Anhui Zhongwang obtains drug production license
Release time:
2020-07-22
Anhui Zhongwang Obmed Drug Production License
News 11# August 25 , Anhui Zhongwang Pharmaceutical Co., Ltd. successfully obtained drug production license and successfully transformed from a pharmaceutical intermediate production enterprise to a drug production enterprise.
Starting from 2018 9 , Anhui Zhongwang Pharmaceutical has planned the company's organizational structure in strict accordance with GMP standard management requirements, established GMP document system, and compiled and perfected more than 24 technical standards, management standards and working standard documents 1100 , and completed the purified water system, air conditioning purification system, nitrogen system and production equipment and inspection equipment and other types of verification, a total of more than 100 ; on the basis of the original pharmaceutical intermediate production facilities and equipment, according to GMP requirements of the plant facilities and equipment have been upgraded, adding gas chromatograph, high performance liquid chromatograph, infrared spectrometer, drug stability test box, drug ultraviolet strong light irradiation test box and other inspection equipment; A new raw material medicine fine baking workshop and microbiology laboratory, as well as a purified water system and an air-conditioning purification system have been built, and the storage facilities and storage environment of the warehouse have been upgraded and improved.
By integrating the teams of Shanghai Beika and Zhongwang Pharmaceutical QA and QC , Anhui Zhongwang Company has basically met the personnel requirements of quality management and quality inspection required for the application of Drug Production License, and has established a personnel training management system, respectively compiled the company-level annual training plan and the department-level annual training plan, which are organized and implemented monthly as planned, focus on strengthening the training of relevant laws and regulations on drug production and GMP specification for personnel in key positions such as QA , QC , air conditioning purification system, purified water system, fine drying package workshop and warehouse, so as to improve the overall quality of personnel.
When the new "Drug Administration Law" is about to be implemented, the transformation and upgrading of Zhongwang Pharmaceuticals has laid a more solid foundation for the construction of the API base in the peak pharmaceutical sector. (Chen Lidong)
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