Manufacturing Sites

Qingdao Huashan Biochemical

Yesterday

2-larga.jpg

In 1998, setting up a pharmaceutical business in China was pioneering.
One of the few forerunners dated back to the beginning of the 1980s, when several Chinese researchers embarked on the process of extracting hormones from urine in the area between Nanjing and Hangzhou, organizing collection centers. However, in the mid-1990s, the logistical conditions of the rural villages in those regions, which underwent major transformation with the rapid development of rural entrepreneurship, meant that collection of these hormones was no longer easy.

When the management of IBSA decided to open a factory in China, the province of Shandong offered optimal conditions for starting the collection of the raw materials. At that time IBSA was able to count on the highly-organized system of villages, with ease of access to homes and potential donors, thanks to registers that systematically recorded the names of pregnant or menopausal women. Once the region was identified, all that remained to be done was to choose the place to build the production site. The choice fell on Huashan, a district in the vicinity of the city of Qingdao and the airport, with a broad concentration of densely-populated villages.

The mayor of Huashan became a fundamental go-between and was happy to provide the support needed to launch the project: following the discussion, the possibility of building the factory of a Swiss company in Huashan became a reality, simultaneously “overcoming” the impasse for industrial development in the area, where there was already a large number of small, easily-accessible buildings that were, however, completely unused.

It took 18 months to complete the legal procedures required to establish the Company and to obtain the necessary authorizations. And that is how Qingdao Huashan Biochemical Co. Ltd. came into being, a company that today IBSA can be prouder than ever.
 

Today

1.jpg

The Qingdao Huashan Biochemical production site occupies a total of more than 5 hectares and is located 60 km from Qingdao, in the province of Shandong.

The company specializes in the marketing and production of intermediate pharmaceutical products, with GMP-certified plants and equipment. The main products produced are human chorionic gonadotropin (hCG) and human menopausal gonadotropin (hMG) which, following processing at Qingdao, are further purified in Switzerland. A new project for the production of polysaccharides of fermentative origin was launched in 2016, with a patented process, based on fermentation and ultrafiltration technology.

Today the Qingdao site has four production plants, two research and development platforms, a warehouse, and a quality control department for physicochemical, microbiological and biological testing.

Over these twenty years we have expanded considerably. In 1998 the company had 12 employees, occupied 2,580 m2 with950 m2 of land suitable for development and only 80 m2 of green areas. Today, the green areas have grown to 9,000 m2, the total surface area occupied by the company is ten times larger and we still have 27,000 m2 available for future expansion. The team has also grown to 90 people.

With the enlargement of the company in 2017, its occupied surface area went from 10,000 m2 to 26,000 m2. From an industrial point of view, this resulted in the construction of a production plant for fermentative chondroitin, a production plant for crude FSH, a wastewater treatment system and a tank farm for solvents.

Considerable improvements have also been made that directly involve employees, namely the construction of a new Service Center that houses a canteen for 100 people, new dormitories for 23 employees and new guests and leisure areas equipped with a gym, table tennis tables and basketball court.

Quality System

A quality policy based on EU-GMP Part II and the ICHQ7 Guidelines is followed at the Qingdao site, in accordance with IBSA company policy and appropriate internal procedures, aimed at ensuring that all manufactured batches meet requirements in the fields of safety, identity, power, strength, quality, purity, coherence, reliability and stability.

All products conform to GMP standards and suppliers are systematically monitored in order to achieve high quality and compliance with legal requirements.

The plants have been designed and built in full respect of GMP standards, with a layout suitable for accommodating both human and logistic flows.
In 2017 the company passed the last GMP inspection (performed by Turkish Health Authorities).

The Qingdao Site in Figures

3-verticale.jpg

90 employees
Average age: 35 
Percentage of women: 35%

26,000 sqm. - total area 
7,000 sqm. - production areas and warehouses
5,000 sqm. - offices and services 
9,000 sqm. - green areas
27,000 sqm. - available for future expansion 

The site is made up of:

4 production plants
2 R&D laboratories 
1 waste water treatment system
1 enclosure
1 quality control laboratory 
1 warehouse 
1 office building 
1 service center with canteen, dormitories and leisure areas

Contacts

Qingdao Huashan Biochemical Co., Ltd.
No.48 Shanquan Road, Langu High-tech Industrial Development Zone, Jimo, Qingdao, Shandong P. R. of China

Phone: +86 532 84562606

* mandatory fields