptance evaluation report" submitted version.
On December 26, 2012, the Shijiazhuang Safety Production Supervision and Administration Bureau organized relevant experts to review the submitted version of the report. The experts attending the meeting believed that the report complied with the requirements of relevant laws, regulations, standards and norms, passed the review of the report, and put forward amendments. Our company's evaluators made serious revisions and improvements to the "Report" in accordance with expert opinions. On January 26, 2013, the filing version of the "Report" was completed.