- Integrated chemical synthesis pilot workshop
- Chemical API production Workshop
- Oral Solid Dosage Form Workshop
- Small Volume Parenteral Solutions Workshop
- The wastewater treatment plant
- Advanced exhaust gas treatment facilities
- Treatment Storage and Disposal Facilities
Integrated chemical synthesis pilot workshop：The construction area of the workshop is 2,220 ㎡, of which the Grade D area is 400 m2. The workshop mainly sets up synthesis and refining procedures according to the production process of each product, and has air-conditioning system, purified water system, and 20L- 50L glass reactors, 200L- 2000L enamel glass/stainless steel reactors, molecular distillation, drying equipment and etc., which can meet the requirements for the lab and small-scale manufacturing of APIs.
COMPREHENSIVE POWER AND STORAGE FACILITIES
_
Well-equipped Power System: The powertrain equipped with gas-boiler (Ebara), which can provide a stable supply of steam. It also has two sets of purified water systems, one set of injection water and pure steam preparation systems, which can provide water for production. It also has multiple water ring pumps, roots vacuum pumps, claw vacuum pumps and refrigeration units at 7°C, -10°C, and -40°C in order to meet the needs of different working conditions and technologies.
Small Volume Parenteral Solutions Workshop: Located on the first floor of the production area, it has a gross floor area of 2,396㎡, with a production area of 1,189 ㎡, of which the Grade-D clean area is 256 ㎡ and the Grade-C clean area is 384 ㎡. The workshop is equipped with 500L automatic liquid dispensing systems, cleaning-drying and dilling-dealing production line(Chutian), and other matching facilities, and has an annual production capacity of 100 million units.
Compliance with cGMP Quality Management System and Professional Quality Control Laboratory
The company has established a robust quality management system and a management organization appropriate to the production of pharmaceutical products. It mainly includes the Quality Assurance Department, Quality Control Department, Storage and Transportation Department, Pharmacovigilance Department, Production Department, Engineering and Equipment Department, Supply Department and Human Resources Department; The key personnel and all managers are in line with the qualification requirements and the responsibilities of each organization and personnel are clearly defined. In order to strengthen quality risk management, the company has established a comprehensive documentation system, such as company technical standards, management procedures and operating procedures, etc. We have formulated a series of risk management documents which set out in detail the classification of risks, the responsibilities of personnel, the basic procedures for risk management, risk analysis tools, etc. The company provides GMP-related training to ensure the implementation of GMP standards. A GMP self- inspections team has been set up to regularly conduct comprehensive self-inspections of GMP implementation, promptly address any identified issues, and implement preventive measures. This continuous improvement approach contributes to continual improvement of the pharmaceutical quality system.
The Quality Control laboratory is located on the fourth and fifth floors of the comprehensive office building, separated from the production area, with a total area of 1600 ㎡. It is equipped with fully functional rooms and complete instrument facilities. It includes separated rooms for Physical and chemical testing, instrument testing, biological testing, microbiological limit testing, standard solution and titration solution preparation. The laboratory is equipped with advanced inspection instruments from internationally renowned brands, such as Liquid Chromatography, Gas Chromatography, Infrared Spectroscopy, UV-Visible Spectrophotometer, Particle size analyzer, and more. All the instruments can meet the inspection requirements of the company's products.